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

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year–92 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stanford University

Stanford, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stanford Glove

Device

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.

Primary outcomes

Change in MDS-Unified Parkinson's Disease Rating Scale Part III Scale Score

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ellyn Daly

CONTACT

[email protected]

Jessica Yankulova

CONTACT

[email protected]

650-474-9547

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2027
First posted: Sep 8, 2023
Registry last updated: Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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