Parkinson Disease
Conditions
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.
Interventions
DEVICEStanford 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
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Age at the time of enrollment: 35 - 92 years 2. Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 3. Fluent in English 4. 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. 5. Feels comfortable going off PD related medication during in person study visits 6. Lives in the United States
Exclusion criteria
1. Any significant neuro-psychiatric problems, including acute confusional state, ongoing psychosis, or suicidal tendencies 2. Any current drug or alcohol abuse. 3. 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. 4. Pregnancy, breast-feeding or wanting to become pregnant 5. Craniotomy 6. Brain surgery 7. Patient is unable to communicate properly with staff (i.e., severe speech problems) 8. Excessive drooling 9. Patient is taking a medication that may cause significant withdrawal effects
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Contacts
Primary ContactJessica K Yankulova, MA
Backup ContactEllyn Daly
Outcome results
None listed