Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease

NCT05830110 | Active Not Recruiting FDA Device

• 1 other identifier: VCR-Longitudinal
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the present research is to examine the effectiveness of a non-invasive, vibrotactile stimulation protocol, known as coordinated reset (CR), for the alleviation of motor symptoms in patients with Parkinson's disease (PD). PD patients exhibit rigidity, slowness (bradykinesia) and poverty (akinesia) of movement as well as other symptoms. Treatment for PD is either pharmacological (first line) or invasive deep brain stimulation. The non-invasive, vibrotactile stimulation approach uses a novel stimulation pattern to disrupt the pathophysiological mechanism that is responsible for PD symptoms and thus restore motor function.

Conditions

Parkinson's Disease

Keywords

vibrotactile

Outcome Measures

Primary Outcomes (1)

• Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)

  Change in MDS-UPDRS score using Part 3 of the scale.

  baseline, 2 months, 4 months

Study Arms (2)

Active vibrotactile coordinated reset

ACTIVE COMPARATOR

mechanical vibrotactile stimulation to the fingers in a defined pattern

Device: Active Vibrotactile Coordinated Reset

Sham vibrotactile coordinated reset

SHAM COMPARATOR

mechanical vibrotactile stimulation to the fingers in a defined pattern

Device: Sham vibrotactile coordinated reset

Interventions

Active Vibrotactile Coordinated Reset DEVICE

Gloves providing vibrotactile coordinated reset stimulation

Active vibrotactile coordinated reset

Sham vibrotactile coordinated reset DEVICE

Gloves providing sham vibrotactile coordinated reset stimulation

Sham vibrotactile coordinated reset

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• between the ages 45 and 90
• diagnosis of bilateral, moderate stage idiopathic PD
• qualify for EEG procedures

You may not qualify if:

• on dopamine agonist medications and exhibiting compulsive behaviors

Sponsors & Collaborators

• Synergic Medical Technologies, Inc.: lead

Study Sites (1)

Synergic Medical Technologies

Eugene, Oregon, 97403, United States

Location

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

• Phan Luu, PhD

  Synergic Medical Technologies, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals.

Study Record Dates

• First Submitted: April 14, 2023
• First Posted: April 26, 2023
• Study Start: March 1, 2023
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)