Vibrotactile Coordinated Reset for the Treatment of Post Surgery Refractory Parkinson's Disease Patients

Stanford University1 site in 1 country10 target enrollmentAugust 20, 2025

ConditionsParkinson Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Stanford University
Enrollment: 10
Locations: 1
Primary Endpoint: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on refractory post-surgery PD. 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.

Registry

clinicaltrials.gov

Start Date

August 20, 2025

End Date

November 21, 2026

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Peter Tass, MD, PhD

Protocol Director

Stanford University

Eligibility Criteria

Inclusion Criteria

•Age at the time of enrollment: 35 - 92 years
•Diagnosis of idiopathic Parkinson's disease
•Surgical treatment for Parkinson's disease that does not involve Deep Brain Stimulation
•Fluent in English
•Appropriate social support if required during an off state.
•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.
•Lives in the United States

Exclusion Criteria

•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
•Patient is unable to communicate properly with staff (i.e., severe speech problems)
•Excessive drooling
•Sensory abnormalities of the fingertips
•Deep Brain Stimulation treatment
•PD symptoms so severe and that the patient is bed-bound

Outcomes

Primary Outcomes

Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) change from baseline to 24 months.

Time Frame: 24 months

This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment.

Secondary Outcomes

Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change from baseline to 24 months.(24 months)
Parkinson's Disease-Cognitive Rating Scale (PDCRS) change from baseline to 24 months.(24 months)
Levodopa equivalent daily dose (LEDD) change from baseline to 24 months(24 months)
Communicative Participation Item Bank (CPIB; Short Form) change from baseline to 24 months.(24 months)
Freezing of gait questionnaire (FOG) change from baseline to 24 months(24 months)
Voice Handicap Index (VHI-10) change from baseline to 24 months(24 months)
Parkinson's disease cognitive functional rating scale (PD-CFRS) change from baseline to 24 months.(24 months)
Vibratory temporal discrimination task (VTDT) change from baseline to 24 months.(24 months)
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change from baseline to 24 months.(24 months)
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2 change from baseline to 24 months.(24 months)
Parkinsons disease quality of life questionnaire-39 (PDQ-39) change from baseline to 24 months(24 months)