Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

A study testing Adaptive DBS in people with Parkinson Disease, run by MedtronicNeuro at 10 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Adaptive DBS
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 85 participants
Where: 10 sitesin 4 countries
Study dates: 14 Dec 2020to 2 May 2025
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

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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

Who cannot join

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

Show all 16Show fewer

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

Trial locations and contacts

10 sites in 4 countries.

Country

City, postcode or hospital

10 sites in 4 countries

United States7 sites

Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic
Cleveland, Ohio, 44195
Duke University
Durham, North Carolina, 27710
University of Florida
Gainesville, Florida, 32608
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
University of California San Francisco
San Francisco, California, 94115
Stanford University Medical Center
Stanford, California, 94305

Other trials in United States

Canada1 site

Toronto Western Hospital
Toronto, Ontario, M5T 25B

Other trials in Canada

France1 site

UJF Grenoble
Grenoble

Other trials in France

Netherlands1 site

Amsterdam UMC, location AMC
Amsterdam, 1105 AZ

Other trials in Netherlands

About this study

Official title: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)

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: Parkinson Disease
Being tested: Adaptive DBS
Keywords: Deep Brain Stimulation, Parkinson's Disease
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Adaptive DBSDevice
Also called aDBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS

Study groups in NCT04547712
Study group	Role	What they receive
aDBS Single Threshold	Experimental	Adaptive DBS Single Threshold Mode Receives: Device: Adaptive DBS
aDBS Dual Threshold	Experimental	Adaptive DBS Dual Threshold Mode Receives: Device: Adaptive DBS

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: About one month

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 Dec 20202 May 2025

First posted14 Sep 2020
Study start14 Dec 2020
Primary completion12 Jan 2023
Study completion2 May 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Model description: Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes
Masking: Single blind
Who is masked: Participant
Enrolment: 85 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04547712
Sponsor's protocol ID: MDT19001
Acronym: ADAPT-PD
Status last verified: Jul 2025
First submitted: 20 Aug 2020
Last updated: 8 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
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A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm

All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)
ClinicalTrials.gov ID: NCT04547712
Acronym / sponsor ID: ADAPT-PD / MDT19001
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation, Parkinson's Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 85 participants (actual)
Lead sponsor: MedtronicNeuroIndustry (pharma, biotech, devices)
Study start: 14 Dec 2020 (actual)
Primary completion: 12 Jan 2023 (actual)
Study completion: 2 May 2025 (actual)
First posted: 14 Sep 2020 (actual)
Results: Posted 8 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes

Arm	Type	Receives
aDBS Single Threshold	Experimental	Device: Adaptive DBSAdaptive DBS Single Threshold Mode
aDBS Dual Threshold	Experimental	Device: Adaptive DBSAdaptive DBS Dual Threshold Mode

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (16 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Adaptive DBSAlso: aDBSSubjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS	Device	aDBS Dual Threshold, aDBS Single Threshold

Primary outcome

Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
Time frame: About one month
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.

1 secondary outcome

Stimulation Energy Use
Time frame: About one month

Results and safety

Results posted to the registry on 8 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Primary Cohort, Crossover Sequence 1: aDBS Single Threshold Mode, Then aDBS Dual Threshold Mode	16	16
Primary Cohort, Crossover Sequence 2: aDBS Dual Threshold Mode, Then aDBS Single Threshold Mode	14	14
Primary Cohort, One Mode: aDBS Single Threshold Mode	5	5
Primary Cohort, One Mode: aDBS Dual Threshold Mode	10	10
Directional Stimulation Cohort, Crossover Sequence 1: aDBS Single, Then aDBS Dual Threshold Mode	6	6
Directional Stimulation Cohort, Crossover Sequence 2: aDBS Dual, Then aDBS Single Threshold Mode	7	7
Directional Stimulation Cohort, One Mode: aDBS Dual Threshold Mode	2	2

Primary outcome: Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.

Time frame: About one month. Number (97.5% Confidence Interval). Unit: percentage of participant

Measure	Primary Cohort aDBS Single Threshold n = 35	Primary Cohort aDBS Dual Threshold n = 40
Value	78.9 (59.4 to NA)	91 (75.6 to NA)

Primary Cohort aDBS Single Threshold: Proportion expressed as a percentage: 78.9
Primary Cohort aDBS Dual Threshold: Proportion expressed as a percentage: 91.0

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From subject enrollment to subject last visit or subject exit, an average of 15 months.. Other adverse events reported at 5% frequency or more

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40982287Bronte-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.
Derived from this study: PubMed 35346837Swinnen 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.
Individual participant dataSharing planned: No

Related trials for Parkinson Disease

RecruitingObservational study
Evaluation and Treatment of Neurosurgical Disorders
Neurologic Disorders
Enrolling by invitation
Efficacy of Repetitive Transcranial Magnetic Stimulation for Improving Depressive Symptoms in Patients With Parkinson's Disease
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RecruitingPhase 1/2
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
Carcinoma, Non-Small-Cell Lung
Active, not recruitingPhase 2
A Pilot Study to Investigate the Safety and Clinical Activity of Avelumab (MSB0010718C) in Thymoma and Thymic Carcinoma After Progression on Platinum-Based Chemotherapy
Thymoma, Thymic Carcinoma
Not yet recruitingObservational study
Twenty-five Years of Advanced RadioTherapy at San Raffaele Hospital
Malignant Tumor, Benign Neoplasm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Bronte-Stewart, MD, MSE principal investigator

Stanford University

10 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Adaptive DBS in people with Parkinson Disease, run by MedtronicNeuro at 10 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada, France, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold. (time frame: About one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04547712, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.