CompletedNCT04547712ADAPT-PDUpdated Jul 8, 2025Results posted

Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

An interventional study of Adaptive DBS in Parkinson Disease, sponsored by MedtronicNeuro. Completed at 10 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-08.

Sponsored by MedtronicNeuro · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 85
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.

Read the detailed description

Prospective single-blind, randomized crossover, multi-center study of aDBS in subjects with Parkinson's disease.

Conditions studied

Parkinson Disease

Browse trials for

Parkinson Disease 4,487

Keywords

Deep Brain Stimulation
Parkinson's Disease

In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's enrollment of 85 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

MedtronicNeuro is the lead sponsor of 69 studies on the registry; 2 are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 16 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 85 participants (actual)

Study arms

Experimental
aDBS Single Threshold
Adaptive DBS Single Threshold Mode
Device: Adaptive DBS
Experimental
aDBS Dual Threshold
Adaptive DBS Dual Threshold Mode
Device: Adaptive DBS

Interventions

DeviceAdaptive DBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Also known as: aDBS

What researchers measure

Primary outcomes

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.
Time frame: About one month

Secondary outcomes

Stimulation Energy Use
Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.
Time frame: About one month

Other outcomes

Safety (Stimulation-related AEs)
To characterize stimulation-related adverse events
Time frame: About one month

Results

Posted Jul 8, 2025

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.

cDBS Baseline (~ 30 Days)

Participant flow — cDBS Baseline (~ 30 Days)
Milestone	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
Started	16	14	5	10	6	7	2
Completed	16	14	5	10	6	7	2
Not completed	0	0	0	0	0	0	0

aDBS Setup & Adjustment (up to 65 Days)

Participant flow — aDBS Setup & Adjustment (up to 65 Days)
Milestone	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
Started	16	14	5	10	6	7	2
Completed	16	14	5	10	6	7	2
Not completed	0	0	0	0	0	0	0

Crossover: 1st Intervention (~ 30 Days)

Participant flow — Crossover: 1st Intervention (~ 30 Days)
Milestone	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode
Started	16	14	6	7
Completed	16	14	6	7
Not completed	0	0	0	0

Crossover: 2nd Intervention (~ 30 Days)

Participant flow — Crossover: 2nd Intervention (~ 30 Days)
Milestone	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode
Started	16	14	6	7
Completed	16	14	6	7
Not completed	0	0	0	0

One Mode: Single Threshold (~ 30 Days)

Participant flow — One Mode: Single Threshold (~ 30 Days)
Milestone	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
Started	0	0	5	0	0	0	0
Completed	0	0	5	0	0	0	0
Not completed	0	0	0	0	0	0	0

One Mode: Dual Threshold (~ 30 Days)

Participant flow — One Mode: Dual Threshold (~ 30 Days)
Milestone	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode
Started	10	2
Completed	10	0
Not completed	0	2

Outcome measures

PrimaryProportion 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.

Time frame:: About one month
Reported as:: Number · percentage of participant

Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
percentage of participant	Primary Cohort aDBS Single Threshold	Primary Cohort aDBS Dual Threshold
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.	78.9 (59.4 to NA)	91 (75.6 to NA)

Statistical analysis

Primary Cohort aDBS Single Threshold · Proportion expressed as a percentage: 78.9The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.
Primary Cohort aDBS Dual Threshold · Proportion expressed as a percentage: 91.0The confidence interval lower limit was above the performance goal of 50%, the primary objective was met.

SecondaryStimulation Energy Use

Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.

Time frame:: About one month
Reported as:: Mean · micro Watts

Stimulation Energy Use
micro Watts	aDBS Single Threshold	aDBS Dual Threshold
Stimulation Energy Use	-22.3 (-42.0 to -2.6)	-22.3 (-48 to 3.3)

Statistical analysis

aDBS Single Threshold · t-test, 2 sided · p = 0.0120 (Nominal p-value is provided.)
aDBS Dual Threshold · t-test, 2 sided · p = 0.0491 (Nominal p-value is provided.)

Other pre-specifiedSafety (Stimulation-related AEs)

To characterize stimulation-related adverse events

Time frame:: About one month
Reported as:: Count of participants · Participants

Safety (Stimulation-related AEs)
Participants	Primary Cohort at cDBS Baseline	Primary Cohort: aDBS Single Threshold Mode	Primary Cohort: aDBS Dual Threshold Mode
Safety (Stimulation-related AEs)	3	8	5

Adverse events

Collected over From subject enrollment to subject last visit or subject exit, an average of 15 months.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Enrollment to Randomization	0/85 (0%)	0/85 (0%)	32/85 (37.6%)
Primary Cohort aDBS Single Threshold Mode	1/35 (2.9%)	1/35 (2.9%)	10/35 (28.6%)
Primary Cohort aDBS Dual Threshold Mode	0/40 (0%)	0/40 (0%)	16/40 (40%)
Directional Stimulation Cohort aDBS Single Threshold Mode	0/13 (0%)	0/13 (0%)	4/13 (30.8%)
Directional Stimulation Cohort aDBS Dual Threshold Mode	0/15 (0%)	0/15 (0%)	5/15 (33.3%)

Most frequent serious events

Most frequent serious events
Event	Enrollment to Randomization	Primary Cohort aDBS Single Threshold Mode	Primary Cohort aDBS Dual Threshold Mode	Directional Stimulation Cohort aDBS Single Threshold Mode	Directional Stimulation Cohort aDBS Dual Threshold Mode
FallInjury, poisoning and procedural complications	0/85	1/35	0/40	0/13	0/15
Spinal fractureInjury, poisoning and procedural complications	0/85	1/35	0/40	0/13	0/15

Most frequent other events

Most frequent other events
Event	Enrollment to Randomization	Primary Cohort aDBS Single Threshold Mode	Primary Cohort aDBS Dual Threshold Mode	Directional Stimulation Cohort aDBS Single Threshold Mode	Directional Stimulation Cohort aDBS Dual Threshold Mode
Parkinson's disease (worsening)Nervous system disorders	13/85	5/35	8/40	2/13	3/15
DyskinesiaNervous system disorders	16/85	3/35	4/40	0/13	1/15
TremorNervous system disorders	7/85	3/35	1/40	2/13	0/15
DysarthriaNervous system disorders	3/85	0/35	0/40	1/13	0/15
DystoniaNervous system disorders	1/85	1/35	3/40	0/13	1/15
Gait disturbanceGeneral disorders	0/85	2/35	2/40	0/13	1/15
Propulsive gaitGeneral disorders	0/85	0/35	0/40	0/13	1/15
Freezing phenomenonNervous system disorders	1/85	1/35	2/40	0/13	1/15

Baseline characteristics

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.

Age, Continuous
Age, Continuous(years)	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode	Total
Mean	60.6 ± 9.49	64.2 ± 7.62	59.6 ± 7.16	59.6 ± 10.08	59.7 ± 4.18	61.0 ± 8.08	58.0 ± 2.83	61.1 ± 8.15

Sex: Female, Male
Sex: Female, Male(Participants)	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode	Total
Female	4	5	4	2	1	2	1	19
Male	12	9	1	8	5	5	1	41

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode	Total
Hispanic or Latino	0	1	0	0	1	1	0	3
Not Hispanic or Latino	13	10	2	7	5	6	2	45
Unknown or Not Reported	3	3	3	3	0	0	0	12

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode	Total
American Indian or Alaska Native	0	0	0	0	0	0	0	0
Asian	0	0	0	1	1	0	0	2
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0
Black or African American	0	0	0	1	0	0	0	1
White	13	11	2	5	4	6	2	43
More than one race	0	0	0	0	0	0	0	0
Unknown or Not Reported	3	3	3	3	1	1	0	14

Region of Enrollment
Region of Enrollment(participants)	Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Single Threshold Mode	Primary Cohort, One Mode: aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode	Total
Canada	0	2	0	2	0	0	0	4
Netherlands	2	1	2	1	0	0	0	6
United States	13	11	2	7	6	7	2	48
France	1	0	1	0	0	0	0	2

Study locations

10 sites

University of California San Francisco
San Francisco, California 94115, United States
Stanford University Medical Center
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

References and documents

Publications

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. PubMed 40982287 ↗
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. PubMed 35346837 ↗

Study documents

Study protocol · Sep 11, 2023
Statistical analysis plan · Oct 19, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04547712
Lead sponsor: MedtronicNeuro
Responsible party: Sponsor
First posted: Sep 14, 2020
Start date: Dec 14, 2020
Primary completion: Jan 12, 2023
Completion: May 2, 2025
Results posted: Jul 8, 2025
Last update: Jul 8, 2025

Study contacts

Helen Bronte-Stewart, MD, MSE

principal investigator · Stanford University

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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