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

• ClinicalTrials.gov Identifier: NCT03857867
• Recruitment Status: Terminated
• First Posted: February 28, 2019
• Results First Posted: December 21, 2021
• Last Update Posted: December 21, 2021
• Sponsor: Peter Tass, MD, PhD
• Information provided by (Responsible Party): Peter Tass, MD, PhD, Stanford University

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Parkinson Disease	Device: Tactile Stimulation Glove	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 7 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Prospective, Randomized, Staggered-onset, Double Blinded, Sham-Controlled Study to Evaluate Peripheral Vibrotactile Coordinated Reset (CR) Stimulation for Parkinson's Disease
• Actual Study Start Date: February 1, 2019
• Actual Primary Completion Date: December 30, 2020
• Actual Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Tactile Stimulation Glove; Patient will receive active stimulation for a minimum of 3 months and a maximum of 13 months	Device: Tactile Stimulation Glove; A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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.
2. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

Stanford University

Stanford, California, United States, 94305

Sponsors and Collaborators

Peter Tass, MD, PhD

  Study Documents (Full-Text)

Documents provided by Peter Tass, MD, PhD, Stanford University:

Study Protocol and Statistical Analysis Plan  [PDF] October 1, 2018

More Information

Publications of Results:

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.

• Responsible Party: Peter Tass, MD, PhD, Professor of Neurosurgery, Stanford University
• ClinicalTrials.gov Identifier: NCT03857867
• Other Study ID Numbers: IRB-47775
• First Posted: February 28, 2019
• Results First Posted: December 21, 2021
• Last Update Posted: December 21, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

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