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Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease

NCT ID: NCT03857867

Last Updated: 2021-12-21

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2020-12-30

Brief Summary

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This is a study to evaluate peripheral vibrotactile coordinated reset stimulation for Parkinson's disease seeks to explore the safety and efficacy of an experimental non-invasive method to aid in the symptoms of Parkinson's disease. The purpose of the study is to verify the safety and tolerability of non-painful sensory (tactile) vibratory stimulation delivered to the fingertips of patients with Parkinson's disease.

Detailed Description

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This study aims to evaluate the safety and efficacy of a non-invasive, experimental method to aid in the symptoms of Parkinson's disease. A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients. Vibrotactile coordinated reset (vCR) will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants will receive vCR for a minimum of 3 months and a maximum of 13 and motor ability will be recorded. If the results of this study suggest that vibrotactile CR stimulation is safe and effective for the treatment of Parkinson's disease, this non-invasive treatment approach would have a substantial impact on Parkinson's disease.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tactile Stimulation Glove

Patient will receive active stimulation for a minimum of 3 months and a maximum of 13 months

Group Type EXPERIMENTAL

Tactile Stimulation Glove

Intervention Type DEVICE

A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.

Interventions

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Tactile Stimulation Glove

A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Age 18 and older
2. Diagnosis of idiopathic Parkinson's disease.
3. Levodopa responsiveness as defined by at least a 30% reduction in Movement Disorders Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) motor subscale (excluding tremor scores) in the ON vs off medication state.
4. Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
5. Able to provide informed consent.
6. Appropriate social support

Exclusion Criteria

1. Hoehn and Yahr stage greater than 3 in the on medication state
2. Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
3. Any illness that in the investigator's opinion precludes participation in the study
4. Subjects unable to communicate with the investigator and staff
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peter Tass, MD, PhD

OTHER

Sponsor Role lead

Responsible Party

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Peter Tass, MD, PhD

Professor of Neurosurgery

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

References

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Pfeifer KJ, Kromer JA, Cook AJ, Hornbeck T, Lim EA, Mortimer BJP, Fogarty AS, Han SS, Dhall R, Halpern CH, Tass PA. Coordinated Reset Vibrotactile Stimulation Induces Sustained Cumulative Benefits in Parkinson's Disease. Front Physiol. 2021 Apr 6;12:624317. doi: 10.3389/fphys.2021.624317. eCollection 2021.

Reference Type RESULT
PMID: 33889086 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IRB-47775

Identifier Type: -

Identifier Source: org_study_id