Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

Description

Summary

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

Details

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

Keywords

Parkinson Disease Deep Brain Stimulation Parkinson's Disease Adaptive DBS aDBS Single Threshold aDBS Dual Threshold

Eligibility

You can join if…

Open to people ages 18 years and up

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

You CAN'T join if...

  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)

Locations

  • University of California San Francisco accepting new patients
    San Francisco California 94115 United States
  • Stanford University Medical Center accepting new patients
    Stanford California 94305 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
MedtronicNeuro
ID
NCT04547712
Study Type
Interventional
Last Updated