NCT04547712

Brief Summary

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for not_applicable parkinson-disease

Timeline
Completed

Started Dec 2020

Longer than P75 for not_applicable parkinson-disease

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 20, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 14, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 12, 2023

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 2, 2025

Completed
2 months until next milestone

Results Posted

Study results publicly available

July 8, 2025

Completed
Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

2.1 years

First QC Date

August 20, 2020

Results QC Date

March 19, 2025

Last Update Submit

July 2, 2025

Conditions

Parkinson Disease

Keywords

Deep Brain StimulationParkinson's Disease

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Stimulation Energy Use

    About one month

Other Outcomes (1)

  • Safety (Stimulation-related AEs)

    About one month

Study Arms (2)

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

Adaptive DBSDEVICE

Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS

Also known as: aDBS
aDBS Dual ThresholdaDBS Single Threshold

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • \. (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)
  • \. Subject has required Alpha-Beta band (8-30 Hz) amplitude ≥ 1.2 µVp detected on either left and/or right DBS leads

You may not qualify if:

  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

University of California San Francisco

San Francisco, California, 94115, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

University of Florida

Gainesville, Florida, 32608, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Toronto Western Hospital

Toronto, Ontario, M5T 25B, Canada

Location

UJF Grenoble

Grenoble, France

Location

Amsterdam UMC, location AMC

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (2)

  • 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.

    PMID: 40982287DERIVED

  • 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.

    PMID: 35346837DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Helen Berrier
Organization
Medtronic Neuromodulation
helen.berrier@medtronic.com
763-526-8178

Study Officials

  • Helen Bronte-Stewart, MD, MSE

    Stanford University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2020

First Posted

September 14, 2020

Study Start

December 14, 2020

Primary Completion

January 12, 2023

Study Completion

May 2, 2025

Last Updated

July 8, 2025

Results First Posted

July 8, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)CA(1)US(7)NL(1)