Trial Outcomes & Findings for Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease (NCT NCT05753449)

Last Updated: 2025-05-28

Results Overview

This outcome is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state, after the first treatment (administered for 30 minutes) and after the second treatment (administered for 30 minutes). For example, the first treatment for patients in the arm "Baseline Programming First, Then Experimental Burst-type Programming" was baseline (or standard of care) DBS programming, and the second treatment was experimental Burst-style programming. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score indicates a worse outcome.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

Baseline

Results posted on

2025-05-28

Participant Flow

2 subjects were recruited in the medical clinic between August 24, 2022, and February 21, 2024. Recruitment ended as we encountered significant challenges in recruiting participants for the study finding reluctance of patients who have achieved successful outcomes with their deep brain stimulation (DBS) devices to participate. They are understandably hesitant to risk potential symptom worsening by altering their device settings, even for the purpose of research.

Participant milestones

Participant milestones
Measure	Baseline Programming First, Then Experimental Burst-type Programming In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.	Experimental Burst-type Programming First, Then Baseline Programming In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.
Visit 1: First Treatment (30 Min) STARTED	0	2
Visit 1: First Treatment (30 Min) COMPLETED	0	2
Visit 1: First Treatment (30 Min) NOT COMPLETED	0	0
Visit 1: Washout Period (15 Min) STARTED	0	2
Visit 1: Washout Period (15 Min) COMPLETED	0	2
Visit 1: Washout Period (15 Min) NOT COMPLETED	0	0
Visit 1: Second Treatment (30 Min) STARTED	0	2
Visit 1: Second Treatment (30 Min) COMPLETED	0	2
Visit 1: Second Treatment (30 Min) NOT COMPLETED	0	0
Visit 2: Burst-type Programming (30 Min) STARTED	0	1
Visit 2: Burst-type Programming (30 Min) COMPLETED	0	1
Visit 2: Burst-type Programming (30 Min) NOT COMPLETED	0	0
Visit 3: Burst-type Programming (30 Min) STARTED	0	1
Visit 3: Burst-type Programming (30 Min) COMPLETED	0	1
Visit 3: Burst-type Programming (30 Min) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Burst-Type Deep Brain Stimulation of the Subthalamic Nucleus in Parkinson's Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Baseline Programming First, Then Experimental Burst-type Programming In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.	Experimental Burst-type Programming First, Then Baseline Programming n=2 Participants In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Age, Continuous	—	70 years n=7 Participants	70 years n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	—	2 participants n=7 Participants	2 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: No subjects were randomized to the arm that received baseline (standard of care) programming first, followed by experimental Burst-style programming (at Visit 1).

Outcome measures

Outcome measures
Measure	Baseline Programming First, Then Experimental Burst-type Programming In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.	Experimental Burst-type Programming First, Then Baseline Programming n=2 Participants In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.
Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1) Second Treatment / Programming Setting	—	32 score on a scale Interval 22.0 to 42.0
Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1) Medication-Off and DBS-Off State	—	55.5 score on a scale Interval 33.0 to 78.0
Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Baseline (Visit 1) First Treatment / Programming Setting	—	20 score on a scale Interval 18.0 to 22.0

PRIMARY outcome

Timeframe: 6 months

Population: No subjects were randomized to the arm that received baseline (standard of care) programming first, followed by experimental Burst-style programming (at Visit 1). Follow-up data at six months (Visit 2) were only available for one of the two patients randomized to first be treated with the experimental Burst-type programming at Visit 1. Additionally, data were not collected in the Medication Off state for the patient for whom there are follow-up data at six months (Visit 2).

This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at six months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2).

Outcome measures

Outcome measures
Measure	Baseline Programming First, Then Experimental Burst-type Programming In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.	Experimental Burst-type Programming First, Then Baseline Programming n=1 Participants In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.
Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Six Months (Visit 2) Burst-type Programming	—	25 score on a scale Interval 25.0 to 25.0

PRIMARY outcome

Timeframe: 12 months

Population: No subjects were randomized to the arm that received baseline (standard of care) programming first, followed by experimental Burst-style programming (at Visit 1). Follow-up data at 12 months were only available for one of the two patients randomized to first be treated with the experimental Burst-type programming at Visit 1. Additionally, data were not collected in the Medication Off state for the patient for whom there are follow-up data at six months (Visit 2).

This outcomes is the Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Score in the "Medication Off" state and after burst-type DBS programming in the acute setting (after 30 minutes) at 12 months. Each item is scored on a scale from 0 (normal) to 4 (severe, marked, or unable), with the total possible score for the 14 items, including separate questions regarding symptoms present axially and in appendages, ranging from 0 to 108. A higher score means a worse outcome. Note that the study arm titles refer to whether or not the patients were randomized to baseline programming or Burst-type programming at Visit 1. During this visit (Visit 2), all study subjects were to be evaluated in the medication-off state and then evaluated following 30 minutes of treatment with Burst-type programming. Treatment with baseline programming was not administered during this visit (Visit 2).

Outcome measures

Outcome measures
Measure	Baseline Programming First, Then Experimental Burst-type Programming In this arm, patients were randomized to initially receive treatment with baseline DBS programming (standard of care) at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then experimental Burst-type programming for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming.	Experimental Burst-type Programming First, Then Baseline Programming n=1 Participants In this arm, patients were randomized to initially receive treatment with experimental Burst-type DBS programming at Visit 1. After a 30 minute treatment period, patients were to undergo UPDRS III evaluation, a 15 minute washout period with the DBS turned off and then baseline programming (standard of care) for 30 minutes. Finally, patients were to undergo UPDRS III evaluation after the second round of programming. Burst-type DBS is defined as a novel stimulation protocol in which intermittent bursts of traditional high-frequency rectangular wave stimulation are delivered.
Unified Parkinson's Disease Rating Scale (UPDRS) v-III Motor Examination Scores at Twelve Months (Visit 3) Burst-type Programming	—	26 score on a scale Interval 26.0 to 26.0

Adverse Events

Baseline Programming First, Then Experimental Burst-type Programming (at Visit 1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Experimental Burst-type Programming First, Then Baseline Programming (at Visit 1)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Megan Hendricks, regulatory Specialist

Allegheny Health Network

Phone: 412-330-6206

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place