Trial Outcomes & Findings for Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (NCT NCT04547712)
NCT ID: NCT04547712
Last Updated: 2025-07-08
Results Overview
In the PD Home Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The PD Home Diary was collected at both the cDBS Baseline and aDBS Evaluation Phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
85 participants
Primary outcome timeframe
About one month
Results posted on
2025-07-08
Participant Flow
85 subjects were enrolled between December 14, 2020 and July 29, 2022 at 12 centers located in the US, Europe, and Canada. Out of these 85 subjects, 68 were in Primary Cohort and 17 in Directional Stimulation Cohort.
60 out of 85 subjects entered into the aDBS Evaluation Phase of the study. Of those 25 who didn't enter into the aDBS Evaluation Phase, 1 had inclusion/exclusion screen failure, 12 LFP screen failures, 4 physician decisions, and 8 subject decisions.
Participant milestones
| Measure |
Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received Single Threshold evaluation for about one month first, then Dual Threshold evaluation for about one month.
|
Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received Dual Threshold evaluation for about one month first, then Single Threshold evaluation for about one month.
|
Primary Cohort, One Mode: aDBS Single Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received only Single Threshold evaluation for about one month.
|
Primary Cohort, One Mode: aDBS Dual Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received only Dual Threshold evaluation for about one month.
|
Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode
This cohort comprised of study subjects with SenSight™ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
|
Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode
This cohort comprised of study subjects with SenSight™ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
|
Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
This cohort comprised of study subjects with SenSight™ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
|
|---|---|---|---|---|---|---|---|
|
cDBS Baseline (~ 30 Days)
STARTED
|
16
|
14
|
5
|
10
|
6
|
7
|
2
|
|
cDBS Baseline (~ 30 Days)
COMPLETED
|
16
|
14
|
5
|
10
|
6
|
7
|
2
|
|
cDBS Baseline (~ 30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
aDBS Setup & Adjustment (up to 65 Days)
STARTED
|
16
|
14
|
5
|
10
|
6
|
7
|
2
|
|
aDBS Setup & Adjustment (up to 65 Days)
COMPLETED
|
16
|
14
|
5
|
10
|
6
|
7
|
2
|
|
aDBS Setup & Adjustment (up to 65 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Crossover: 1st Intervention (~ 30 Days)
STARTED
|
16
|
14
|
0
|
0
|
6
|
7
|
0
|
|
Crossover: 1st Intervention (~ 30 Days)
COMPLETED
|
16
|
14
|
0
|
0
|
6
|
7
|
0
|
|
Crossover: 1st Intervention (~ 30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Crossover: 2nd Intervention (~ 30 Days)
STARTED
|
16
|
14
|
0
|
0
|
6
|
7
|
0
|
|
Crossover: 2nd Intervention (~ 30 Days)
COMPLETED
|
16
|
14
|
0
|
0
|
6
|
7
|
0
|
|
Crossover: 2nd Intervention (~ 30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
One Mode: Single Threshold (~ 30 Days)
STARTED
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
One Mode: Single Threshold (~ 30 Days)
COMPLETED
|
0
|
0
|
5
|
0
|
0
|
0
|
0
|
|
One Mode: Single Threshold (~ 30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
|
One Mode: Dual Threshold (~ 30 Days)
STARTED
|
0
|
0
|
0
|
10
|
0
|
0
|
2
|
|
One Mode: Dual Threshold (~ 30 Days)
COMPLETED
|
0
|
0
|
0
|
10
|
0
|
0
|
0
|
|
One Mode: Dual Threshold (~ 30 Days)
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Baseline characteristics by cohort
| Measure |
Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode
n=16 Participants
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received Single Threshold evaluation for about one month first, then Dual Threshold evaluation for about one month.
|
Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode
n=14 Participants
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received Dual Threshold evaluation for about one month first, then Single Threshold evaluation for about one month.
|
Primary Cohort, One Mode: aDBS Single Threshold Mode
n=5 Participants
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received only Single Threshold evaluation for about one month.
|
Primary Cohort, One Mode: aDBS Dual Threshold Mode
n=10 Participants
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSight™ lead model B33005 or B33015 programmed to ring mode stimulation, received only Dual Threshold evaluation for about one month.
|
Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode
n=6 Participants
This cohort comprised of study subjects with SenSight™ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
|
Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode
n=7 Participants
This cohort comprised of study subjects with SenSight™ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
|
Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
n=2 Participants
This cohort comprised of study subjects with SenSight™ lead model B33005 or B33015 programmed to directional stimulation, with Dual Threshold evaluation for about one month.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 9.49 • n=5 Participants
|
64.2 years
STANDARD_DEVIATION 7.62 • n=7 Participants
|
59.6 years
STANDARD_DEVIATION 7.16 • n=5 Participants
|
59.6 years
STANDARD_DEVIATION 10.08 • n=4 Participants
|
59.7 years
STANDARD_DEVIATION 4.18 • n=21 Participants
|
61.0 years
STANDARD_DEVIATION 8.08 • n=8 Participants
|
58.0 years
STANDARD_DEVIATION 2.83 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 8.15 • n=24 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
19 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
41 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
45 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=24 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
43 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
14 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
2 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
4 participants
n=24 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
1 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
6 participants
n=24 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
2 participants
n=5 Participants
|
7 participants
n=4 Participants
|
6 participants
n=21 Participants
|
7 participants
n=8 Participants
|
2 participants
n=8 Participants
|
48 participants
n=24 Participants
|
|
Region of Enrollment
France
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
2 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: About one monthPopulation: As pre-specified, the analysis population included only Primary Cohort subjects, following the intention-to-treat principle, who initiated the aDBS Evaluation Phase (including both randomized crossover subjects and one mode subjects). Analysis of the primary endpoint is based on the aDBS mode (Single or Dual Threshold) by pooling subjects from randomized crossover and one mode arms. As pre-specified, Directional Stimulation Cohort was not included in the primary objective analysis.
In the PD Home Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The PD Home Diary was collected at both the cDBS Baseline and aDBS Evaluation Phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
Outcome measures
| Measure |
Primary Cohort aDBS Single Threshold
n=35 Participants
Adaptive DBS Single Threshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
|
Primary Cohort aDBS Dual Threshold
n=40 Participants
Adaptive DBS DualThreshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
|
Primary Cohort: aDBS Dual Threshold Mode
Adaptive DBS Dual Threshold Mode, including subjects in Full Analysis Set who were either randomized to crossover periods or received one mode
|
|---|---|---|---|
|
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
|
78.9 percentage of participant
Interval 59.4 to
Pre-specified hypothesis testing was one-sided, the lower bound of the 97.5% confidence limit was determined using the MI Clopper-Pearson mean success approach, the upper bound was not calculated. So only the confidence interval lower bound is provided, the upper bound is NA.
|
91 percentage of participant
Interval 75.6 to
Pre-specified hypothesis testing was one-sided, the lower bound of the 97.5% confidence limit was determined using the MI Clopper-Pearson mean success approach, the upper bound was not calculated. So only the confidence interval lower bound is provided, the upper bound is NA.
|
—
|
SECONDARY outcome
Timeframe: About one monthPopulation: As pre-specified, the analysis population included only Primary Cohort subjects, following the intention-to-treat principle, who initiated the aDBS Evaluation Phase (including both randomized crossover subjects and one mode subjects). Analysis of the primary endpoint is based on the aDBS mode (Single or Dual Threshold) by pooling subjects from randomized crossover and one mode arms. As pre-specified, Directional Stimulation Cohort was not included in the secondary objective analysis.
Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.
Outcome measures
| Measure |
Primary Cohort aDBS Single Threshold
n=35 Participants
Adaptive DBS Single Threshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
|
Primary Cohort aDBS Dual Threshold
n=40 Participants
Adaptive DBS DualThreshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
|
Primary Cohort: aDBS Dual Threshold Mode
Adaptive DBS Dual Threshold Mode, including subjects in Full Analysis Set who were either randomized to crossover periods or received one mode
|
|---|---|---|---|
|
Stimulation Energy Use
|
-22.3 micro Watts
Interval -42.0 to -2.6
|
-22.3 micro Watts
Interval -48.0 to 3.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: About one monthPopulation: As pre-specified, the analysis population included only Primary Cohort subjects, following the intention-to-treat principle, who initiated the aDBS Evaluation Phase (including both randomized crossover subjects and one mode subjects). Analysis of the primary endpoint is based on the aDBS mode (Single or Dual Threshold) by pooling subjects from randomized crossover and one mode arms. As pre-specified, Directional Stimulation Cohort was not included in the analysis of this objective.
To characterize stimulation-related adverse events
Outcome measures
| Measure |
Primary Cohort aDBS Single Threshold
n=45 Participants
Adaptive DBS Single Threshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
|
Primary Cohort aDBS Dual Threshold
n=35 Participants
Adaptive DBS DualThreshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
|
Primary Cohort: aDBS Dual Threshold Mode
n=40 Participants
Adaptive DBS Dual Threshold Mode, including subjects in Full Analysis Set who were either randomized to crossover periods or received one mode
|
|---|---|---|---|
|
Safety (Stimulation-related AEs)
|
3 Participants
|
8 Participants
|
5 Participants
|
Adverse Events
Enrollment to Randomization
Serious events: 0 serious events
Other events: 32 other events
Deaths: 0 deaths
Primary Cohort aDBS Single Threshold Mode
Serious events: 1 serious events
Other events: 10 other events
Deaths: 1 deaths
Primary Cohort aDBS Dual Threshold Mode
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Directional Stimulation Cohort aDBS Single Threshold Mode
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Directional Stimulation Cohort aDBS Dual Threshold Mode
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Enrollment to Randomization
n=85 participants at risk
Included the adverse events occurred from enrollment to randomization where subjects were either under cDBS or temporarily under aDBS during setup and adjustment phase. This group included subjects from both Primary Cohort and Directional stimulation Cohort.
|
Primary Cohort aDBS Single Threshold Mode
n=35 participants at risk
Included the adverse events occurred after Primary Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Single Threshold Mode.
|
Primary Cohort aDBS Dual Threshold Mode
n=40 participants at risk
Included the adverse events occurred after Primary Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Dual Threshold Mode.
|
Directional Stimulation Cohort aDBS Single Threshold Mode
n=13 participants at risk
Included the adverse events occurred after Directional Stimulation Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Single Threshold Mode.
|
Directional Stimulation Cohort aDBS Dual Threshold Mode
n=15 participants at risk
Included the adverse events occurred after Directional Stimulation Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Dual Threshold Mode.
|
|---|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/85 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
2.9%
1/35 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/40 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/15 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Injury, poisoning and procedural complications
Spinal fracture
|
0.00%
0/85 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
2.9%
1/35 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/40 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/15 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
Other adverse events
| Measure |
Enrollment to Randomization
n=85 participants at risk
Included the adverse events occurred from enrollment to randomization where subjects were either under cDBS or temporarily under aDBS during setup and adjustment phase. This group included subjects from both Primary Cohort and Directional stimulation Cohort.
|
Primary Cohort aDBS Single Threshold Mode
n=35 participants at risk
Included the adverse events occurred after Primary Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Single Threshold Mode.
|
Primary Cohort aDBS Dual Threshold Mode
n=40 participants at risk
Included the adverse events occurred after Primary Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Dual Threshold Mode.
|
Directional Stimulation Cohort aDBS Single Threshold Mode
n=13 participants at risk
Included the adverse events occurred after Directional Stimulation Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Single Threshold Mode.
|
Directional Stimulation Cohort aDBS Dual Threshold Mode
n=15 participants at risk
Included the adverse events occurred after Directional Stimulation Cohort subjects entered the aDBS Evaluation Phase. This group combined the subjects from the crossover arm and one mode arm where the adverse events happened during the aDBS Dual Threshold Mode.
|
|---|---|---|---|---|---|
|
General disorders
Gait disturbance
|
0.00%
0/85 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
5.7%
2/35 • Number of events 2 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
5.0%
2/40 • Number of events 2 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
6.7%
1/15 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
General disorders
Propulsive gait
|
0.00%
0/85 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/35 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/40 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
6.7%
1/15 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Nervous system disorders
Dysarthria
|
3.5%
3/85 • Number of events 3 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/35 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/40 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
7.7%
1/13 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/15 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Nervous system disorders
Dyskinesia
|
18.8%
16/85 • Number of events 22 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
8.6%
3/35 • Number of events 4 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
10.0%
4/40 • Number of events 5 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
6.7%
1/15 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Nervous system disorders
Dystonia
|
1.2%
1/85 • Number of events 2 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
2.9%
1/35 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
7.5%
3/40 • Number of events 3 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
6.7%
1/15 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Nervous system disorders
Freezing phenomenon
|
1.2%
1/85 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
2.9%
1/35 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
5.0%
2/40 • Number of events 2 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/13 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
6.7%
1/15 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Nervous system disorders
Parkinson's disease (worsening)
|
15.3%
13/85 • Number of events 14 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
14.3%
5/35 • Number of events 6 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
20.0%
8/40 • Number of events 9 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
15.4%
2/13 • Number of events 2 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
20.0%
3/15 • Number of events 4 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
|
Nervous system disorders
Tremor
|
8.2%
7/85 • Number of events 8 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
8.6%
3/35 • Number of events 3 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
2.5%
1/40 • Number of events 1 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
15.4%
2/13 • Number of events 4 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
0.00%
0/15 • From subject enrollment to subject last visit or subject exit, an average of 15 months.
In order to assess the adverse events by intervention/mode, adverse events that were related to device and/or therapy, i.e., stimulation related adverse events are presented here. The groups are: Enrollment to Randomization, PC aDBS Single Mode, PC aDBS Dual Mode, DS aDBS Single Mode, DS aDBS Dual Mode. Subjects may be in more than one group. Enrollment to Randomization includes cDBS and aDBS setup and adjustment phases. One death was not related to device, procedure, therapy, or stimulation.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place