Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study

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. 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
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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.

Official Title
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Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study

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: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 92 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active stimulation<br>Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR | Device: Stanford Glove<br>* The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.<br>|
| Sham Comparator: Sham Stimulation<br>Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR | Device: Stanford Glove<br>* The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline and month 6 |