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Behavioural Intervention
Rehab System for Vestibular Hypofunction (MINDGAPS Trial)
N/A
Recruiting
Research Sponsored by University of Montana
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 12 weeks
Awards & highlights
Summary
This trial tests the MINDGAPS system, a remote tool to help active-duty and Veteran Service Members with balance and psychological issues after a mild brain injury. It measures balance and visual stability to tailor treatments and track improvements. The goal is to enhance both physical and mental health in this specific group.
Who is the study for?
This trial is for veterans or active duty military members who can stand on their own and consent for themselves. It's not for those currently in physical therapy for balance/dizziness, with recent severe head injuries, blindness, certain eye or neck conditions, history of stroke/neurodegenerative diseases, or brain tumors.
What is being tested?
The study aims to set norms for inner ear function and psychological health measures and test the MINDGAPS system—a remote monitoring tool during rehab after concussions/mild Traumatic Brain Injury affecting vestibular health.
What are the potential side effects?
Since this trial involves rehabilitation exercises rather than medication, side effects may include temporary discomfort or dizziness during the exercises but will vary based on individual tolerance to physical therapy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through study completion, an average of 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Computerized Dynamic Visual Acuity (cDVA)
Secondary study objectives
Dizziness Handicap Inventory (DHI)
Functional Gait Assessment (FGA)
General Well Being Scale
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RehabExperimental Treatment1 Intervention
6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system
Group II: ObservationalActive Control1 Intervention
Normative data development of performance on vestibular measures following mTBI
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Vestibular Hypofunction include vestibular rehabilitation therapy (VRT), which involves specific exercises designed to promote central nervous system compensation for inner ear deficits. These exercises typically focus on improving gaze stability, balance, and vertigo symptoms through habituation, adaptation, and substitution techniques.
The mechanisms of action involve retraining the brain to use alternative sensory inputs and to better integrate vestibular information. This is crucial for patients as it helps reduce dizziness, improve balance, and enhance overall functional ability.
Remote monitoring systems like MINDGAPS can track progress in real-time, providing valuable feedback and allowing for adjustments in therapy to optimize outcomes.
Find a Location
Who is running the clinical trial?
United States Naval Medical Center, San DiegoFED
107 Previous Clinical Trials
22,200 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
54 Previous Clinical Trials
9,111 Total Patients Enrolled
University of MontanaLead Sponsor
25 Previous Clinical Trials
3,068 Total Patients Enrolled
1 Trials studying Vestibular Hypofunction
36 Patients Enrolled for Vestibular Hypofunction
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a spine disorder in my neck.I have been diagnosed with artery problems in my neck.I am legally able to make my own health decisions.I am getting physical therapy for balance or dizziness.I have been diagnosed with abnormal eye movements.I have had a stroke or have been diagnosed with a neurodegenerative disorder.I have had a brain tumor in the past.I can stand up on my own.I have had a serious head injury with loss of consciousness for over 30 minutes.
Research Study Groups:
This trial has the following groups:- Group 1: Rehab
- Group 2: Observational
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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