Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population

Study Overview
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Brief Summary
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The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms of a more variable population. 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 two years.

Official Title
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Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: Stanford Glove


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at the time of enrollment: 35 - 92 years Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to Fluent in English Comfortable with technology; can use a computer, check email, and access the internet; can initiate and engage in a virtual meeting for training and monitoring purposes. Feels comfortable going off PD related medication during in person study visits Lives in the United States Exclusion Criteria: Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies Any current drug or alcohol abuse. 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 Craniotomy Brain surgery Patient is unable to communicate properly with staff (i.e., severe speech problems) Excessive drooling Patient is taking a medication that may cause significant withdrawal effects

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stimulation<br>Patients will be asked to stimulate using a non invasive vibrotactile device. | Device: Stanford Glove<br>* The vibrotactile device sends weak non-painful pattern type vibratory stimulus to the fingertips and is non-invasive. Some patient may experience dyskinesia which can me medicated with a decrease in Parkinson's medication<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score | Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score 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. | 6 months |