Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population
Study Details
Study Description
Brief Summary
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.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Stimulation Patients will be asked to stimulate using a non invasive vibrotactile device. |
Device: Stanford Glove
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
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Outcome Measures
Primary Outcome Measures
- Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score [6 months]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age at the time of enrollment: 35 - 92 years
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Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to
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Fluent in English
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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.
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Feels comfortable going off PD related medication during in person study visits
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Lives in the United States
Exclusion Criteria:
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Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies
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Any current drug or alcohol abuse.
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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.
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Pregnancy, breast-feeding or wanting to become pregnant
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Craniotomy
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Brain surgery
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Patient is unable to communicate properly with staff (i.e., severe speech problems)
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Excessive drooling
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Patient is taking a medication that may cause significant withdrawal effects
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Stanford University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 71725