DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming
Study Overview
Brief Summary
The clinical utility of deep brain stimulation (DBS) for the treatment of movement disorders such as Parkinson's disease has been well established; however, there is a great disparity in outcomes among DBS recipients due to varied postoperative management, particularly concerning the choosing of an optimal set of programming parameters from the thousands of possible combinations. This study will evaluate the use of motion sensor based assessments to develop a functional map and algorithms to automatically determine a set of programming parameters that maximize symptomatic benefits while minimizing side effects and battery consumption.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Clinical diagnosis of idiopathic Parkinson's disease
- •Implanted deep brain stimulation system awaiting initial programming session
Exclusion Criteria
- •Subjects with significant psychiatric illness or dementia
- •Significant cognitive impairment
Outcomes
Primary Outcomes
Percent Change From Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming
Time Frame: Within two days of standard clinical DBS programming session
Symptoms were first assessed with the implanted pulse generator (IPG) turned off for at least 30 minutes to allow the after-effects of stimulation to wear off (baseline). Symptoms were measured again with the IPG turned on at a setting that both minimized the average severity of tremor and bradykinesia and minimized side effects. The Kinesia score rated symptom severity (0, normal; 4, most severe) in four categories: tremor, finger tapping speed, finger tapping amplitude, and finger tapping rhythm. Scores for the four motor symptoms were averaged and converted to percent change from baseline.
Secondary Outcomes
No secondary outcomes reported