Patterned Multichannel Vibrotactile Stimulation for the Longitudinal Treatment of Moderate Stage Parkinson's Disease
NCT ID: NCT05830110
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2023-03-01
2024-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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Active vibrotactile coordinated reset
mechanical vibrotactile stimulation to the fingers in a defined pattern
Active Vibrotactile Coordinated Reset
Gloves providing vibrotactile coordinated reset stimulation
Sham vibrotactile coordinated reset
mechanical vibrotactile stimulation to the fingers in a defined pattern
Sham vibrotactile coordinated reset
Gloves providing sham vibrotactile coordinated reset stimulation
Interventions
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Active Vibrotactile Coordinated Reset
Gloves providing vibrotactile coordinated reset stimulation
Sham vibrotactile coordinated reset
Gloves providing sham vibrotactile coordinated reset stimulation
Eligibility Criteria
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Inclusion Criteria
* diagnosis of bilateral, moderate stage idiopathic PD
* qualify for EEG procedures
Exclusion Criteria
45 Years
90 Years
ALL
No
Sponsors
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Synergic Medical Technologies, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Phan Luu, PhD
Role: PRINCIPAL_INVESTIGATOR
Synergic Medical Technologies, Inc.
Locations
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Synergic Medical Technologies
Eugene, Oregon, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VCR-Longitudinal
Identifier Type: -
Identifier Source: org_study_id
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