Evaluation of Using Vibrotactile Coordinated Reset for Management of Parkinson's Disease
November 22, 2021 updated by: Peter Tass, MD, PhD
A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
7
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
-
Stanford, California, United States, 94305
- Stanford University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 and older
- Diagnosis of idiopathic Parkinson's disease.
- 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.
- Willing to participate in the vibrotactile stimulation sessions for 2 consecutive days initially and willing to return for follow-up visits
- Able to provide informed consent.
- Appropriate social support
Exclusion Criteria:
- Hoehn and Yahr stage greater than 3 in the on medication state
- Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication induced parkinsonism, vascular Parkinsonism
- Any illness that in the investigator's opinion precludes participation in the study
- Subjects unable to communicate with the investigator and staff
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Tactile Stimulation Glove
Patient will receive active stimulation for a minimum of 3 months and a maximum of 13 months
|
A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score
Time Frame: Baseline, 3 months
|
The MDS-UPDRS III is the sum of 33 scores that evaluate Parkinson's disease motor symptoms on a scale from 0 to 4 points.
A score of 0 indicated no symptom is present and a maximum score of 4 indicates the most severe symptom, the total scale range is 0-132, where higher scores indicate more severe symptoms.
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Levodopa Equivalent Daily Dose
Time Frame: Baseline, 3 months
|
Levodopa equivalent daily dose (LEDD) was measured at baseline and after 3 months of vibrotactile coordinated reset therapy.
LEDD is calculated as a sum of each Parkinson's medication.
|
Baseline, 3 months
|
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Electroencephalography (EEG) Sensorimotor Relative Power Activity
Time Frame: Baseline, 3 months
|
Measure Description: Baseline EEG was recorded.
EEG source estimation was computed using Standardized low-resolution brain electromagnetic tomography analysis (sLORETA) and was restricted to the sensorimotor region.
Power spectral density (PSD) was calculated for each frequency band (Delta: 2-4 Hz; Theta: 5-7 Hz; Alpha: 8-12 Hz; Low Beta: 13-16 Hz; Mid Beta: 17-20 Hz; High Beta: 21-30 Hz; Gamma: 31-50 Hz).
Relative power (RP) was calculated by taking the sum of each frequency and dividing it by the total power (2-50 Hz) expressed as a percentage.
High beta power was the frequency band of interest for analysis.
|
Baseline, 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2019
Primary Completion (Actual)
December 30, 2020
Study Completion (Actual)
December 30, 2020
Study Registration Dates
First Submitted
February 26, 2019
First Submitted That Met QC Criteria
February 26, 2019
First Posted (Actual)
February 28, 2019
Study Record Updates
Last Update Posted (Actual)
December 21, 2021
Last Update Submitted That Met QC Criteria
November 22, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB-47775
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.