Parkinson Disease, Idiopathic
Conditions
Keywords
vibrotactile, vibrotactile coordinated reset, parkinsons disease
Brief summary
The purpose of this clinical trial is to test the efficacy of vibrotactile coordinated reset stimulation to improve movement ability and other symptoms of human subject participants with Parkinsons Disease who take dopaminergic medication and are unable to withhold this medication. Participants will be followed for five years and make a total of five study visits.
Interventions
The Stanford CR glove is designed to administer vibrotactile coordinated reset stimulation, which consists of vibratory stimulation of the fingertips delivered in a specific pattern which is design to disrupt and normalize abnormal brain synchrony.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age at the time of enrollment: Adults 18 and older * Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4 * 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. * 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. * Patient is unable to communicate properly with staff (i.e., severe speech problems). * Excessive drooling
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS Part 3 | Baseline, 6 months, 12 months, 18 months, 24 months | The Movement Disorder Society Unified Parkinsons Disease Rating Scale Part 3 assessment, obtained while the participant is off medication, is a scale that measures motor ability within Parkinsons patients. For part 3, the scales minimum values are 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. |
Contacts
Primary ContactJessica Yankulova
Backup ContactEllyn Daly
Outcome results
None listed