Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

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

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

Official Title
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Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Adaptive DBS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: General Subject has idiopathic Parkinson's disease 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 In the opinion of the investigator, the subject responds to DBS Therapy. 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 (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: Subject and/or caregiver is unable to utilize the patient programmer Subject has more than one lead in each hemisphere of the brain Subject has cortical leads or additional unapproved hardware implanted in the brain Subject has more than one INS At enrollment, the subject's INS has a predicted battery life of <1 year Subject has Beck Depression Inventory II (BDI-II) > 25 Subject requires diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) Subject has a metallic implant in the head, (eg, aneurysm clip, cochlear implant) Subject has, or plans to obtain, an implanted electrical stimulation medical device anywhere in the body (eg, cardiac pacemaker, defibrillator, spinal cord stimulator) 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 Based on the opinion of the investigator, the subject has an abnormal neurological examination that would preclude them from study participation Subject is breast feeding Subject is under the age of 18 years 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 Subject is unable to use or tolerate wearable Subjects with signal artifact on all 6 aDBS sense pathways (3 each on both DBS leads) which preclude the clinician from setting thresholds

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomization to a crossover sequence of aDBS single threshold and aDBS dual threshold modes
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: aDBS Single Threshold<br>Adaptive DBS Single Threshold Mode | Device: Adaptive DBS<br>* Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS<br>* Other names: aDBS;|
| Experimental: aDBS Dual Threshold<br>Adaptive DBS DualThreshold Mode | Device: Adaptive DBS<br>* Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS<br>* Other names: aDBS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On time without troublesome dyskinesia | Proportion of aDBS subjects with On time without troublesome dyskinesia exceeding the threshold (aDBS is no worse than one standard deviation less than cDBS). | Change from Baseline at 1 and 2 months post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stimulation energy use | Total electrical energy delivered (TEED) for aDBS as compared with cDBS. | Change from Baseline at 1 and 2 months post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Deep Brain Stimulation, Parkinson's Disease