Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease (ADAPT-PD)
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ClinicalTrials.gov Identifier: NCT04547712 |
Recruitment Status :
Recruiting
First Posted : September 14, 2020
Last Update Posted : May 10, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Parkinson Disease | Device: Adaptive DBS | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Intervention Model Description: | Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease |
Actual Study Start Date : | December 14, 2020 |
Estimated Primary Completion Date : | February 2023 |
Estimated Study Completion Date : | October 2023 |

Arm | Intervention/treatment |
---|---|
Experimental: aDBS Single Threshold
Adaptive DBS Single Threshold Mode
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Device: Adaptive DBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Other Name: aDBS |
Experimental: aDBS Dual Threshold
Adaptive DBS DualThreshold Mode
|
Device: Adaptive DBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Other Name: aDBS |
- On time without troublesome dyskinesia [ Time Frame: Change from Baseline at 1 and 2 months post-randomization ]Proportion of aDBS subjects with "On" time without troublesome dyskinesia exceeding the threshold (aDBS is no worse than one standard deviation less than cDBS).
- Stimulation energy use [ Time Frame: Change from Baseline at 1 and 2 months post-randomization ]Total electrical energy delivered (TEED) for aDBS as compared with cDBS.
- Safety (Stimulation-related AEs) [ Time Frame: Up to 45 days per mode (average of 30 days) ]To characterize stimulation-related adverse events
- Safety (SAEs, AEs and DDs) [ Time Frame: Through study completion, approximately 1.5 years ]To characterize serious adverse events, adverse events and device deficiencies

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General
- Subject has idiopathic Parkinson's disease
- Subject is implanted with Percept PC (Model B35200) and Medtronic DBS leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), STN or 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)
LFP Screening Inclusion Criteria
1. Subject has required Beta band (8-30 Hz) amplitude 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04547712
Contact: ADAPT-PD Trial Clinical Research Team | 800-328-0810 | rs.adapt-pdtrial@medtronic.com |
United States, California | |
University of California San Francisco | Recruiting |
San Francisco, California, United States, 94115 | |
Stanford University Medical Center | Recruiting |
Stanford, California, United States, 94305 | |
United States, Florida | |
University of Florida | Recruiting |
Gainesville, Florida, United States, 32608 | |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
United States, North Carolina | |
Duke University | Recruiting |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Cleveland Clinic | Recruiting |
Cleveland, Ohio, United States, 44195 | |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Canada, Ontario | |
Toronto Western Hospital | Recruiting |
Toronto, Ontario, Canada, M5T 25B | |
France | |
UJF Grenoble | Recruiting |
Grenoble, France | |
Hôpital Pitie Salpetrière | Recruiting |
Paris, France | |
Netherlands | |
Amsterdam UMC, location AMC | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
United Kingdom | |
Oxford University Hospital | Recruiting |
Oxford, United Kingdom |
Principal Investigator: | Helen Bronte-Stewart, MD, MSE | Stanford University |
Responsible Party: | MedtronicNeuro |
ClinicalTrials.gov Identifier: | NCT04547712 |
Other Study ID Numbers: |
MDT19001 |
First Posted: | September 14, 2020 Key Record Dates |
Last Update Posted: | May 10, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |
Deep Brain Stimulation Parkinson's Disease |
Parkinson Disease Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Movement Disorders Synucleinopathies Neurodegenerative Diseases |