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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05830110
• Other study ID #: VCR-Longitudinal
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Synergic Medical Technologies, Inc.
• Contact: Elyria Kabasenche, BS
• Phone: 541-510-7068
• Email: elyria.kabasenche[@]synergicmed.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• Active Vibrotactile Coordinated Reset
Gloves providing vibrotactile coordinated reset stimulation
• Sham vibrotactile coordinated reset
Gloves providing sham vibrotactile coordinated reset stimulation

Locations

Country	Name	City	State
United States	Synergic Medical Technologies	Eugene	Oregon

Sponsors (1)

Lead Sponsor	Collaborator
Synergic Medical Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)	Change in MDS-UPDRS score using Part 3 of the scale.	baseline, 2 months, 4 months