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

NCT06029686 | Not Yet Recruiting FDA Device

• 1 other identifier: 71725
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Stimulation

EXPERIMENTAL

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

Device: Stanford Glove

Interventions

Stanford Glove 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

Stimulation

Eligibility Criteria

• Age: 35 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age at the time of enrollment: 35 - 92 years
• Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to
• 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.
• Feels comfortable going off PD related medication during in person study visits
• Lives in the United States

You may not qualify if:

• 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
• Craniotomy
• Brain surgery
• Patient is unable to communicate properly with staff (i.e., severe speech problems)
• Excessive drooling
• Patient is taking a medication that may cause significant withdrawal effects

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Peter A Tass, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica K Yankulova, MA

CONTACT

6504749547; jessky@stanford.edu

Ellyn Daly

CONTACT

6509450174; ellynd@stanford.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)