A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Peter Tass, MD, PhD
- Enrollment
- 7
- Locations
- 1
- Primary Endpoint
- Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.
Detailed Description
This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients. Vibrotactile coordinated reset (vCR) will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants will receive vCR for a minimum of 3 months and a maximum of 13 and motor ability will be recorded. If the results of this study suggest that vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease, this non-invasive treatment approach would have a substantial impact on Parkinson's disease.
Investigators
Peter Tass, MD, PhD
Professor of Neurosurgery
Stanford University
Eligibility Criteria
Inclusion Criteria
- •Age 18 and older
- •Diagnosis of idiopathic Parkinson's disease.
- •Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state.
- •Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
- •Able to provide informed consent.
- •Appropriate social support
Exclusion Criteria
- •Hoehn and Yahr stage greater than 3 in the on medication state
- •Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
- •Any illness that in the investigator's opinion precludes participation in the study
- •Subjects unable to communicate with the investigator and staff
Outcomes
Primary Outcomes
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Time Frame: Baseline, 3 months
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points. A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.
Secondary Outcomes
- Levodopa Equivalent Daily Dose(Baseline, 3 months)
- Electroencephalography (EEG) Sensorimotor Relative Power Activity(Baseline, 3 months)