Trial Outcomes & Findings for Biomarkers to Guide Directional DBS for Parkinson's Disease (NCT NCT03353688)
NCT ID: NCT03353688
Last Updated: 2024-09-19
Results Overview
A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
COMPLETED
NA
31 participants
2, 4, and 6 months post op
2024-09-19
Participant Flow
Participant milestones
| Measure |
Directional DBS by Behavior; Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last
Participants were randomly assigned to directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments. Next they were assigned to omnidirectional stimulation based on behavior. Finally, they were assigned to directional DBS based on biomarkers recorded in surgery.
First Intervention (2 months), Second Intervention (2 months), and Third Intervention (2 months).
|
Omnidirectional DBS by Behavior; Directional DBS by Behavior; Directional DBS by Biomarkers Last
Participants were randomly assigned to omnidirectional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments. Next they were assigned to directional stimulation based on behavior. Finally, they were assigned to directional DBS based on biomarkers recorded in surgery.
First Intervention (2 months), Second Intervention (2 months), and Third Intervention (2 months).
|
Either Directional DBS or Omnidirectional DBS by Behavior; Directional DBS by Biomarkers Last
Upon completion of the first two periods (either directional stimulation or omnidirectional stimulation based on behavioral assessments), all participants were assigned to a directional unilateral subthalamic stimulation strategy with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
First Intervention (2 months), Second Intervention (2 months), and Third Intervention (2 months).
|
|---|---|---|---|
|
First Intervention (2 Months)
STARTED
|
17
|
14
|
0
|
|
First Intervention (2 Months)
COMPLETED
|
17
|
14
|
0
|
|
First Intervention (2 Months)
NOT COMPLETED
|
0
|
0
|
0
|
|
Second Intervention (2 Months)
STARTED
|
14
|
17
|
0
|
|
Second Intervention (2 Months)
COMPLETED
|
14
|
17
|
0
|
|
Second Intervention (2 Months)
NOT COMPLETED
|
0
|
0
|
0
|
|
Third Intervention (2 Months)
STARTED
|
0
|
0
|
31
|
|
Third Intervention (2 Months)
COMPLETED
|
0
|
0
|
31
|
|
Third Intervention (2 Months)
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Biomarkers to Guide Directional DBS for Parkinson's Disease
Baseline characteristics by cohort
| Measure |
All Study Participants
n=31 Participants
Aggregate baseline data for all study participants
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
58.85 years
STANDARD_DEVIATION 7.60 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
31 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
A blinded examiner will measure Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 motor scores "off" medications. MDS-UPDRS Part III is a motor examination consisting of 18 summed items where the investigator rates the severity of Parkinson's motor symptoms based on a scale of 0 - 4. Higher values indicate worse function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS Part III) "Off" Medications
|
-18.33333333 change from baseline units on a scale
Standard Deviation 9.848274252
|
-16.90322581 change from baseline units on a scale
Standard Deviation 9.253305135
|
-15.80645161 change from baseline units on a scale
Standard Deviation 9.257139064
|
PRIMARY outcome
Timeframe: 4 months post surgeryPopulation: All participants experienced all three arms of the crossover study.
Based on overall quality of life, participants will select their preference between directional and omnidirectional DBS.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=30 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=30 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Treatment Preference Survey Programming Strategy Preference
|
—
|
16 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Beck Depression Inventory-2 is a 21 question self-report inventory which evaluates a person's severity of depression. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Beck Depression Inventory-2 (BDI-2)
|
0.692307692 change from baseline units on a scale
Standard Deviation 6.739550316
|
0.965517241 change from baseline units on a scale
Standard Deviation 6.455798936
|
1.032258065 change from baseline units on a scale
Standard Deviation 5.056242814
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Beck Anxiety Inventory is a 21 question self-report inventory which evaluates a person's severity of anxiety. Items are answered on a 0 - 3 scale. Higher values indicate worse function (possible min score = 0, possible max score = 63). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Beck Anxiety Inventory (BAI)
|
-0.6875 change from baseline units on a scale
Standard Deviation 8.16266909
|
-2.55 change from baseline units on a scale
Standard Deviation 5.689093906
|
-0.333333333 change from baseline units on a scale
Standard Deviation 6.32455532
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Auditory Verbal Learning Test (AVLT) delayed recall raw score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and later asked to recall the items on the list. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 12). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Delayed Recall Raw Score (Versions AB, CD, CR, GE)
|
-0.461538462 change from baseline units on a scale
Standard Deviation 3.776037809
|
-0.866666667 change from baseline units on a scale
Standard Deviation 3.785027976
|
-0.9 change from baseline units on a scale
Standard Deviation 3.39726056
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Auditory Verbal Learning Test (AVLT) Recognition Raw Score (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are given a list of 15 target words. The list is taken away and each is asked to now pick out the 15 target words from a larger list of 30 words. Scores indicate the overall number of target words correctly recognized (minimum = 0, maximum = 15). Higher scores indicate better performance. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Recognition Raw Score (Versions AB, CD, CR, GE)
|
-0.961538462 change from baseline units on a scale
Standard Deviation 1.482720991
|
-0.5 change from baseline units on a scale
Standard Deviation 1.696853071
|
-0.433333333 change from baseline units on a scale
Standard Deviation 1.59056124
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The AVLT (versions AB, CD, CR, GE) evaluates a person's ability to encode, consolidate, store, and retrieve verbal information. Participants are read a list of 12 words and asked to immediately recall the items on the list over 6 separate trials. Scores indicate the number of items recalled. Higher values indicate better function (possible min score = 0, possible max score = 72). A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Auditory Verbal Learning Test (AVLT) Learning Raw Score (Versions AB, CD, CR, GE)
|
-0.576923077 change from baseline units on a scale
Standard Deviation 8.276100903
|
-2.233333333 change from baseline units on a scale
Standard Deviation 9.772174901
|
-3.3 change from baseline units on a scale
Standard Deviation 9.203260292
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Letter Fluency Test (version: CFL, FAS) evaluates the number of words beginning with the letters C, F, L, A, and S that a participant can produce in one minute (minimum = 0, maximum = infinity). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Letter Fluency Test Raw Score (Version: CFL, FAS)
|
-1.230769231 words generated
Standard Deviation 9.074393389
|
-1.766666667 words generated
Standard Deviation 8.21975473
|
-1.935483871 words generated
Standard Deviation 9.401898687
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Voice Handicap Index evaluates speech function with a 30-item self-administered questionnaire that asks participants to describe their voice and the effects of their voice on their lives. Participants respond on a 0 - 4 scale (minimum = 0, maximum = 120. Higher scores indicate worse functiion. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Voice Handicap Index
|
-0.925925926 change from baseline units on a scale
Standard Deviation 12.04135798
|
-2.709677419 change from baseline units on a scale
Standard Deviation 9.256325939
|
0.225806452 change from baseline units on a scale
Standard Deviation 7.774786931
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Communicative Participation Item Bank (CPIB) evaluates the extent to which communication disorders interfere with communicative participation. Participants respond on a 0 - 3 scale (minimum = 0, maximum = 30). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Communicative Participation Item Bank (CPIB)
|
-0.740740741 change from baseline units on a scale
Standard Deviation 4.927103944
|
-0.387096774 change from baseline units on a scale
Standard Deviation 3.489769996
|
-0.741935484 change from baseline units on a scale
Standard Deviation 2.920818857
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The 9-Hole Pegboard Test evaluates one's upper extremity motor function. It is a timed test in which participants place 9 pegs in a pegboard and then remove them. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the 9-Hole Pegboard Test
|
-6.755 time (seconds)
Standard Deviation 11.38578962
|
-6.15 time (seconds)
Standard Deviation 10.86369404
|
-5.242258065 time (seconds)
Standard Deviation 11.16955019
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The gait initiation test evaluates the phase between standing motionless and steady-state locomotion. This is a timed test in which participants are given a go signal and the time until first stride is recorded. Faster times indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Gait Initiation Test
|
2.282 time (seconds)
Standard Deviation 27.67356219
|
5.810333333 time (seconds)
Standard Deviation 22.17604991
|
2.491 time (seconds)
Standard Deviation 22.48954996
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The stepping thresholds test evaluates a person's compensatory stepping thresholds. This is a test in which the floor surface is unexpectedly moved beneath a participant. The distance a participant moves their feet in order to compensate is recorded. The smaller displacement scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Stepping Thresholds Test
|
0.603448276 mm displacement
Standard Deviation 0.76039593
|
0.616666667 mm displacement
Standard Deviation 0.762067665
|
0.583333333 mm displacement
Standard Deviation 0.732065257
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The quiet stance measure evaluates a person's postural control during quiet standing. This is a measure of sway distance. Lower scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Quiet Stance Measure
|
-65.52133333 change from baseline mm sway
Standard Deviation 966.9356483
|
-243.7980645 change from baseline mm sway
Standard Deviation 746.4082743
|
-50.747 change from baseline mm sway
Standard Deviation 819.179683
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Parkinson's Disease Quality of Life (PDQ-8) evaluates overall health status. It consists of eight questions regarding mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication, and bodily discomfort. Participants choose answers on a scale ranging from never (0) to always (4) (minimum = 0, maximum = 32). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Parkinson's Disease Quality of Life
|
-7.924615385 change from baseline units on a scale
Standard Deviation 14.85058274
|
-5.756833333 change from baseline units on a scale
Standard Deviation 11.44863367
|
-6.274655172 change from baseline units on a scale
Standard Deviation 12.96997528
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form evaluates feelings that reflect a level of general satisfaction with life as well as a sense that life has purpose and meaning. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the the Neuro-QOL Item Bank v1.0 "Positive Affect and Well-Being" Short Form
|
0.04 change from baseline units on a scale
Standard Deviation 3.469870315
|
1.321428571 change from baseline units on a scale
Standard Deviation 5.34064479
|
0.1 change from baseline units on a scale
Standard Deviation 5.652890625
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Item Bank v1.1 "Satisfaction with Social Roles and Activities" short form short form evaluates one's satisfaction and discontentment with performing usual social roles and activities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.1 "Satisfaction With Social Roles and Activities" Short Form
|
1.24 change from baseline units on a scale
Standard Deviation 4.064890322
|
2.142857143 change from baseline units on a scale
Standard Deviation 4.352217704
|
3.586206897 change from baseline units on a scale
Standard Deviation 4.917296305
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Item Bank v2.0 ""Cognitive Function" short form evaluates mental acuity, concentration, verbal and nonverbal memory, verbal fluency, and perceived changes in these cognitive functions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Item Bank v2.0 "Cognitive Function" Short Form
|
2.72 change from baseline units on a scale
Standard Deviation 6.045108215
|
3.821428571 change from baseline units on a scale
Standard Deviation 4.83853032
|
3.333333333 change from baseline units on a scale
Standard Deviation 5.234720513
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" short form evaluates functioning of one's lower extremities. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Lower Extremity Function (Mobility)" Short Form
|
-0.48 change from baseline units on a scale
Standard Deviation 5.393823628
|
0.678571429 change from baseline units on a scale
Standard Deviation 4.172694053
|
1.333333333 change from baseline units on a scale
Standard Deviation 5.280630405
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" short form evaluates functioning of one's upper extremity function in fine motor and ADL capabilities. Participants respond to questions on a 1-5 scale (minimum = 9, maximum = 45). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Upper Extremity Function (Fine Motor, ADL)" Short Form
|
1.76 change from baseline units on a scale
Standard Deviation 5.532329226
|
2.392857143 change from baseline units on a scale
Standard Deviation 5.573344536
|
3.896551724 change from baseline units on a scale
Standard Deviation 6.635105918
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Item Bank v1.0 "Stigma" short form evaluates one's sensitivity of illness-related stigma. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Stigma" Short Form
|
-1.76 change from baseline units on a scale
Standard Deviation 6.022734706
|
-2.107142857 change from baseline units on a scale
Standard Deviation 4.755809591
|
-2.333333333 change from baseline units on a scale
Standard Deviation 6.143869012
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The Neuro-QOL Scale v1.0 "Communication" short form evaluates one's difficulty with communication. Participants respond to questions on a 1-5 scale (minimum = 5, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Scale v1.0 "Communication" Short Form
|
2.6 change from baseline units on a scale
Standard Deviation 14.29743567
|
0.535714286 change from baseline units on a scale
Standard Deviation 12.79028029
|
1.633333333 change from baseline units on a scale
Standard Deviation 10.9559725
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" short form evaluates one's confidence to manage/control symptoms of frustration, disappointment, anger, and other negative emotions. Participants respond to questions on a 1-5 scale (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Neuro-QOL Item Bank v1.0 "Emotional and Behavioral Dyscontrol" Short Form
|
-0.76 change from baseline units on a scale
Standard Deviation 7.44020609
|
-1.142857143 change from baseline units on a scale
Standard Deviation 7.158079019
|
0.133333333 change from baseline units on a scale
Standard Deviation 5.667410364
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v1.0 "Global Health" short form evaluates the individual's global health. This is a 10 question scale on which 9 of the questions are answered with a 1 - 5 score. The remaining item is answered with a 0 - 10 score. (minimum = 9, maximum = 55). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Global Health" Short Form
|
0.375 change from baseline units on a scale
Standard Deviation 4.604463808
|
1.5 change from baseline units on a scale
Standard Deviation 5.763872155
|
0.433333333 change from baseline units on a scale
Standard Deviation 4.546186984
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The (PROMIS) Scale v1.2 "Global Health" evaluates one's overall physical and mental health. This is a 10 item scale with scores ranging from 4-20. Higher scores indicate better overall health. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.2 "Global Health Mental Health Score"
|
3.166666667 change from baseline units on a scale
Standard Deviation 7.590993901
|
2.607142857 change from baseline units on a scale
Standard Deviation 5.983553297
|
-0.5 change from baseline units on a scale
Standard Deviation 6.730015115
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v2.0 "Ability to Participate in Social Roles and Activities" short form evaluates one's perceived ability to perform one's usual social roles and activities. This is an 8 question measure and answers are given on a 1 - 5 scale (minimum = 8, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Ability to Participate in Social Roles and Activities" Short Form
|
2.333333333 change from baseline units on a scale
Standard Deviation 5.121707143
|
1.230769231 change from baseline units on a scale
Standard Deviation 5.666093485
|
1.24137931 change from baseline units on a scale
Standard Deviation 5.717486788
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v1.0 "Emotional Distress - Anxiety" short form evaluates one's feelings of anxiety, such as fear and worry. This is a 7 item scale and participants answer with a 1 - 5 score for each item (minimum = 7, maximum = 35). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Anxiety" Short Form
|
-2.333333333 change from baseline units on a scale
Standard Deviation 6.598199139
|
-2.178571429 change from baseline units on a scale
Standard Deviation 5.192969403
|
-0.7 change from baseline units on a scale
Standard Deviation 5.802199345
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v1.0 "Emotional Distress - Depression" short form evaluates one's feelings of negative mood and depression. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Emotional Distress - Depression" Short Form
|
-1.541666667 change from baseline units on a scale
Standard Deviation 7.052468989
|
-1.071428571 change from baseline units on a scale
Standard Deviation 4.126953602
|
-0.533333333 change from baseline units on a scale
Standard Deviation 4.987801211
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v1.0 "Fatigue" short form evaluates one's range of symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Fatigue" Short Form
|
-2.173913043 change from baseline units on a scale
Standard Deviation 7.088096128
|
-3.25 change from baseline units on a scale
Standard Deviation 6.304760106
|
-1.933333333 change from baseline units on a scale
Standard Deviation 6.766720457
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v2.0 "Physical Function" short form measures self-reported capability rather than actual performance of physical activities. This is a 10 item scale and participants answer with a 1 - 5 score for each item (minimum = 10, maximum = 50). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v2.0 "Physical Function" Short Form
|
0.652173913 change from baseline units on a scale
Standard Deviation 3.926699929
|
1.964285714 change from baseline units on a scale
Standard Deviation 3.666486287
|
1.724137931 change from baseline units on a scale
Standard Deviation 3.99013562
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v1.0 "Pain Interference" short form evaluates the consequences of pain on relevant aspects of one's life. This includes the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. This is a 6 item scale and participants answer with a 1 - 5 score for each item (minimum = 6, maximum = 30). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement
|
-2.818181818 change from baseline units on a scale
Standard Deviation 7.768289409
|
-1.75 change from baseline units on a scale
Standard Deviation 6.304760106
|
-2.275862069 change from baseline units on a scale
Standard Deviation 7.372228543
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The PROMIS v1.0 "Sleep Disturbance" short form evaluates one's perceptions of sleep quality. This is an 8 item scale and participants answer with a 1 - 5 score for each item (minimum = 8, maximum = 40). Higher scores indicate worse function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in Patient-Reported Outcomes Measurement Information System PROMIS v1.0 "Sleep Disturbance" Short Form
|
-3.739130435 change from baseline units on a scale
Standard Deviation 4.673108672
|
-2.592592593 change from baseline units on a scale
Standard Deviation 7.781928075
|
-3.965517241 change from baseline units on a scale
Standard Deviation 8.042222324
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. On this test participants are asked to match pictures to a category and receive one point for each correct match (minimum = 0, maximum = 40). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Dimensional Change Card Sort Score
|
3 change from baseline units on a scale
Standard Deviation 7.874007874
|
0.210526316 change from baseline units on a scale
Standard Deviation 14.11688881
|
0.473684211 change from baseline units on a scale
Standard Deviation 7.47862451
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The Flanker Test is a test in which participants are asked to focus on a particular stimulus while inhibiting attention to another. An accuracy score is derived by calculating (Accuracy Score = 0.125 \* Number of Correct Responses) (minimum=0, maximum=5). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Flanker Test Score
|
2.3125 accuracy score
Standard Deviation 5.134442521
|
2.263157895 accuracy score
Standard Deviation 8.15026997
|
3.526315789 accuracy score
Standard Deviation 4.562752837
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The list sorting working memory test is a test in which lists of items are presented and participants are asked to recall items from the list in a particular order. Scoring is done based on the number of items correctly recalled and sequenced (minimum = 0, maximum = 26). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery List Sorting Working Memory Test Score
|
-1.3125 change from baseline units on a scale
Standard Deviation 10.2613758
|
-0.947368421 change from baseline units on a scale
Standard Deviation 9.553787406
|
0.526315789 change from baseline units on a scale
Standard Deviation 11.15232124
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The oral reading recognition test is a test in which participants are asked to read and pronounce words as accurately as possible. Pronunciation is judged by the test administrator and a score is given to each response (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Oral Reading Test Score
|
-3.25 words/letters correctly pronounced
Standard Deviation 5.272570531
|
-1.578947368 words/letters correctly pronounced
Standard Deviation 6.890539323
|
-1.894736842 words/letters correctly pronounced
Standard Deviation 5.867942445
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The pattern comparison test is a test in which participants are presented with two pictures and are asked to discern whether they are he same or different. Correct answers are given one point for up to a maximum of 130 trials (minimum = 0, maximum = 130). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Pattern Comparison Test Score
|
2.8125 units on a scale
Standard Deviation 14.27920983
|
1.421052632 units on a scale
Standard Deviation 11.19680406
|
3.526315789 units on a scale
Standard Deviation 13.61114095
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The picture sequencing test is a test of episodic memory in which participants are asked to recall increasingly lengthy series of illustrated objects and activities that are presented in a particular order on a computer screen. Participants are given credit for each adjacent pair of pictures they correctly place up to the maximum value for the sequence, which is one less than the sequence length (minimum = 0, maximum = 105). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Sequencing Test Score
|
2.875 number of correct sequences identified
Standard Deviation 8.891006692
|
1.842105263 number of correct sequences identified
Standard Deviation 13.22146049
|
4.263157895 number of correct sequences identified
Standard Deviation 10.09863635
|
SECONDARY outcome
Timeframe: 2, 4, and 6 months post opPopulation: All participants experienced all three arms of the crossover study.
The NIH Toolbox Cognition Battery evaluates cognitive function with Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, List Sorting Working Memory Test, Picture Vocabulary Test, Pattern Comparison Processing Speed Test, Picture Sequence Memory Test, and Oral Reading Recognition. The picture vocabulary test is a test in which participants are presented with an audio recording of a word and four photographic images on the computer screen and asked to select the picture that most closely matches the meaning of the word (minimum = 0, maximum = 25). Higher scores indicate better function. A change between baseline and performance at 2, 4, and 6 months post surgery is reported here. Score calculation is baseline - performance while on directional DBS guided by behavior, baseline - performance while on omnidirectional DBS guided by behavior, and baseline - performance while on directional DBS guided by biomarkers.
Outcome measures
| Measure |
Directional DBS Guided by Biomarkers
n=31 Participants
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Behavior
n=31 Participants
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 Participants
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Change From Preoperative Baseline in NIH Toolbox Cognition Battery Picture Vocabulary Test Score
|
-1.0625 number of correct matches
Standard Deviation 5.93822364
|
-1.105263158 number of correct matches
Standard Deviation 5.205709866
|
-0.578947368 number of correct matches
Standard Deviation 5.480427695
|
Adverse Events
Directional DBS Guided by Behavior
Omnidirectional DBS Guided by Behavior
Directional DBS Guided by Biomarkers
Serious adverse events
| Measure |
Directional DBS Guided by Behavior
n=31 participants at risk
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 participants at risk
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Biomarkers
n=31 participants at risk
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Cardiac disorders
SAE1
|
0.00%
0/31 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Surgical and medical procedures
SAE2
|
3.2%
1/31 • Number of events 1 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Nervous system disorders
SAE3
|
0.00%
0/31 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
|
Psychiatric disorders
SAE4
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
0.00%
0/31 • 1 year
|
|
Product Issues
SAE5
|
3.2%
1/31 • Number of events 1 • 1 year
|
3.2%
1/31 • Number of events 1 • 1 year
|
0.00%
0/31 • 1 year
|
Other adverse events
| Measure |
Directional DBS Guided by Behavior
n=31 participants at risk
Directional stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Omnidirectional DBS Guided by Behavior
n=31 participants at risk
Omnidirectional ("ring mode") stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by behavioral assessments during device activation.
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
Directional DBS Guided by Biomarkers
n=31 participants at risk
Directional unilateral subthalamic stimulation with the Boston Scientific Vercise PC IPG with directional DBS lead, guided by electrophysiology biomarkers measured during surgery (nested exploratory treatment arm).
Boston Scientific Vercise PC IPG with directional DBS lead: Deep brain stimulation
|
|---|---|---|---|
|
Product Issues
AE1
|
6.5%
2/31 • Number of events 2 • 1 year
|
0.00%
0/31 • 1 year
|
0.00%
0/31 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place