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Active (not recruiting) Not applicable NCT05830110

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

No applicable phase (e.g. observational)
Conditions: Parkinson's Disease

Sponsor: Synergic Medical Technologies, Inc.

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
Active Vibrotactile Coordinated Reset
DEVICE
Sham vibrotactile coordinated reset
DEVICE
Locations 1
United States (1)
Synergic Medical Technologies
Eugene , Oregon
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
45 Years
Maximum age
90 Years
Healthy volunteers
No
Start date
01.03.2023
Completion date
01.06.2026
Registry ID
NCT05830110
Source
clinicaltrials.gov
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