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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06029686
• Other study ID #: 71725
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2024
• Est. completion date: January 2026

Study information

• Verified date: February 2024
• Source: Stanford University
• Contact: Jessica K Yankulova, MA
• Phone: 6504749547
• Email: jessky[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: January 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• 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

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score	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.	6 months