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

Synergic Medical Technologies

Status: Enrolling

Conditions: Parkinson's Disease

Treatments: Device: Sham vibrotactile coordinated reset; Device: Active Vibrotactile Coordinated Reset

Study type: Interventional

Funder types: Industry

Identifiers

NCT05830110

VCR-Longitudinal

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 45 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Active vibrotactile coordinated reset

Active Comparator group

Description:

mechanical vibrotactile stimulation to the fingers in a defined pattern

Treatment:

Device: Active Vibrotactile Coordinated Reset

Sham vibrotactile coordinated reset

Sham Comparator group

Description:

mechanical vibrotactile stimulation to the fingers in a defined pattern

Treatment:

Device: Sham vibrotactile coordinated reset