Clinical trial NCT05830110: Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
Official title: Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Keywords: vibrotactile
Lead sponsor: Synergic Medical Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2023-04-26
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)
timeFrame: baseline, 2 months, 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Synergic Medical Technologies
state: Oregon
Study officials:
affiliation: Synergic Medical Technologies, Inc.
name: Phan Luu, PhD
role: PRINCIPAL_INVESTIGATOR
References: