Adaptive DBS Algorithm for Personalized Therapy in Parkinson's Disease

Not Applicable

Completed

Conditions: Parkinson Disease

Registration Number: NCT04547712

Lead Sponsor: MedtronicNeuro

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 85

Inclusion Criteria

General

Subject has idiopathic Parkinson's disease
Subject is implanted with Percept PC (Model B35200) and Medtronic Deep Brain Stimulation (DBS) leads (Model 3387, 3389, B33005 or B33015) and extensions (Model 37085, 37086, or B34000) bilaterally in the same target (physician confirmed), subthalamic nucleus (STN) or Globus Pallidus (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.
(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)

Local Field Potential (LFP) Screening Inclusion Criteria

Subject has required Alpha-Beta band (8-30 Hz) amplitude ≥ 1.2 µVp 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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.	About one month	In the PD Home Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The PD Home Diary was collected at both the cDBS Baseline and aDBS Evaluation Phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.

Secondary Outcome Measures

Name	Time	Method
Stimulation Energy Use	About one month	Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.

Trial Locations

Locations (10): University of California San Francisco
🇺🇸
San Francisco, California, United States
Stanford University Medical Center
🇺🇸
Stanford, California, United States
University of Florida
🇺🇸
Gainesville, Florida, United States
Massachusetts General Hospital
🇺🇸
Boston, Massachusetts, United States
Duke University
🇺🇸
Durham, North Carolina, United States
Cleveland Clinic
🇺🇸
Cleveland, Ohio, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States
Toronto Western Hospital
🇨🇦
Toronto, Ontario, Canada
UJF Grenoble
🇫🇷
Grenoble, France
Amsterdam UMC, location AMC
🇳🇱
Amsterdam, Netherlands
University of California San Francisco
🇺🇸San Francisco, California, United States