Vibrotactile Coordinated Reset for Parkinson's Patients of a More Variable Population

Stanford University

Status: Not yet enrolling

Conditions: Parkinson Disease

Treatments: Device: Stanford Glove

Study type: Interventional

Funder types: Other

Identifiers

NCT06029686

71725

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 35 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Stimulation

Experimental group

Description:

Patients will be asked to stimulate using a non invasive vibrotactile device.

Treatment:

Device: Stanford Glove