Patterned Multichannel Vibrotactile Stimulation for the Longitudinal

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05830110
Study type	Interventional
Source	Synergic Medical Technologies, Inc.
Contact	Elyria Kabasenche, BS
Phone	541-510-7068
Email	elyria.kabasenche@synergicmed.com
Status	Recruiting
Phase	N/A
Start date	June 1, 2019
Completion date	December 2024

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms