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

NCT03857867 | Terminated Results FDA Device

• 1 other identifier: IRB-47775
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

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

  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 Outcomes (2)

• Levodopa Equivalent Daily Dose

  Baseline, 3 months

• Electroencephalography (EEG) Sensorimotor Relative Power Activity

  Baseline, 3 months

Study Arms (1)

Tactile Stimulation Glove

EXPERIMENTAL

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

Device: Tactile Stimulation Glove

Interventions

Tactile Stimulation Glove DEVICE

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

Tactile Stimulation Glove

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peter Tass, MD, PhD: lead

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• 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.

  PMID: 33889086 RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

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

Limitations and Caveats

The study did not meet its accrual goal of 20 participants.

Results Point of Contact

• Title: Peter Tass
• Organization: Stanford

ptass@stanford.edu

650-304-8849

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Neurosurgery

Study Record Dates

• First Submitted: February 26, 2019
• First Posted: February 28, 2019
• Study Start: February 1, 2019
• Primary Completion: December 30, 2020
• Study Completion: December 30, 2020
• Last Updated: December 21, 2021
• Results First Posted: December 21, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)