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

Not Applicable

Not yet recruiting

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

• Registration Number: NCT06029686
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-01
• Study First Submitted QC: 2023-09-01
• Study First Posted: 2023-09-08
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-15
• Last Update Posted: 2024-08-19
• Study Start: 2025-05
• Primary Completion: 2026-12
• Study Completion: 2027-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stimulation	Stanford Glove	Patients will be asked to stimulate using a non invasive vibrotactile device.

Primary Outcome Measures

Name	Time	Method
Change in Parkinsonian symptoms as defined by the change in Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III Score	6 months	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States