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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06028477
• Other study ID #: 71954
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 29, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: October 2023
• Source: Stanford University
• Contact: Jessica Yankulova
• Phone: 650-474-9547
• Email: jessky[@]stanford.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: March 1, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 92 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Stanford Glove
The non-invasive neuromodulation hardware system comprises two wireless controllers/battery packs which are fastened to the top of each hand via an adjustable elastic strap. Each controller is equipped with four vibrotactile fingertip stimulators, also known as tappers. There is a total of eight tappers (for index, middle, ring and pinkie of each hand) per system.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and month 6