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

NCT ID: NCT06029686

Last Updated: 2024-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2027-01-31

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Stimulation

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

Group Type: EXPERIMENTAL

Stanford Glove

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Vivek P. Buch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter A Tass, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Stanford, California, United States

Countries

United States

Central Contacts

Jessica K Yankulova, MA

Role: CONTACT

jessky@stanford.edu

6504749547

Ellyn Daly

Role: CONTACT

ellynd@stanford.edu

6509450174

Other Identifiers

71725

Identifier Type: -

Identifier Source: org_study_id