Adaptive DBS Algorithm for Personalized Therapy in Parkin... | NCT04547712 | Trialant
NCT04547712
Sponsor
MedtronicNeuro
Status
Completed
Last Update Posted
Jul 8, 2025Actual
Enrollment
85Actual
Phase
Not Applicable
Conditions
Parkinson Disease
Interventions
Adaptive DBS
Countries
United States
Canada
France
Netherlands
Protocol Section
Identification Module
NCT ID
Results Section
Participant Flow Module
Pre-assignment Details
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Derived Section
Miscellaneous Info Module
Version Holder
NCT04547712
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
MDT19001
Secondary IDs
Not provided
Brief Title
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Official Title
Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)
Acronym
ADAPT-PD
Organization
MedtronicNeuroINDUSTRY
Status Module
Record Verification Date
Jul 2025
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Dec 14, 2020Actual
Primary Completion Date
Jan 12, 2023Actual
Completion Date
May 2, 2025Actual
First Submitted Date
Aug 20, 2020
First Submission Date that Met QC Criteria
Sep 10, 2020
First Posted Date
Sep 14, 2020Actual
Results Waived
Not provided
Results First Submitted Date
Mar 19, 2025
Results First Submitted that Met QC Criteria
Jul 2, 2025
Results First Posted Date
Jul 8, 2025Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jan 4, 2024
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Jul 8, 2025Actual
Last Update Submitted Date
Jul 2, 2025
Last Update Posted Date
Jul 8, 2025Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
MedtronicNeuroINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
No
Is FDA Regulated Device
Yes
Is Unapproved Device
Yes
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.
Detailed Description
Prospective single-blind, randomized crossover, multi-center study of aDBS in subjects with Parkinson's disease.
Conditions Module
Conditions
Parkinson Disease
Keywords
Deep Brain Stimulation
Parkinson's Disease
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Not Applicable
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
85Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
aDBS Single Threshold
Experimental
Adaptive DBS Single Threshold Mode
Device: Adaptive DBS
aDBS Dual Threshold
Experimental
Adaptive DBS Dual Threshold Mode
Device: Adaptive DBS
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Adaptive DBS
Device
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
aDBS Dual Threshold
aDBS Single Threshold
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
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.
About one month
Secondary Outcomes
Measure
Description
Time Frame
Stimulation Energy Use
Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.
About one month
Other Outcomes
Measure
Description
Time Frame
Safety (Stimulation-related AEs)
To characterize stimulation-related adverse events
About one month
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
General
Subject has idiopathic Parkinson's disease
Subject is implanted with Percept PC (Model B35200) and Medtronic Deep Brain Stimulation (DBS) leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), subthalamic nucleus (STN) or Globus Pallidus (GPi)
In the opinion of the investigator, the subject responds to DBS Therapy.
Based on the opinion of the investigator, the subject's cDBS parameters and PD medications are stable and expected to remain stable from enrollment through the end of the aDBS Evaluation phase
(Primary Cohort) Subject is configured to ring mode monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side.
5. (Directional Stimulation Cohort) Subject is configured to directional monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) 6. Subject is willing and able to attend all study-required visits and complete the study procedures (e.g. 1-month recall questionnaires, MDS-UPDRS III) 7. Subject has the ability to understand and provide written informed consent for participation in the study prior to the study-related procedures being conducted 8. Subject is a male or non-pregnant female. If female of child-bearing potential, and if sexually active, must be using, or agree to use, a medically-acceptable method of birth control as confirmed by the investigator 9. For subjects with the SenSight system: Subject is configured to the following stimulation rates: 55, 85, 110, 125, 145, 164 or 180 Hz (as required for sensing/aDBS)
Local Field Potential (LFP) Screening Inclusion Criteria
1. Subject has required Alpha-Beta band (8-30 Hz) amplitude ≥ 1.2 µVp detected on either left and/or right DBS leads
Exclusion Criteria:
Subject and/or caregiver is unable to utilize the patient programmer
Subject has more than one lead in each hemisphere of the brain
Subject has cortical leads or additional unapproved hardware implanted in the brain
Subject has more than one INS
At enrollment, the subject's INS has a predicted battery life of <1 year
Subject has Beck Depression Inventory II (BDI-II) > 25
Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)
Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)
Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)
Subject has, or plans to obtain, an implanted medication pump for the treatment of Parkinson's disease (eg, DUOPATM infusion pump) and/or portable infusion pump
Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation
Subject is breast feeding
Subject is under the age of 18 years
Subject is currently enrolled in or plans to enroll in any concurrent drug and/or device study that may confound the results of this study as determined by the Medtronic study team
Subject is unable to use or tolerate wearable
Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds
Bronte-Stewart HM, Beudel M, Ostrem JL, Little S, Almeida L, Ramirez-Zamora A, Fasano A, Hassell T, Mitchell KT, Moro E, Gostkowski M, Chattree G, de Bie RMA, de Neeling M, Pina-Fuentes D, Swinnen B, Starr PA, Hammer LH, Foote KD, Richardson RM, Flaherty A, Boogers A, Sa'di Q, Meoni S, Castrioto A, Stanslaski S, Summers RLS, Tonder L, Tan Y, Berrier H, Goble TJ, Raike RS, Herrington TM; ADAPT-PD Investigators. Long-Term Personalized Adaptive Deep Brain Stimulation in Parkinson Disease: A Nonrandomized Clinical Trial. JAMA Neurol. 2025 Nov 1;82(11):1171-1180. doi: 10.1001/jamaneurol.2025.2781.
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.
Recruitment Details
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.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
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 SenSightâ„¢ 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.
FG001
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 SenSightâ„¢ 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.
FG002
Primary Cohort, One Mode: aDBS Single Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSightâ„¢ lead model B33005 or B33015 programmed to ring mode stimulation, received only Single Threshold evaluation for about one month.
FG003
Primary Cohort, One Mode: aDBS Dual Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSightâ„¢ lead model B33005 or B33015 programmed to ring mode stimulation, received only Dual Threshold evaluation for about one month.
FG004
Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode
This cohort comprised of study subjects with SenSightâ„¢ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
FG005
Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode
This cohort comprised of study subjects with SenSightâ„¢ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
FG006
Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
This cohort comprised of study subjects with SenSightâ„¢ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
Periods
Title
Milestones
Reasons Not Completed
cDBS Baseline (~ 30 Days)
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00114 subjects
FG0025 subjects
FG00310 subjects
FG004
COMPLETED
FG00016 subjects
FG00114 subjects
FG0025 subjects
FG00310 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
aDBS Setup & Adjustment (up to 65 Days)
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00114 subjects
FG0025 subjects
FG003
Crossover: 1st Intervention (~ 30 Days)
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00114 subjects
FG0020 subjectsThe flow of the participants from One Mode is addressed in the periods for One Mode.
FG003
Crossover: 2nd Intervention (~ 30 Days)
Type
Comment
Milestone Data
STARTED
FG00016 subjects
FG00114 subjects
FG0020 subjects
FG003
One Mode: Single Threshold (~ 30 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsThe flow of the participants from the Crossover arm is addressed in the periods for Crossover Sequences.
FG0010 subjectsThe flow of the participants from the Crossover arm is addressed in the periods for Crossover Sequences.
FG0025 subjectsThe flow of the participants from Single Threshold Mode is addressed in the period for One Mode - Single Threshold.
One Mode: Dual Threshold (~ 30 Days)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjectsThe flow of the participants from Single Threshold Mode is addressed in the period for One Mode - Single Threshold.
FG003
Baseline Characteristics Module
Baseline Analysis Population Description
The 60 subjects who entered into the aDBS Evaluation Phase of the study are summarized for baseline characteristics so that arms/groups can be assigned based on the flowchart.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
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 SenSightâ„¢ 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.
Denominators
Units
Counts
Participants
BG000
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Outcome Measures Module
Outcome Measures
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
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.
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.
Posted
Number
97.5% Confidence Interval
percentage of participant
About one month
Adverse Events Module
Frequency Threshold
5
Time Frame
From subject enrollment to subject last visit or subject exit, an average of 15 months.
Description
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.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Enrollment to Randomization
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.
Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Single
Masking Description
Not provided
Who Masked
Participant
aDBS
Stanford
California
94305
United States
University of Florida
Gainesville
Florida
32608
United States
Massachusetts General Hospital
Boston
Massachusetts
02114
United States
Duke University
Durham
North Carolina
27710
United States
Cleveland Clinic
Cleveland
Ohio
44195
United States
Vanderbilt University Medical Center
Nashville
Tennessee
37232
United States
Toronto Western Hospital
Toronto
Ontario
M5T 25B
Canada
UJF Grenoble
Grenoble
France
Amsterdam UMC, location AMC
Amsterdam
1105 AZ
Netherlands
Derived
Swinnen BEKS, Buijink AW, Pina-Fuentes D, de Bie RMA, Beudel M. Diving into the subcortex: The potential of chronic subcortical sensing for unravelling basal ganglia function and optimization of deep brain stimulation. Neuroimage. 2022 Jul 1;254:119147. doi: 10.1016/j.neuroimage.2022.119147. Epub 2022 Mar 27.
6 subjects
FG0057 subjects
FG0062 subjects
6 subjects
FG0057 subjects
FG0062 subjects
0 subjects
FG0050 subjects
FG0060 subjects
10 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
COMPLETED
FG00016 subjects
FG00114 subjects
FG0025 subjects
FG00310 subjects
FG0046 subjects
FG0057 subjects
FG0062 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
0 subjects
The flow of the participants from One Mode is addressed in the periods for One Mode.
FG0046 subjects
FG0057 subjects
FG0060 subjectsThe flow of the participants from One Mode is addressed in the periods for One Mode.
COMPLETED
FG00016 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0046 subjects
FG0057 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
0 subjects
FG0046 subjects
FG0057 subjects
FG0060 subjects
COMPLETED
FG00016 subjects
FG00114 subjects
FG0020 subjects
FG0030 subjects
FG0046 subjects
FG0057 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0030 subjects
FG0040 subjectsThe flow of the participants from the Crossover arm is addressed in the periods for Crossover Sequences.
FG0050 subjectsThe flow of the participants from the Crossover arm is addressed in the periods for Crossover Sequences.
FG0060 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
10 subjects
The flow of the participants from Dual Threshold Mode is addressed in the period for One Mode - Dual Threshold.
FG0040 subjects
FG0050 subjects
FG0062 subjectsThe flow of the participants from Dual Threshold Mode is addressed in the period for One Mode - Dual Threshold.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00310 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0062 subjects
BG001
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 SenSightâ„¢ 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.
BG002
Primary Cohort, One Mode: aDBS Single Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSightâ„¢ lead model B33005 or B33015 programmed to ring mode stimulation, received only Single Threshold evaluation for about one month.
BG003
Primary Cohort, One Mode: aDBS Dual Threshold Mode
This cohort comprised of study subjects implanted with legacy lead model 3387 or 3389, or with SenSightâ„¢ lead model B33005 or B33015 programmed to ring mode stimulation, received only Dual Threshold evaluation for about one month.
BG004
Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode
This cohort comprised of study subjects with SenSightâ„¢ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
BG005
Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode
This cohort comprised of study subjects with SenSightâ„¢ lead model B33005 or B33015 programmed to directional stimulation, with Single and/or Dual Threshold evaluation for about one month.
BG006
Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
This cohort comprised of study subjects with SenSightâ„¢ lead model B33005 or B33015 programmed to directional stimulation, with Dual Threshold evaluation for about one month.
BG007
Total
Total of all reporting groups
16
BG00114
BG0025
BG00310
BG0046
BG0057
BG0062
BG00760
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00060.6± 9.49
BG00164.2± 7.62
BG00259.6± 7.16
BG00359.6± 10.08
BG00459.7± 4.18
BG00561.0± 8.08
BG00658.0± 2.83
BG00761.1± 8.15
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0004
BG0015
BG0024
BG0032
BG0041
BG0052
BG0061
BG00719
Male
BG00012
BG0019
BG0021
BG0038
BG004
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG0000
BG0011
BG0020
BG0030
BG0041
BG0051
BG0060
BG0073
Not Hispanic or Latino
BG00013
BG00110
BG0022
BG0037
BG004
Unknown or Not Reported
BG0003
BG0013
BG0023
BG0033
BG004
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG0020
BG0030
BG0040
BG0050
BG0060
BG0070
Asian
BG0000
BG0010
BG0020
BG0031
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0020
BG0030
BG004
Black or African American
BG0000
BG0010
BG0020
BG0031
BG004
White
BG00013
BG00111
BG0022
BG0035
BG004
More than one race
BG0000
BG0010
BG0020
BG0030
BG004
Unknown or Not Reported
BG0003
BG0013
BG0023
BG0033
BG004
Region of Enrollment
Number
participants
Title
Denominators
Categories
Canada
Title
Measurements
BG0000
BG0012
BG0020
BG0032
BG0040
BG0050
BG0060
BG0074
Netherlands
Title
Measurements
BG0002
BG0011
BG0022
BG003
United States
Title
Measurements
BG00013
BG00111
BG0022
BG003
France
Title
Measurements
BG0001
BG0010
BG0021
BG003
ID
Title
Description
OG000
Primary Cohort aDBS Single Threshold
Adaptive DBS Single Threshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
OG001
Primary Cohort aDBS Dual Threshold
Adaptive DBS DualThreshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Units
Counts
Participants
OG00035
OG00140
Title
Denominators
Categories
Title
Measurements
OG00078.9(59.4 to NA)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.
OG00191(75.6 to NA)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.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null Hypothesis: The proportion of subjects with "On" time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold <= 50%; Alternative Hypothesis: The proportion of subjects with "On" time without troublesome dyskinesia during aDBS single threshold mode Evaluation Period exceeding threshold > 50%
Proportion expressed as a percentage
78.9
1-Sided
97.5
59.4
The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.
Superiority
OG001
Null Hypothesis: The proportion of subjects with "On" time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold <= 50%; Alternative Hypothesis: The proportion of subjects with "On" time without troublesome dyskinesia during aDBS dual threshold mode Evaluation Period exceeding threshold > 50%
Proportion expressed as a percentage
91.0
1-Sided
97.5
75.6
The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.
Superiority
Secondary
Stimulation Energy Use
Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.
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.
Posted
Mean
97.5% Confidence Interval
micro Watts
About one month
ID
Title
Description
OG000
aDBS Single Threshold
Adaptive DBS Single Threshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
OG001
aDBS Dual Threshold
Adaptive DBS DualThreshold Mode
Adaptive DBS: Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Units
Counts
Participants
OG00035
OG00140
Title
Denominators
Categories
Title
Measurements
OG000-22.3(-42.0 to -2.6)
OG001-22.3(-48 to 3.3)
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
Null Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED >= 0; Alternative Hypothesis: Mean Difference between aDBS single threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED < 0
t-test, 2 sided
0.0120
Nominal p-value is provided.
Superiority
OG001
Other Pre-specified
Safety (Stimulation-related AEs)
To characterize stimulation-related adverse events
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.
Posted
Count of Participants
Participants
No
About one month
ID
Title
Description
OG000
Primary Cohort at cDBS Baseline
Subjects who were included in the Full Analysis Set during cDBS Baseline
OG001
Primary Cohort: aDBS Single Threshold Mode
Adaptive DBS Single Threshold Mode, including subjects in Full Analysis Set who were either randomized to crossover periods or received one mode
OG002
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
Units
Counts
Participants
OG00045
OG00135
OG00240
Title
Denominators
Categories
Title
Measurements
OG0003
OG0018
OG0025
0
85
0
85
32
85
EG001
Primary Cohort aDBS Single Threshold Mode
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.
1
35
1
35
10
35
EG002
Primary Cohort aDBS Dual Threshold Mode
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.
0
40
0
40
16
40
EG003
Directional Stimulation Cohort aDBS Single Threshold Mode
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.
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.
0
15
0
15
5
15
EG0000 events0 affected85 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected15 at risk
Spinal fracture
Injury, poisoning and procedural complications
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0011 events1 affected35 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected13 at risk
EG0040 events0 affected15 at risk
EG0000 events0 affected85 at risk
EG0012 events2 affected35 at risk
EG0022 events2 affected40 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected15 at risk
Propulsive gait
General disorders
MedDRA 26.0
Systematic Assessment
EG0000 events0 affected85 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected40 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected15 at risk
Dysarthria
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0003 events3 affected85 at risk
EG0010 events0 affected35 at risk
EG0020 events0 affected40 at risk
EG0031 events1 affected13 at risk
EG0040 events0 affected15 at risk
Dyskinesia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00022 events16 affected85 at risk
EG0014 events3 affected35 at risk
EG0025 events4 affected40 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected15 at risk
Dystonia
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0002 events1 affected85 at risk
EG0011 events1 affected35 at risk
EG0023 events3 affected40 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected15 at risk
Freezing phenomenon
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0001 events1 affected85 at risk
EG0011 events1 affected35 at risk
EG0022 events2 affected40 at risk
EG0030 events0 affected13 at risk
EG0041 events1 affected15 at risk
Parkinson's disease (worsening)
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG00014 events13 affected85 at risk
EG0016 events5 affected35 at risk
EG0029 events8 affected40 at risk
EG0032 events2 affected13 at risk
EG0044 events3 affected15 at risk
Tremor
Nervous system disorders
MedDRA 26.0
Systematic Assessment
EG0008 events7 affected85 at risk
EG0013 events3 affected35 at risk
EG0021 events1 affected40 at risk
EG0034 events2 affected13 at risk
EG0040 events0 affected15 at risk
Not provided
Results Disclosure Restriction on PI(s)?
No
Other Details
Not provided
D009422
Nervous System Diseases
D009069
Movement Disorders
D000080874
Synucleinopathies
D019636
Neurodegenerative Diseases
5
BG0055
BG0061
BG00741
5
BG0056
BG0062
BG00745
0
BG0050
BG0060
BG00712
1
BG0050
BG0060
BG0072
0
BG0050
BG0060
BG0070
0
BG0050
BG0060
BG0071
4
BG0056
BG0062
BG00743
0
BG0050
BG0060
BG0070
1
BG0051
BG0060
BG00714
1
BG0040
BG0050
BG0060
BG0076
7
BG0046
BG0057
BG0062
BG00748
0
BG0040
BG0050
BG0060
BG0072
Null Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED >= 0; Alternative Hypothesis: Mean Difference between aDBS dual threshold (Evaluation Phase) minus cDBS (Baseline Phase) for TEED < 0