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. 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
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.
Interventions
DEVICEStanford Glove
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.
Sponsors
Stanford University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor
Eligibility
Sex/Gender
ALL
Age
18 Years to 92 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score | Baseline and month 6 | 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 Yankulova
Backup ContactEllyn Daly
Outcome results
None listed