Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Stanford University
- Enrollment
- 34
- Locations
- 1
- Primary Endpoint
- Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief Summary
The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. vCR will be administered with a device called the Stanford Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as Levodopa and/or deep brain stimulation. Patients will be followed for 14 months.
Detailed Description
The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.
Investigators
Vivek P. Buch
Assistant Professor of Neurosurgery
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Ages 18 or older
- •Diagnosed with idiopathic Parkinson's Disease
- •Fluent in English
- •Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.
- •Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.
Exclusion Criteria
- •Participation in another drug, device, or biologics trial concurrently or within the preceding 30 days. Any other trial participation should be approved by the Principal Investigators.
- •Pregnancy, breast-feeding or wanting to become pregnant
- •Physical limitations unrelated to PD that would affect motor ratings
- •Has implantation of a medical device
- •Sensory abnormalities of the fingertips
Outcomes
Primary Outcomes
Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score
Time Frame: Baseline and month 6
Mean change in the MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score. Minimum score - 0 indicates normal functioning Maximum score - 132 indicated severe impairment Lower scores indicate greater functionality and higher scores indicate severe impairment in functionality.