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NCT Number: NCT05830110

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

45 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Synergic Medical Technologies

Eugene, Oregon, 97403, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • on dopamine agonist medications and exhibiting compulsive behaviors

Treatment and study plan

Active Vibrotactile coordinated reset

Device

Gloves providing vibrotactile coordinated reset stimulation

Sham vibrotactile coordinated reset

Device

Gloves providing sham vibrotactile coordinated reset stimulation

Primary outcomes

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

    Time frame: baseline, 2 months, 4 months

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

Sponsors and collaborators

Lead sponsor

Synergic Medical Technologies, Inc.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 26, 2023
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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