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

Last updated: July 23, 2024
Sponsor: Synergic Medical Technologies, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Parkinson's Disease

Dyskinesias

Treatment

Active Vibrotactile Coordinated Reset

Sham vibrotactile coordinated reset

Clinical Study ID

NCT05830110
VCR-Longitudinal
  • Ages 45-90
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • between the ages 45 and 90

  • diagnosis of bilateral, moderate stage idiopathic PD

  • qualify for EEG procedures

Exclusion

Exclusion Criteria:

  • on dopamine agonist medications and exhibiting compulsive behaviors

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Active Vibrotactile Coordinated Reset
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
December 31, 2024

Study Description

Up to thirty adults with bilateral, moderate stage idiopathic PD will be enrolled in this longitudinal study. Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals. This longitudinal protocol will be open-ended to enable continued treatment to those interested / motivated.

Study treatment will consist of daily, four-hour vibrotactile Coordinated Reset (vCR) stimulation sessions on a continual basis. All daily vCR stimulation sessions will occur at the participant's home (ON-medication) and can be broken up into two, two-hour blocks (with no more than 12 hours between stimulation blocks) to be less cumbersome and better integrate into the participant's daily life. Daily home-based treatment will be unsupervised, though timely support is guaranteed by Synergic Medical Technologies (SMT) support staff when needed (e.g., when usability or IT issues arise). Daily stimulation / device usage will be automatically logged by the device and continuously monitored by SMT staff, meanwhile participants will keep a med diary so we can monitor their med usage (and how it relates to extended exposure) over time. Participants will be able to transition to an as-needed basis with treatment after four months and once they are familiar with the treatment and their body's response to it, to better alleviate PD symptoms.

Connect with a study center

  • Synergic Medical Technologies

    Eugene, Oregon 97403
    United States

    Active - Recruiting

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