Parkinson's Disease Clinical Trial
Official title:
DBS-Expert: Automated Deep Brain Stimulation Programming Using Functional Mapping - Phase I
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.
Status | Completed |
Enrollment | 7 |
Est. completion date | August 2014 |
Est. primary completion date | August 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | University of Cincinnati Department of Neurology | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
Great Lakes NeuroTechnologies Inc. | National Institute of Neurological Disorders and Stroke (NINDS), University of Cincinnati |
United States,
Heldman DA, Pulliam CL, Urrea Mendoza E, Gartner M, Giuffrida JP, Montgomery EB Jr, Espay AJ, Revilla FJ. Computer-Guided Deep Brain Stimulation Programming for Parkinson's Disease. Neuromodulation. 2016 Feb;19(2):127-32. doi: 10.1111/ner.12372. Epub 2015 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline in Unified Parkinson's Disease Rating Scale III Score After Guided DBS Programming | Within two days of standard clinical DBS programming session | No | |
Secondary | Change from Baseline in Kinesia HomeView Symptom Ratings After Guided DBS Programming | Within two days of standard clinical DBS programming session | No |
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