Trial Outcomes & Findings for Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool (NCT NCT03794661)

NCT ID: NCT03794661

Last Updated: 2022-03-31

Results Overview

Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 8 participants
• Primary outcome timeframe: At Day 21 compared to baseline
• Results posted on: 2022-03-31

Participant Flow

The study enrolled a total of 8 subjects at 3 investigation sites. Of which seven subjects were diagnosed with Essential Tremor and one subject with Parkinson's Disease. The first subject enrollment was on June 26, 2019.

Participant milestones

Measure	Single Arm Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Overall Study STARTED	8
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Single Arm n=8 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Age, Continuous	64 years STANDARD_DEVIATION 9 • n=8 Participants
Sex: Female, Male Female	4 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=8 Participants
Region of Enrollment United States	8 participants n=8 Participants
Essential Tremor	7 Participants n=8 Participants
Parkinson's Disease	1 Participants n=8 Participants
Years of essential tremor symptoms	26 years STANDARD_DEVIATION 16 • n=7 Participants • Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease.
Years since initial diagnosis of essential tremor	16 years STANDARD_DEVIATION 10 • n=7 Participants • Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease.

PRIMARY outcome

Timeframe: At Day 21 compared to baseline

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

Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.

Outcome measures

Measure	Single Arm n=8 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline Baseline	1.37 milliampere (mA) Standard Deviation 1.48
Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline Informity Programming	1.80 milliampere (mA) Standard Deviation 1.35

PRIMARY outcome

Timeframe: At Day 21 compared to baseline

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

Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.

Outcome measures

Measure	Single Arm n=8 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline Informity Programming	2.34 milliampere (mA) Standard Deviation 1.29
Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline Baseline	1.37 milliampere (mA) Standard Deviation 1.48

PRIMARY outcome

Timeframe: At Day 21 compared to baseline

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

TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.

Outcome measures

Measure	Single Arm n=8 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline Baseline	46.6 microjoule (μJ) Standard Deviation 30.2
Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline Informity Programming	65.6 microjoule (μJ) Standard Deviation 94.5

PRIMARY outcome

Timeframe: At Day 21 compared to baseline

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

TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.

Outcome measures

Measure	Single Arm n=8 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline Baseline	46.6 microjoule (μJ) Standard Deviation 30.2
Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline Informity Programming	31.4 microjoule (μJ) Standard Deviation 23.9

SECONDARY outcome

Timeframe: At 3 months compared to baseline

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

Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.

Outcome measures

Measure	Single Arm n=5 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months Baseline	20.6 score on a scale Standard Deviation 9.8
Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months 3 months	19.6 score on a scale Standard Deviation 7.8

SECONDARY outcome

Timeframe: At 6 months compared to baseline

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

Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.

Outcome measures

Measure	Single Arm n=5 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months 6 months	18.2 score on a scale Standard Deviation 10.2
Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months Baseline	20.6 score on a scale Standard Deviation 9.8

SECONDARY outcome

Timeframe: At baseline

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

Mean quality of life will be measured by the QUEST for ET subjects at baseline. 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. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Single Arm n=7 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline Communication	7 score on a scale Standard Deviation 13
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline Work / Finance	17 score on a scale Standard Deviation 23
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline Hobbies / Leisure	35 score on a scale Standard Deviation 35
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline Physical	36 score on a scale Standard Deviation 22
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline Psychosocial	24 score on a scale Standard Deviation 14

SECONDARY outcome

Timeframe: At 3 months

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

Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. 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. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Single Arm n=7 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months Communication	19 score on a scale Standard Deviation 11
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months Work / Finance	14 score on a scale Standard Deviation 24
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months Hobbies / Leisure	25 score on a scale Standard Deviation 31
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months Physical	28 score on a scale Standard Deviation 20
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months Psychosocial	12 score on a scale Standard Deviation 8

SECONDARY outcome

Timeframe: At 6 months

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

Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. 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. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.

Outcome measures

Measure	Single Arm n=7 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months Communication	15 score on a scale Standard Deviation 13
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months Work / Finance	5 score on a scale Standard Deviation 14
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months Hobbies / Leisure	20 score on a scale Standard Deviation 32
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months Physical	41 score on a scale Standard Deviation 26
Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months Psychosocial	13 score on a scale Standard Deviation 12

SECONDARY outcome

Timeframe: At Day 21

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

Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment

Outcome measures

Measure	Single Arm n=7 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Mean Duration of Programming Last programming session	76 minutes Standard Deviation 70
Mean Duration of Programming Informity programming session	85 minutes Standard Deviation 37

SECONDARY outcome

Timeframe: At 3 months compared to baseline

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

Change in TEED at the 3-month follow-up visit compared to baseline

Outcome measures

Measure	Single Arm n=7 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months Baseline	44.8 milliampere (mA) Standard Deviation 32.7
Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months 3 months	75.1 milliampere (mA) Standard Deviation 70.1

SECONDARY outcome

Timeframe: At 6 months compared to baseline

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

Change in TEED at the 6-month follow-up visit compared to baseline

Outcome measures

Measure	Single Arm n=7 Participants Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months Baseline	44.8 milliampere (mA) Standard Deviation 32.7
Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months 6 months	76.0 milliampere (mA) Standard Deviation 75.0

Adverse Events

Single Arm

Serious events: 2 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	Single Arm n=8 participants at risk Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Musculoskeletal and connective tissue disorders Spine fracture	12.5% 1/8 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Extension malfunction	12.5% 1/8 • Number of events 1 • 6 months

Other adverse events

Measure	Single Arm n=8 participants at risk Clinician programmer electrode screening mode tool Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
Injury, poisoning and procedural complications Persistent pain, tightness, or discomfort around the implanted parts	12.5% 1/8 • Number of events 1 • 6 months
Injury, poisoning and procedural complications Initial jolt, or tingling stimulation	12.5% 1/8 • Number of events 1 • 6 months

Additional Information

Binith Cheeran

Abbott Medical Devices Neuromodulation

Phone: +15122864262

Email: binith.cheeran@abbott.com

Results disclosure agreements

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

Restriction type: OTHER