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

Not Applicable

Terminated

• Conditions: Parkinson Disease
• Interventions: Device: Tactile Stimulation Glove

• Registration Number: NCT03857867
• Lead Sponsor: Peter Tass, MD, PhD

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.

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 Timeline

• Study Start: 2019-02-01
• Study First Submitted: 2019-02-26
• Study First Submitted QC: 2019-02-26
• Study First Posted: 2019-02-28
• Primary Completion: 2020-12-30
• Study Completion: 2020-12-30
• Results First Submitted: 2021-10-21
• Status Verified: 2021-11
• Results First Submitted QC: 2021-11-22
• Last Update Submitted: 2021-11-22
• Results First Posted: 2021-12-21
• Last Update Posted: 2021-12-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tactile Stimulation Glove	Tactile Stimulation Glove	Patient will receive active stimulation for a minimum of 3 months and a maximum of 13 months

Primary Outcome Measures

Name	Time	Method
Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III Score	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

Name	Time	Method
Levodopa Equivalent Daily Dose	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.
Electroencephalography (EEG) Sensorimotor Relative Power Activity	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.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States