Purpose

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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
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. Subject is configured to monopolar or dual monopolar stimulation using contacts 1 and/or 2 (9 and/or 10) on at least one side. For subjects with the SenSight system, all segments activated per electrode level (ring mode) (Primary Cohort) OR with one or two segments active per level (directional stimulation) on at least one side (Directional Stimulation Cohort) 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Intervention Model Description
Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
MedtronicNeuro

Study Contact

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

Detailed Description

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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.