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

Overview

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.

Full Title of Study: “A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson’s Disease”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: September 30, 2019

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. Participants will either be randomized to receive the real stimulation, or fake ("sham") stimulation. This will help investigators compare durability and efficacy of the tactile stimulation to current medical therapy. Participants randomized to the "sham" arm will be allowed to receive the real stimulation after 3 months of follow-up. All patients will be followed for total of 6 months (both real and sham stimulation groups). 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.

Interventions

  • Device: Tactile Stimulation Glove
    • A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson’s patients.
  • Device: Sham Stimulation Glove
    • Sham Device to mimic tactile stimulation glove.

Arms, Groups and Cohorts

  • Experimental: Tactile Stimulation Glove
    • Patients will receive actual tactile stimulation. They will be blinded to this randomization until month 3.
  • Sham Comparator: Sham Stimulation Glove
    • Patients will receive “sham” tactile stimulation. They will be blinded to this randomization until month 3 and will be able to receive the real stimulation glove at month 3.

Clinical Trial Outcome Measures

Primary Measures

  • Change in 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.

Secondary Measures

  • Parkinson’s Medication
    • Time Frame: Up to 6 months
    • Changes in medication will be measured in levodopa dose equivalency
  • Change in MDS-UPDRS part III Score
    • Time Frame: Baseline, 6 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.

Participating in This Clinical Trial

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 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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Casey H. Halpern
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Casey H. Halpern, Assistant Professor of Neurosurgery, Director of Epilepsy Surgery – Stanford University
  • Overall Official(s)
    • Casey H Halpern, MD, Principal Investigator, Stanford University

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