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

NCT ID: NCT06028477

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-10

Study Completion Date

2027-03-01

Brief Summary

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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

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Double blinded for 6 months followed by an unblinding of everyone with the exception of the clinical assessor

Study Groups

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Active stimulation

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

Group Type ACTIVE_COMPARATOR

Stanford Glove

Intervention Type 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.

Sham Stimulation

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

Group Type SHAM_COMPARATOR

Stanford Glove

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

92 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Vivek P. Buch

Assistant Professor of Neurosurgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vivek P Buch, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

Central Contacts

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Jessica Yankulova

Role: CONTACT

650-474-9547

Ellyn Daly

Role: CONTACT

Other Identifiers

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71954

Identifier Type: -

Identifier Source: org_study_id

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