Vibrotactile Coordinated Reset: A Non-invasive Treatment for Parkinson's Disease

NCT04877015 | Terminated DMC FDA Device

• 1 other identifier: 59621
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our study is to evaluate Vibrotactile Coordinated Reset stimulation (vCR) and its effects on motor ability within Parkinson's patients. vCR will be administered with a device called the VT Brain Glove. vCR is expected to provide patients with a non-invasive alternative to the most widely used treatments such as levodopa and or deep brain stimulation. This study will include a dedicated sham that will aid in understanding true treatment effects from vCR.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Movement Disorders Society Unified Parkinson's Disease Rating Scale Part 3

  This scale measures motor ability within Parkinson's patients. For part 3, the scales minimum values is 0 and max value is 132. Higher scores indicate more impaired motor ability, while lower scores indicate less impaired motor ability. A score of 0 indicates no motor impairment. This evaluation will be done in person at baseline, 3,6 and 7 months. The remote version will be done at 10, 13 and 14 months

  14months

Secondary Outcomes (11)

• Spontaneous electroencephalography (EEG)

  7 months

• Sensorimotor task EEG

  7 months

• Vibration-only evoked EEG potentials

  7 months

• PD Quality of Life Questionnaire-39 (PDQ-39)

  14 months

• Parkinson's disease sleep scale (PDSS)

  14 months

Study Arms (2)

Active Vibrotactile Coordinated Reset (vCR)

ACTIVE COMPARATOR

Participants in this arm will receive active vCR stimulation.

Device: Active Vibrotactile Coordinated Reset (vCR)

Sham Vibrotactile Coordinated Reset (vCR)

SHAM COMPARATOR

Participants in this arm will receive sham vCR stimulation.

Device: Sham Vibrotactile Coordinated Reset (vCR)

Interventions

Active Vibrotactile Coordinated Reset (vCR) DEVICE

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. A specific pattern of vibration to each fingertip is delivered which theoretically disrupts abnormal synchrony in the brain.

Also known as: VT Brain Glove

Active Vibrotactile Coordinated Reset (vCR)

Sham Vibrotactile Coordinated Reset (vCR) DEVICE

Vibrotactile Coordinated Reset delivers vibratory stimulation to the fingertips of each hand. An inactive pattern of vibration to each fingertip is delivered which theoretically will not have the effects of active vCR.

Also known as: VT Brain Glove

Sham Vibrotactile Coordinated Reset (vCR)

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Presence of other forms of non-idiopathic parkinsonism, including but not limited to atypical parkinsonism, medication-induced parkinsonism, and vascular parkinsonism.
• Presence of other brain diseases (i.e. major depression, dementia, Attention Deficit/Hyperactivity Disorder (ADHD) psychosis, etc…).
• Severe depression, severe anxiety, or severe psychosis for the purpose of excluding candidates at an elevated risk of suicidal tendencies.
• Participation in another drug, device, biologic, or intervention trial concurrently or within the preceding 30 days.
• Physical limitations unrelated to Parkinson's disease.
• Speech problems or excessive drooling so severe patient cannot communicate properly to staff.
• Presences of dopamine dysregulation syndrome.
• On dopamine agonist(s) and exhibits compulsive behaviors.
• Current delirium
• Pregnancy, breastfeeding, or trying to get pregnant during the duration of the study.
• History of epilepsy or traumatic brain injury.
• Brain surgery (i.e. DBS implantation) or craniotomy.
• Neurostimulator.
• A type of hairstyle that would impede the use of a EEG cap
• Severe sensory abnormalities of the fingertips such as vibratory urticaria.

Sponsors & Collaborators

• Synergic Medical Technologies, Inc.: lead
• Stanford University: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

Related Publications (1)

• Pfeifer KJ, Cook AJ, Yankulova JK, Mortimer BJP, Erickson-DiRenzo E, Dhall R, Montaser-Kouhsari L, Tass PA. Clinical Efficacy and Dosing of Vibrotactile Coordinated Reset Stimulation in Motor and Non-motor Symptoms of Parkinson's Disease: A Study Protocol. Front Neurol. 2021 Nov 18;12:758481. doi: 10.3389/fneur.2021.758481. eCollection 2021.

  PMID: 34867742 DERIVED

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

Study Officials

• Peter Tass, MD PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: May 7, 2021
• Study Start: December 7, 2021
• Primary Completion: October 14, 2022
• Study Completion: October 14, 2022
• Last Updated: December 27, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)