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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04547712
Recruitment Status : Recruiting
First Posted : September 14, 2020
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Study Description
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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
Parkinson Disease Device: Adaptive DBS Not Applicable

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

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Safety (Stimulation-related AEs) [ Time Frame: Up to 45 days per mode (average of 30 days) ]
    To characterize stimulation-related adverse events

  2. Safety (SAEs, AEs and DDs) [ Time Frame: Through study completion, approximately 1.5 years ]
    To characterize serious adverse events, adverse events and device deficiencies


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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:

  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
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Information from the National Library of Medicine

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


Contacts
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Contact: ADAPT-PD Trial Clinical Research Team 800-328-0810 rs.adapt-pdtrial@medtronic.com

Locations
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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
Sponsors and Collaborators
MedtronicNeuro
Investigators
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Principal Investigator: Helen Bronte-Stewart, MD, MSE Stanford University
More Information
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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

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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
Keywords provided by MedtronicNeuro:
Deep Brain Stimulation
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases