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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 : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
MedtronicNeuro

Tracking Information
First Submitted Date  ICMJE August 20, 2020
First Posted Date  ICMJE September 14, 2020
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE December 14, 2020
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
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).
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2020)
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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: December 10, 2020)
  • 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
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Official Title  ICMJE Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease
Brief Summary 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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Device: Adaptive DBS
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
Other Name: aDBS
Study Arms  ICMJE
  • Experimental: aDBS Single Threshold
    Adaptive DBS Single Threshold Mode
    Intervention: Device: Adaptive DBS
  • Experimental: aDBS Dual Threshold
    Adaptive DBS DualThreshold Mode
    Intervention: Device: Adaptive DBS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 10, 2020)
100
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE July 2023
Estimated Primary Completion Date October 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or 3389) and extensions (Model 37085 and 37086) 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. Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side
  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

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ADAPT-PD Trial Clinical Research Team 800-328-0810 rs.adapt-pdtrial@medtronic.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04547712
Other Study ID Numbers  ICMJE MDT19001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party MedtronicNeuro
Study Sponsor  ICMJE MedtronicNeuro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Helen Bronte-Stewart, MD, MSE Stanford University
PRS Account MedtronicNeuro
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP