Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Vibrotactile Coordinated Reset
Sham vibrotactile coordinated reset
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring vibrotactile
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
Sites / Locations
- Synergic Medical TechnologiesRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active vibrotactile coordinated reset
Sham vibrotactile coordinated reset
Arm Description
mechanical vibrotactile stimulation to the fingers in a defined pattern
mechanical vibrotactile stimulation to the fingers in a defined pattern
Outcomes
Primary Outcome Measures
Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)
Change in MDS-UPDRS score using Part 3 of the scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT05830110
First Posted
April 14, 2023
Last Updated
April 25, 2023
Sponsor
Synergic Medical Technologies, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT05830110
Brief Title
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
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Synergic Medical Technologies, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
vibrotactile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Participants will serve as their own control, receiving alternating active and sham therapy at two-month intervals.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active vibrotactile coordinated reset
Arm Type
Active Comparator
Arm Description
mechanical vibrotactile stimulation to the fingers in a defined pattern
Arm Title
Sham vibrotactile coordinated reset
Arm Type
Sham Comparator
Arm Description
mechanical vibrotactile stimulation to the fingers in a defined pattern
Intervention Type
Device
Intervention Name(s)
Active Vibrotactile Coordinated Reset
Intervention Description
Gloves providing vibrotactile coordinated reset stimulation
Intervention Type
Device
Intervention Name(s)
Sham vibrotactile coordinated reset
Intervention Description
Gloves providing sham vibrotactile coordinated reset stimulation
Primary Outcome Measure Information:
Title
Movement Disorder Society - Change in Universal Parkinson Disease Rating Scale (MDS-UPDRS)
Description
Change in MDS-UPDRS score using Part 3 of the scale.
Time Frame
baseline, 2 months, 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elyria Kabasenche, BS
Phone
541-510-7068
Email
elyria.kabasenche@synergicmed.com
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Gaston, PhD
Phone
5412289691
Email
barbara.gaston@synergicmed.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Phan Luu, PhD
Organizational Affiliation
Synergic Medical Technologies, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Synergic Medical Technologies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elyria Kabasenche, BS
Phone
541-510-7068
Email
elyria.kabasenche@synergicmed.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
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