Trial Outcomes & Findings for Deep Brain Stimulation (DBS) for the Suppression of Tremor (NCT NCT02087046)

NCT ID: NCT02087046

Last Updated: 2023-04-25

Results Overview

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 127 participants
• Primary outcome timeframe: Day 180
• Results posted on: 2023-04-25

Participant Flow

A total of 127 patients were enrolled from 12 investigational sites and implanted with the study device. The first patient was implanted with the SJM DBS Systems on 21 October, 2005. Of the 127 implanted subjects, 80 received unilateral implants and the remaining 47 patients received bilateral implants.

Of the 150 subjects who were screened, 23 subjects were excluded from implantation due to inclusion or exclusion criteria, or the patient's decision to discontinue before surgery.

Participant milestones

Measure	Stimulation ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Overall Study STARTED	127
Overall Study Primary Endpoint	121
Overall Study COMPLETED	116
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Measure	Stimulation ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Overall Study Adverse Event	4
Overall Study Death	1
Overall Study Lost to Follow-up	3
Overall Study Withdrawal by Subject	2
Overall Study Physician Decision	1

Baseline Characteristics

Deep Brain Stimulation (DBS) for the Suppression of Tremor

Baseline characteristics by cohort

Measure	Stimulation n=127 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Age, Continuous	64.6 years STANDARD_DEVIATION 9.6 • n=5 Participants
Sex: Female, Male Female	58 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	124 participants n=5 Participants
Race/Ethnicity, Customized African American	1 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	2 participants n=5 Participants
Region of Enrollment United States	127 participants n=5 Participants
Years since onset of tremor	29.1 years STANDARD_DEVIATION 17.4 • n=5 Participants
Years since initial diagnosis of ET	14.8 years STANDARD_DEVIATION 11.8 • n=5 Participants

PRIMARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

Outcome measures

Measure	Stimulation n=76 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer Stimulation Off	2.09 units on a scale Standard Deviation 1.07
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer Stimulation On	0.84 units on a scale Standard Deviation 0.83
Primary Efficacy Endpoint: Difference in the Postural Tremor Score of the Target Limb Between Stimulation On and Stimulation Off, As Assessed by the Blind Reviewer Mean Difference	-1.25 units on a scale Standard Deviation 1.26

PRIMARY outcome

Timeframe: Within 180 days following the initial implant

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Percentage of device-related or procedure related adverse events will be assessed within 6 months following the initial unilateral implant. All such adverse events will be counted for 180 days following surgery or until the day of the second implant, which ever comes first.

Outcome measures

Measure	Stimulation n=127 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Primary Safety Endpoint: Percentage of Participants With Device-related or Procedure Related Adverse Events	31.5 percentage of participants

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician	3.10 score on a scale Standard Deviation 0.62

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

Outcome measures

Measure	Stimulation n=121 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Stimulation Off	2.41 score on a scale Standard Deviation 0.98
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Stimulation On	0.75 score on a scale Standard Deviation 0.78
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Mean Difference	-1.66 score on a scale Standard Deviation 1.07

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Stimulation Off	2.41 score on a scale Standard Deviation 0.96
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Stimulation On	0.67 score on a scale Standard Deviation 0.70
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Mean Difference	-1.74 score on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

Outcome measures

Measure	Stimulation n=112 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Stimulation Off	2.55 score on a scale Standard Deviation 1.12
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Stimulation On	0.62 score on a scale Standard Deviation 0.79
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Target Limb Severity Score, As Assessed by the Site Physician Mean Difference	-1.94 score on a scale Standard Deviation 1.16

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings.

Outcome measures

Measure	Stimulation n=121 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician Between Stimulation OFF and Stimulation ON	67 Participants
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician Between Baseline and Stimulation ON	98 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings.

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician Between Stimulation OFF and Stimulation ON	69 Participants
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician Between Baseline and Stimulation ON	98 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

During responder analysis, a 2-point reduction in kinetic tremor or postural tremor between stimulation Off and stimulation On show an improvement in activities of daily living was considered a response, was also performed using the site physician's ratings.

Outcome measures

Measure	Stimulation n=112 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician Between Stimulation OFF and Stimulation ON	72 Participants
Clinical Rating Scale for Tremor (CRST) Evaluation- Target Limb Responder Analysis, As Assessed by the Site Physician Between Baseline and Stimulation ON	97 Participants

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician	2.66 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).

Outcome measures

Measure	Stimulation n=121 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Stimulation Off	2.18 score on a scale Standard Deviation 1.14
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Stimulation On	0.93 score on a scale Standard Deviation 0.91
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Mean Difference	-1.25 score on a scale Standard Deviation 0.95

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).

Outcome measures

Measure	Stimulation n=117 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Stimulation Off	2.22 score on a scale Standard Deviation 1.08
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Stimulation On	0.91 score on a scale Standard Deviation 0.89
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Mean Difference	-1.32 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's handwriting according to the CRST (scale 0-4).

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Stimulation On	0.90 score on a scale Standard Deviation 0.87
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Stimulation Off	2.32 score on a scale Standard Deviation 1.14
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Site Physician Mean Difference	-1.42 score on a scale Standard Deviation 1.10

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The blind reviewer will evaluate the patient's handwriting according to the CRST (scale 0-4).

Outcome measures

Measure	Stimulation n=58 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer Stimulation Off	1.69 score on a scale Standard Deviation 1.10
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer Stimulation On	0.62 score on a scale Standard Deviation 0.72
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Handwriting for Target Side Severity Score, As Assessed by the Blind Reviewer Mean Difference	-1.07 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's pouring ability according to the CRST

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician	2.56 score on a scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's pouring ability according to the CRST

Outcome measures

Measure	Stimulation n=121 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Stimulation Off	2.25 score on a scale Standard Deviation 1.14
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Stimulation On	0.68 score on a scale Standard Deviation 0.90
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Mean Difference	-1.57 score on a scale Standard Deviation 1.17

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's pouring ability according to the CRST

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Mean Difference	-1.52 score on a scale Standard Deviation 1.11
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Stimulation Off	2.08 score on a scale Standard Deviation 1.19
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Stimulation On	0.57 score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The site physician will evaluate the patient's pouring ability according to the CRST

Outcome measures

Measure	Stimulation n=112 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Stimulation Off	2.16 score on a scale Standard Deviation 1.31
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Stimulation On	0.62 score on a scale Standard Deviation 0.91
Clinical Rating Scale for Tremor (CRST) Evaluation-Mean Pouring From Target Side Severity Scores, As Assessed by the Site Physician Mean Difference	-1.54 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The blind reviewer will evaluate the patient's pouring ability according to the CRST

Outcome measures

Measure	Stimulation n=50 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer Stimulation Off	1.56 score on a scale Standard Deviation 1.13
Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer Stimulation On	0.70 score on a scale Standard Deviation 0.86
Clinical Rating Scale for Tremor (CRST) Evaluation- Pouring Ability From Target Side Severity Scores, As Assessed by the Blind Reviewer Mean Difference	-0.86 score on a scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician	16.9 score on a scale Standard Deviation 5.9

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).

Outcome measures

Measure	Stimulation n=119 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Stimulation Off	13.1 score on a scale Standard Deviation 6.8
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Stimulation On	7.9 score on a scale Standard Deviation 4.8
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Mean Difference	-5.2 score on a scale Standard Deviation 3.8

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).

Outcome measures

Measure	Stimulation n=116 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Stimulation Off	13.6 score on a scale Standard Deviation 6.9
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Stimulation On	7.4 score on a scale Standard Deviation 4.1
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Mean Difference	-6.2 score on a scale Standard Deviation 4.8

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The motor score adds together all responses to the tremor assessment for questions 1-9 of the CRST (whether or not the specific side is being treated).

Outcome measures

Measure	Stimulation n=112 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Stimulation Off	14.6 score on a scale Standard Deviation 8.8
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Stimulation On	7.2 score on a scale Standard Deviation 5.0
Clinical Rating Scale for Tremor (CRST) Evaluation- Mean Total Motor Score, As Assessed by the Site Physician Mean Difference	-7.4 score on a scale Standard Deviation 6.6

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The activity of daily living score adds together all responses to questions 15-21 of the CRST.

Outcome measures

Measure	Stimulation n=123 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician	16.3 score on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

The activity of daily living score adds together all responses to questions 15-21 of the CRST.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Stimulation Off	13.8 score on a scale Standard Deviation 6.1
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Stimulation On	5.0 score on a scale Standard Deviation 4.7
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Mean Difference	-8.8 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST.

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Stimulation Off	14.3 score on a scale Standard Deviation 6.2
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Stimulation On	5.2 score on a scale Standard Deviation 4.6
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Mean Difference	-9.1 score on a scale Standard Deviation 6.1

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms. The activity of daily living score adds together all responses to questions 15-21 of the CRST.

Outcome measures

Measure	Stimulation n=107 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Stimulation Off	14.7 score on a scale Standard Deviation 6.5
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Stimulation On	4.6 score on a scale Standard Deviation 4.7
Clinical Rating Scale for Tremor (CRST) Evaluation- Activity of Daily Living Score, As Assessed by the Site Physician Mean Difference	-10.0 score on a scale Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days of bilateral stimulation.

Outcome measures

Measure	Stimulation n=39 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician	2.82 score on a scale Standard Deviation 0.76

SECONDARY outcome

Timeframe: Following 180 days of stimulation

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days of bilateral stimulation.

Outcome measures

Measure	Stimulation n=39 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician Stimulation On	0.95 score on a scale Standard Deviation 0.89
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician Mean Difference	-1.72 score on a scale Standard Deviation 1.00
Clinical Rating Scale for Tremor (CRST) Evaluation-Bilateral Stimulation, As Assessed by the Site Physician Stimulation Off	2.67 score on a scale Standard Deviation 0.87

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days with only the second side system On

Outcome measures

Measure	Stimulation n=37 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician	2.84 score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: Following 180 days of stimulation

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Fahn, Tolosa, Marin Tremor Rating Scale (referred to as the CRST), is a rating tool to assess the severity of postural, isometric, kinetic and task specific tremor in the dominant and non-dominant sides of the head, trunk and limbs of patients with ET. The CRST utilizes a 0 to 4 point scale where 0 indicates non-symptomatic (normal) and 4 indicates the most severe rating of the patient's tremor symptoms.

For those patients that had bilateral stimulation, the site physician will evaluate the patient's non-target side after 180 days with only the second side system On

Outcome measures

Measure	Stimulation n=37 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician Stimulation Off	2.73 score on a scale Standard Deviation 0.90
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician Stimulation On	1.11 score on a scale Standard Deviation 1.07
Clinical Rating Scale for Tremor (CRST) Evaluation-Non-Target Limb Severity Scores, As Assessed by the Site Physician Mean Difference	-1.62 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Stimulation n=123 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Quality of Life in Essential Tremor (QUEST): Overall Summary Index	49.1 score on a scale Standard Deviation 12.6

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index Summary Index Mean	33.1 score on a scale Standard Deviation 16.8
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index Mean Change in Summary Index	-16.0 score on a scale Standard Deviation 15.5

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index Summary Index Mean	33.0 score on a scale Standard Deviation 16.2
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index Mean Change in Summary Index	-15.9 score on a scale Standard Deviation 16.9

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. As the scores were expressed as percentages, if a question was unanswered it was excluded and percentages were calculated based on the remaining answers. A total or quest summary index (QSI) was computed by calculating the mean of the five scales. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index Summary Index	30.9 score on a scale Standard Deviation 16.4
Change From Baseline for Quality of Life in Essential Tremor (QUEST): Overall Summary Index Mean Change in Summary Index	-18.0 score on a scale Standard Deviation 15.4

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.

Outcome measures

Measure	Stimulation n=123 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
SF36 Components and Individual Domains Physical Component Summary	45.62 score on a scale Standard Deviation 9.49
SF36 Components and Individual Domains Mental Component Summary	50.11 score on a scale Standard Deviation 10.9

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
SF36 Components and Individual Domains Physical Component Summary	47.21 score on a scale Standard Deviation 8.45
SF36 Components and Individual Domains Mental Component Summary	52.71 score on a scale Standard Deviation 8.07

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.

Outcome measures

Measure	Stimulation n=117 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
SF36 Components and Individual Domains Physical Component Summary	46.82 score on a scale Standard Deviation 9.94
SF36 Components and Individual Domains Mental Component Summary	51.85 score on a scale Standard Deviation 9.51

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The SF-36 questionnaire is a measure of health status with 36 items across 8 domains. The eight domains are separated into two summary scores of four domains, the physical component summary (PCS) and mental component summary (MCS). The SF-36 score is transformed into a scale of 0-100, with 100 indicating no disability. PCS and MCS are scaled in comparison to population norms to reflect a mean of 50 and standard deviation of 10 for the general population of the United States.

Outcome measures

Measure	Stimulation n=108 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
SF36 Components and Individual Domains Physical Component Summary	45.6 score on a scale Standard Deviation 9.79
SF36 Components and Individual Domains Mental Component Summary	52.21 score on a scale Standard Deviation 10.15

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment Scores by Examiner No disability	0 Participants
Global Assessment Scores by Examiner Mild disability	2 Participants
Global Assessment Scores by Examiner Moderate disability	35 Participants
Global Assessment Scores by Examiner Marked disability	68 Participants
Global Assessment Scores by Examiner Severe disability	17 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment Scores by Examiner No disability	28 Participants
Global Assessment Scores by Examiner Mild disability	66 Participants
Global Assessment Scores by Examiner Moderate disability	21 Participants
Global Assessment Scores by Examiner Marked disability	5 Participants
Global Assessment Scores by Examiner Severe disability	2 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment Scores by Examiner No disability	31 Participants
Global Assessment Scores by Examiner Mild disability	57 Participants
Global Assessment Scores by Examiner Moderate disability	25 Participants
Global Assessment Scores by Examiner Marked disability	5 Participants
Global Assessment Scores by Examiner Severe disability	0 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the examiner's interpretation of the patient's quality of life.

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment Scores by Examiner No disability	36 Participants
Global Assessment Scores by Examiner Mild disability	55 Participants
Global Assessment Scores by Examiner Moderate disability	14 Participants
Global Assessment Scores by Examiner Marked disability	4 Participants
Global Assessment Scores by Examiner Severe disability	1 Participants

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life

Outcome measures

Measure	Stimulation n=68 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Caregiver No disability	0 Participants
Global Assessment by Caregiver Mild disability	2 Participants
Global Assessment by Caregiver Moderate disability	15 Participants
Global Assessment by Caregiver Marked disability	32 Participants
Global Assessment by Caregiver Severe disability	19 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life

Outcome measures

Measure	Stimulation n=72 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Caregiver No disability	19 Participants
Global Assessment by Caregiver Mild disability	33 Participants
Global Assessment by Caregiver Moderate disability	13 Participants
Global Assessment by Caregiver Marked disability	5 Participants
Global Assessment by Caregiver Severe disability	2 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life

Outcome measures

Measure	Stimulation n=66 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Caregiver No disability	21 Participants
Global Assessment by Caregiver Mild disability	26 Participants
Global Assessment by Caregiver Moderate disability	11 Participants
Global Assessment by Caregiver Marked disability	6 Participants
Global Assessment by Caregiver Severe disability	2 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire that measures a global assessment of the patient quality of life and the caregiver's interpretation of the patient's quality of life

Outcome measures

Measure	Stimulation n=70 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Caregiver No disability	25 Participants
Global Assessment by Caregiver Mild disability	28 Participants
Global Assessment by Caregiver Moderate disability	11 Participants
Global Assessment by Caregiver Marked disability	4 Participants
Global Assessment by Caregiver Severe disability	2 Participants

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit

Outcome measures

Measure	Stimulation n=123 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Patient No disability	2 Participants
Global Assessment by Patient Mild disability	3 Participants
Global Assessment by Patient Moderate disability	27 Participants
Global Assessment by Patient Marked disability	59 Participants
Global Assessment by Patient Severe disability	32 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Patient No disability	28 Participants
Global Assessment by Patient Mild disability	57 Participants
Global Assessment by Patient Moderate disability	25 Participants
Global Assessment by Patient Marked disability	9 Participants
Global Assessment by Patient Severe disability	3 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Patient No disability	35 Participants
Global Assessment by Patient Mild disability	50 Participants
Global Assessment by Patient Moderate disability	21 Participants
Global Assessment by Patient Marked disability	11 Participants
Global Assessment by Patient Severe disability	1 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Global outcome measures are a self-rated questionnaire in which patients assess their own global outcome at each visit

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Global Assessment by Patient No disability	38 Participants
Global Assessment by Patient Mild disability	45 Participants
Global Assessment by Patient Moderate disability	20 Participants
Global Assessment by Patient Marked disability	6 Participants
Global Assessment by Patient Severe disability	1 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change.

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Subjective Assessment by Patient Since Activation of System Marked improvement	76 Participants
Subjective Assessment by Patient Since Activation of System Moderate improvement	23 Participants
Subjective Assessment by Patient Since Activation of System Mild improvement	8 Participants
Subjective Assessment by Patient Since Activation of System Unchanged	6 Participants
Subjective Assessment by Patient Since Activation of System Mild worsening	7 Participants
Subjective Assessment by Patient Since Activation of System Moderate worsening	0 Participants
Subjective Assessment by Patient Since Activation of System Marked worsening	2 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change.

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Subjective Assessment by Patient Since Activation of System Marked improvement	22 Participants
Subjective Assessment by Patient Since Activation of System Moderate improvement	12 Participants
Subjective Assessment by Patient Since Activation of System Mild improvement	17 Participants
Subjective Assessment by Patient Since Activation of System Unchanged	46 Participants
Subjective Assessment by Patient Since Activation of System Mild worsening	18 Participants
Subjective Assessment by Patient Since Activation of System Moderate worsening	3 Participants
Subjective Assessment by Patient Since Activation of System Marked worsening	0 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

Subjective assessment includes changes in their ET symptoms since the last visit indicated as marked improvement, moderate improvement, mild improvement, worsening, or no change.

Outcome measures

Measure	Stimulation n=109 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Subjective Assessment by Patient Since Activation of System Marked improvement	17 Participants
Subjective Assessment by Patient Since Activation of System Moderate improvement	13 Participants
Subjective Assessment by Patient Since Activation of System Mild improvement	16 Participants
Subjective Assessment by Patient Since Activation of System Unchanged	45 Participants
Subjective Assessment by Patient Since Activation of System Mild worsening	14 Participants
Subjective Assessment by Patient Since Activation of System Moderate worsening	3 Participants
Subjective Assessment by Patient Since Activation of System Marked worsening	1 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Very Satisfied	78 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Satisfied	27 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Indifferent	7 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Not Satisfied	3 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Very Unsatisfied	7 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Very Satisfied	77 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Satisfied	28 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Indifferent	4 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Not Satisfied	5 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Very Unsatisfied	4 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked about their satisfaction with the DBS system's functioning and ability to control symptoms

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Very Satisfied	76 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Satisfied	22 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Indifferent	2 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Not Satisfied	7 Participants
Number of Participants With Satisfaction With the DBS System's Functioning and Ability to Control Symptoms Very Unsatisfied	3 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked if they would undergo the DBS procedure again

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants Who Would Choose to Receive the DBS System Again	106 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked if they would undergo the DBS procedure again

Outcome measures

Measure	Stimulation n=118 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants Who Would Choose to Receive the DBS System Again	111 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked if they would undergo the DBS procedure again

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants Who Would Choose to Receive the DBS System Again	98 Participants

SECONDARY outcome

Timeframe: Day 90

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked if they would recommend the DBS system to others

Outcome measures

Measure	Stimulation n=122 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants Who Would Recommend the DBS System	117 Participants

SECONDARY outcome

Timeframe: Day 180

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked if they would recommend the DBS system to others

Outcome measures

Measure	Stimulation n=117 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants Who Would Recommend the DBS System	113 Participants

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

At each visit, patients will be asked if they would recommend the DBS system to others

Outcome measures

Measure	Stimulation n=100 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Number of Participants Who Would Recommend the DBS System	98 Participants

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Beck Depression Inventory II is A clinical rating scale designed for detecting depression based on the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV) criteria. This widely used instrument consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The BDI II questionnaire contains 21 questions, each answer being scored on a scale value of 0 to 3. A score between 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression. Total scores are obtained by computing the sum of each score. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.

Outcome measures

Measure	Stimulation n=112 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Beck Depression Inventory II (BDI - II) Score for Depression Symptoms	8.8 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Beck Depression Inventory II is A clinical rating scale designed for detecting depression based on the Diagnostic and Statistical Manual of Mental Health Disorders-Fourth Edition (DSM-IV) criteria. This widely used instrument consists of 21 items to assess the intensity of depression in clinical and normal patients. Each item is a list of four statements arranged in increasing severity about a particular symptom of depression. The BDI II questionnaire contains 21 questions, each answer being scored on a scale value of 0 to 3. A score between 0-13 indicates minimal depression, 14-19 mild depression, 20-28 moderate depression and 29-63 severe depression. Total scores are obtained by computing the sum of each score. The scores range from 0 to 63, with higher score indicating greater severity of depressive symptoms.

Outcome measures

Measure	Stimulation n=112 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Change From Baseline in Beck Depression Inventory II (BDI - II) Score for Depression Symptoms Mean Score	6.8 score on a scale Standard Deviation 7.1
Change From Baseline in Beck Depression Inventory II (BDI - II) Score for Depression Symptoms Mean Change in Score	-2.0 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: Baseline

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition.

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Mini Mental State Exam (MMSE) for Examination of Mental Status	29.2 score on a scale Standard Deviation 1.2

SECONDARY outcome

Timeframe: Day 365

Population: The number of participants analyzed includes subjects who were available at that time of analysis

The Mini-Mental State Examination (MMSE) is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. It examines functions including registration (repeating named prompts), attention and calculation, recall, language, ability to follow simple commands and orientation. Any score of 24 or more (out of 30) indicates a normal cognition.

Outcome measures

Measure	Stimulation n=110 Participants ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Change From Baseline in Mini Mental State Exam (MMSE) For Examination of Mental Status Mean Score	29.1 score on a scale Standard Deviation 1.4
Change From Baseline in Mini Mental State Exam (MMSE) For Examination of Mental Status Mean Change in Score	-0.1 score on a scale Standard Deviation 1.2

Adverse Events

Stimulation

Serious events: 28 serious events

Other events: 91 other events

Deaths: 3 deaths

Serious adverse events

Measure	Stimulation n=127 participants at risk ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Cardiac disorders Atrial Fibrillation	0.79% 1/127 • Number of events 1 • 1 year
Cardiac disorders Cardiac Surgery	0.79% 1/127 • Number of events 1 • 1 year
Cardiac disorders Myocardiac Infarction	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Bleeding Gastric Ulcer	1.6% 2/127 • Number of events 2 • 1 year
General disorders Death	2.4% 3/127 • Number of events 3 • 1 year
General disorders Worsening of Pre-Existing Condition	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Cellulitis	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Infection	1.6% 2/127 • Number of events 3 • 1 year
Infections and infestations Septic Shock	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Wound Dehiscence	1.6% 2/127 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Back Pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Fall With Broken Femur	0.79% 1/127 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Cancer	0.79% 1/127 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	1.6% 2/127 • Number of events 2 • 1 year
Nervous system disorders Intracranial Edema	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Intracranial Hemorrhage Non Symptomatic	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Intracranial Hemorrhage Symptomatic Persistant	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Intracranial Hemorrhage Symptomatic Transient	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Paresis	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Right Hemiparesis	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Seizure	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Stroke	0.79% 1/127 • Number of events 1 • 1 year
Psychiatric disorders Depression	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Epistaxis	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Pneumonia	0.79% 1/127 • Number of events 1 • 1 year
Surgical and medical procedures Air Embolism	0.79% 1/127 • Number of events 1 • 1 year
Vascular disorders Untreated Hypertension	0.79% 1/127 • Number of events 1 • 1 year

Other adverse events

Measure	Stimulation n=127 participants at risk ANS Totally Implantable Deep BrainStimulation System: ANS Totally Implantable Deep BrainStimulation System will be implanted in the VIM nucleus of the thalamus
Cardiac disorders Congestive heart failure	0.79% 1/127 • Number of events 2 • 1 year
Cardiac disorders Palpitations	0.79% 1/127 • Number of events 1 • 1 year
Ear and labyrinth disorders Tinnitus	0.79% 1/127 • Number of events 1 • 1 year
Endocrine disorders Diabetes	0.79% 1/127 • Number of events 1 • 1 year
Eye disorders Blurred vision left eye	0.79% 1/127 • Number of events 1 • 1 year
Eye disorders Double vision	1.6% 2/127 • Number of events 2 • 1 year
Eye disorders Right eye retinal detachment	0.79% 1/127 • Number of events 1 • 1 year
Eye disorders Visual disturbances	5.5% 7/127 • Number of events 7 • 1 year
Eye disorders Worsening cataracts	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Constipation	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Decreased taste sensation	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Diarrhea	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Difficulty swallowing	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Dysphagia	3.9% 5/127 • Number of events 5 • 1 year
Gastrointestinal disorders Fecal incontinence	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Gastric reflux	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Increased dysphagia	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Nausea	0.79% 1/127 • Number of events 1 • 1 year
Gastrointestinal disorders Stomach pain	0.79% 1/127 • Number of events 1 • 1 year
General disorders Atypical chest pain	0.79% 1/127 • Number of events 1 • 1 year
General disorders Gait disorder including balance problem	8.7% 11/127 • Number of events 11 • 1 year
General disorders Head cold	0.79% 1/127 • Number of events 1 • 1 year
General disorders Heat Intolerance	0.79% 1/127 • Number of events 1 • 1 year
General disorders Hiccups	0.79% 1/127 • Number of events 1 • 1 year
General disorders Hoarseness	1.6% 2/127 • Number of events 2 • 1 year
General disorders Hypophonia	1.6% 2/127 • Number of events 2 • 1 year
General disorders Jolting or shocking sensations	13.4% 17/127 • Number of events 18 • 1 year
General disorders Left chest discomfort	0.79% 1/127 • Number of events 1 • 1 year
General disorders Lightheadedness	2.4% 3/127 • Number of events 3 • 1 year
General disorders Loss of tremor relief	0.79% 1/127 • Number of events 1 • 1 year
General disorders Lower extremity edema	0.79% 1/127 • Number of events 1 • 1 year
General disorders Lower leg cramps at night	0.79% 1/127 • Number of events 1 • 1 year
General disorders RLE cramping, pain	0.79% 1/127 • Number of events 1 • 1 year
General disorders Right foot edema	0.79% 1/127 • Number of events 1 • 1 year
General disorders Right shoulder soreness	0.79% 1/127 • Number of events 1 • 1 year
General disorders Right thumb triggering	0.79% 1/127 • Number of events 1 • 1 year
General disorders Sialorrhea	0.79% 1/127 • Number of events 1 • 1 year
General disorders Sialorrhea - right side of mouth	0.79% 1/127 • Number of events 1 • 1 year
General disorders Slight worsening of balance	0.79% 1/127 • Number of events 1 • 1 year
General disorders Tightness, chest	0.79% 1/127 • Number of events 1 • 1 year
General disorders Tingling in Left arm	0.79% 1/127 • Number of events 1 • 1 year
General disorders Tooth decay	0.79% 1/127 • Number of events 1 • 1 year
General disorders Weakness	1.6% 2/127 • Number of events 2 • 1 year
General disorders Weakness LUE	0.79% 1/127 • Number of events 1 • 1 year
General disorders Word recall	0.79% 1/127 • Number of events 1 • 1 year
General disorders Worsening of handwriting	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Flu	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Heavy sinus drainage	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Infection	4.7% 6/127 • Number of events 6 • 1 year
Infections and infestations Left breast abscess	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Left leg edema & cellulitis unrelated to device/surgery	0.79% 1/127 • Number of events 1 • 1 year
Infections and infestations Left shoulder brusitis	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Burning sensation over implant site	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications DBS system malfunction	2.4% 3/127 • Number of events 3 • 1 year
Injury, poisoning and procedural complications Dental bridge broke	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Difficult implant of extensions	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Drainage from IPG incision line	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Fall	1.6% 2/127 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Frontal incision erythemic	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Intermittent stimulation	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Left Frontal Incision Erythemic	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Left collor bone fracture from fall	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Left leg drags when stimulation is on	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Loss of stimulation	4.7% 6/127 • Number of events 6 • 1 year
Injury, poisoning and procedural complications Medial Lead Placement Stimulation-Induced Side Effects	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Mild redness over post-auricular incision	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Persistent pain at IPG site	1.6% 2/127 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Post operative discomfort	3.1% 4/127 • Number of events 4 • 1 year
Injury, poisoning and procedural complications Post operative pain	1.6% 2/127 • Number of events 2 • 1 year
Injury, poisoning and procedural complications Right arm bruising, hair line fracture	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Right hip fracture from fall	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Right hip pain from fall	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Swelling in area of left extension wire	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Tenderness around connector site	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Undesirable changes in stimulation	0.79% 1/127 • Number of events 1 • 1 year
Injury, poisoning and procedural complications Unsteadiness of right leg when stimulation on	0.79% 1/127 • Number of events 1 • 1 year
Investigations Elevated PSA	0.79% 1/127 • Number of events 1 • 1 year
Investigations Hypercholesterolemia	0.79% 1/127 • Number of events 1 • 1 year
Investigations Increased heart rate	0.79% 1/127 • Number of events 1 • 1 year
Metabolism and nutrition disorders Dehydration	0.79% 1/127 • Number of events 1 • 1 year
Metabolism and nutrition disorders Diminished appetite	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Back pain	2.4% 3/127 • Number of events 3 • 1 year
Musculoskeletal and connective tissue disorders Bilateral hip pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Bilateral leg pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Cervical pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Dysarthria	15.7% 20/127 • Number of events 20 • 1 year
Musculoskeletal and connective tissue disorders Dystonia	2.4% 3/127 • Number of events 3 • 1 year
Musculoskeletal and connective tissue disorders Foot pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Gout	1.6% 2/127 • Number of events 2 • 1 year
Musculoskeletal and connective tissue disorders Hand/ joint pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Left foot pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Left hip pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Left hip strain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Left knee pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Left sciatic leg pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Myalgia	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Neck pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Osteopenia by bone density scan	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Right knee pain	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Tennis elbow	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Worsening RLS symptoms	0.79% 1/127 • Number of events 1 • 1 year
Musculoskeletal and connective tissue disorders Worsening of myasthenia gravis	0.79% 1/127 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bakers cyst	0.79% 1/127 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.79% 1/127 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Left adnexal cyst	0.79% 1/127 • Number of events 1 • 1 year
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Aphasia	2.4% 3/127 • Number of events 3 • 1 year
Nervous system disorders Arm jerks periodically	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Ataxia	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Cognitive problems	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Development of PD symptoms	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Diminished tremor relief	3.1% 4/127 • Number of events 4 • 1 year
Nervous system disorders Disequilibrium	3.9% 5/127 • Number of events 5 • 1 year
Nervous system disorders Dizziness	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Head tremor	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Headache	9.4% 12/127 • Number of events 13 • 1 year
Nervous system disorders Inadequate tremor control	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Intermittent jerky movement of right hand	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Lethargy	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Myoclonic jerks	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Paresis	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Paresthesia	3.1% 4/127 • Number of events 4 • 1 year
Nervous system disorders Postural instability	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Short term memory problems	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Spelling difficulty-writes or types words with errors	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Vivid dreaming	0.79% 1/127 • Number of events 1 • 1 year
Nervous system disorders Worsened tremor	0.79% 1/127 • Number of events 1 • 1 year
Psychiatric disorders Abnormal thinking	0.79% 1/127 • Number of events 1 • 1 year
Psychiatric disorders Anxiety	1.6% 2/127 • Number of events 2 • 1 year
Psychiatric disorders Confusion	3.9% 5/127 • Number of events 6 • 1 year
Psychiatric disorders Depression	4.7% 6/127 • Number of events 6 • 1 year
Psychiatric disorders Hyperinsomnia	0.79% 1/127 • Number of events 1 • 1 year
Psychiatric disorders Insomnia	0.79% 1/127 • Number of events 1 • 1 year
Psychiatric disorders Psychiatric changes	0.79% 1/127 • Number of events 1 • 1 year
Psychiatric disorders Sleep Walking	0.79% 1/127 • Number of events 1 • 1 year
Renal and urinary disorders Kidney stones	1.6% 2/127 • Number of events 2 • 1 year
Renal and urinary disorders Urinary Tract infection	2.4% 3/127 • Number of events 3 • 1 year
Renal and urinary disorders Urinary frequency	0.79% 1/127 • Number of events 1 • 1 year
Renal and urinary disorders Urinary incontinence	0.79% 1/127 • Number of events 1 • 1 year
Reproductive system and breast disorders Amenorrhea	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Bronchitis	1.6% 2/127 • Number of events 3 • 1 year
Respiratory, thoracic and mediastinal disorders Choking	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Cough	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Intermittent Aspiration	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Left chest hematoma	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Mold allergy resulting in asthma	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Productive cough	1.6% 2/127 • Number of events 2 • 1 year
Respiratory, thoracic and mediastinal disorders Respiratory infection	0.79% 1/127 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Upper respiratory infection	1.6% 2/127 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders Erythema	0.79% 1/127 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Erythema over IPG site	0.79% 1/127 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Multiple skin lesions face, arm, back	0.79% 1/127 • Number of events 1 • 1 year
Skin and subcutaneous tissue disorders Rash	1.6% 2/127 • Number of events 2 • 1 year
Skin and subcutaneous tissue disorders Skin lesion	2.4% 3/127 • Number of events 3 • 1 year
Skin and subcutaneous tissue disorders Subcutaneous hematoma	0.79% 1/127 • Number of events 1 • 1 year
Surgical and medical procedures Elective left carpal tunnel release surgery	0.79% 1/127 • Number of events 1 • 1 year
Vascular disorders Hypertension	0.79% 1/127 • Number of events 1 • 1 year
Vascular disorders Hypotension	0.79% 1/127 • Number of events 1 • 1 year

Additional Information

Clinical Research Scientist

Abbott

Phone: 972-309-8000

Email: mike.frassica@abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place