Vibrotactile Coordinated Reset for the Treatment of Advanced Parkinson's Disease Patients Who Have Previously Received vCR Stimulation

Stanford University0 sites5 target enrollmentJanuary 2025

ConditionsParkinson Disease

Overview

Phase: N/A
Intervention: Not specified
Conditions: Parkinson Disease
Sponsor: Stanford University
Enrollment: 5
Primary Endpoint: Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication
Status: Not Yet Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with advanced stage Parkinson's Disease who have previously received vCR therapy.

Registry

clinicaltrials.gov

Start Date

January 2025

End Date

September 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Stanford University

Responsible Party

Principal Investigator

Vivek P. Buch

Stanford University

Eligibility Criteria

Inclusion Criteria

•Any adult age 18 and older
•Idiopathic Parkinson's Symptoms between Hoehn and Yahr stages 2 to 4
•Fluent in English
•If patient is on medication that affects brain function or alters EEG activity, the patient must feel comfortable going off this medication prior to EEG recording
•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.
•Feels comfortable going off PD related medication during in person study visits
•Lives in the United States
•Having previously been enrolled in a vCR pilot study

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
•Physical limitations unrelated to PD that would affect motor ratings
•Craniotomy
•Brain surgery
•Patient is unable to communicate properly with staff (i.e., severe speech problems)
•Excessive drooling
•A type of hairstyle that would impede the use of an EEG cap

Outcomes

Primary Outcomes

Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3 (MDS-UPDRS III) off medication

Time Frame: Baseline, 3Months,6 Months, 9 Months 12 Months, 18 Months, 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

Levodopa equivalent daily dose (LEDD) daily change from baseline to 24 months(24 months)
Parkinson's disease quality of life questionnaire-39 (PDQ-39)(24 months)
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 2(24 months)
Freezing of Gait Questionnaire (FOG) change(24 months)
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 1 change(24 months)
Movement disorders unified Parkinson's rating scale (MDS-UPDRS) part 4 change(24 months)
Communicative Participation Item Bank (CPIB; Short Form)(24 months)
Voice Handicap Index (VHI-10)(24 months)
Spontaneous Electroencephalography beta band power change(24 months)
Parkinson's disease cognitive functional rating scale (PD-CFRS)(24 months)
Device calibration(24 months)