The purpose of the study is to demonstrate the safety and effectiveness of adaptive DBS (aDBS) for Parkinson's disease.
Prospective single-blind, randomized crossover, multi-center study of aDBS in subjects with Parkinson's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
85
Subjects for whom both aDBS modes are acceptable will receive Dual and Single Threshold aDBS
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
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold.
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.
Time frame: About one month
Stimulation Energy Use
Total electrical energy delivered (TEED) for aDBS as compared with cDBS, calculated as TEED at aDBS - TEED at cDBS.
Time frame: About one month
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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