Vibrotactile Coordinated Reset in Parkinson's Disease - Proof of Concept Study

Not Applicable

Not yet recruiting

• Conditions: Parkinson Disease
• Interventions: Device: Stanford Glove

• Registration Number: NCT06028477
• Lead Sponsor: Stanford University

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on Parkinson's symptoms. 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 14 months.

Detailed Description

The purpose of this study is to test the efficacy of vibrotactile coordinated reset stimulation on human subject participants with Parkinson's disease and inform the investigators on whether unilateral stimulation could be as effective as bilateral stimulation at producing clinically significant improvements in symptoms.

Study Timeline

• Study First Submitted: 2023-08-31
• Study First Submitted QC: 2023-08-31
• Study First Posted: 2023-09-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Study Start: 2025-01-10
• Primary Completion: 2026-12-30
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

Ages 18 or older

• Diagnosed with idiopathic Parkinson's Disease
• Fluent in English
• Off-state UPDRS III motor score at least 30, as assessed within the past 6 months before study consent or at Screening Visit.
• Demonstrates understanding of the study requirements and is able and willing to sign the informed consent form and complete study procedures.

Exclusion Criteria

• 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
• Has implantation of a medical device
• Sensory abnormalities of the fingertips

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active stimulation	Stanford Glove	Participants will receive active stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR
Sham Stimulation	Stanford Glove	Participants will receive sham stimulation between 2 hours minimum and 4 hours maximum of daily vCR or sham stimulation (2 hours twice daily) at home for the first month (30 days), followed by a minimum of 1.5 hours and a maximum of 2.5 hours of daily vCR

Primary Outcome Measures

Name	Time	Method
Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score	Baseline and month 6	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States