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ADAPT-PD: Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Sponsor
MedtronicNeuro (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT04547712
Collaborator
(none)
100
Enrollment
12
Locations
2
Arms
40.5
Anticipated Duration (Months)
8.3
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Adaptive DBS
 N/A

Detailed Description

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

Study Design

Study Type:
Interventional
Anticipated 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 modesRandomization 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 :
Dec 14, 2020
Anticipated Primary Completion Date :
Feb 1, 2023
Anticipated Study Completion Date :
May 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: aDBS Single Threshold

Adaptive DBS Single Threshold Mode

Device: Adaptive DBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Other Names:
  • 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 Names:
  • aDBS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. On time without troublesome dyskinesia [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).

    Secondary Outcome Measures

    1. Stimulation energy use [Change from Baseline at 1 and 2 months post-randomization]

      Total electrical energy delivered (TEED) for aDBS as compared with cDBS.

    Other Outcome Measures

    1. Safety (Stimulation-related AEs) [Up to 45 days per mode (average of 30 days)]

      To characterize stimulation-related adverse events

    2. Safety (SAEs, AEs and DDs) [Through study completion, approximately 1.5 years]

      To characterize serious adverse events, adverse events and device deficiencies

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    General

    1. Subject has idiopathic Parkinson's disease

    2. 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

    3. In the opinion of the investigator, the subject responds to DBS Therapy.

    4. 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

    5. (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.

    6. (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:

    1. Subject and/or caregiver is unable to utilize the patient programmer

    2. Subject has more than one lead in each hemisphere of the brain

    3. Subject has cortical leads or additional unapproved hardware implanted in the brain

    4. Subject has more than one INS

    5. At enrollment, the subject's INS has a predicted battery life of <1 year

    6. Subject has Beck Depression Inventory II (BDI-II) > 25

    7. Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT)

    8. Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant)

    9. Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator)

    10. 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

    11. Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation

    12. Subject is breast feeding

    13. Subject is under the age of 18 years

    14. 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

    15. Subject is unable to use or tolerate wearable

    16. Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of California San Francisco San Francisco California United States 94115
    2 Stanford University Medical Center Stanford California United States 94305
    3 University of Florida Gainesville Florida United States 32608
    4 Massachusetts General Hospital Boston Massachusetts United States 02114
    5 Duke University Durham North Carolina United States 27710
    6 Cleveland Clinic Cleveland Ohio United States 44195
    7 Vanderbilt University Medical Center Nashville Tennessee United States 37232
    8 Toronto Western Hospital Toronto Ontario Canada M5T 25B
    9 UJF Grenoble Grenoble France
    10 Hôpital Pitie Salpetrière Paris France
    11 Amsterdam UMC, location AMC Amsterdam Netherlands 1105 AZ
    12 Oxford University Hospital Oxford United Kingdom

    Sponsors and Collaborators

    • MedtronicNeuro

    Investigators

    • Principal Investigator: Helen Bronte-Stewart, MD, MSE, Stanford University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    MedtronicNeuro
    ClinicalTrials.gov Identifier:
    NCT04547712
    Other Study ID Numbers:
    • MDT19001
    First Posted:
    Sep 14, 2020
    Last Update Posted:
    Aug 2, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Keywords provided by MedtronicNeuro
    Deep Brain Stimulation
    Parkinson's Disease
    Additional relevant MeSH terms:
    Parkinson Disease

    Study Results

    No Results Posted as of Aug 2, 2022