RecruitingNot Applicable

Improving Psychological and Vestibular Health: MINDGAPS

United States500 participantsStarted 2023-08-30

Plain-language summary

The purpose of this study is twofold: 1) Develop norms for measures of inner ear function and psychological health, and 2) Examine the feasibility of using the MINDGAPS system (a remote monitoring system) to track progress during physical therapy or rehabilitation for inner ear problems following a concussion or mild Traumatic Brain Injury.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Veteran or Active Duty Military Service Member * Ability to stand independently * Legally autonomous and able to self-consent Exclusion Criteria: * Acute head injury (within the previous 2 months) * History of moderate or severe head injury (i.e., loss of consciousness greater than 30 minutes or post-traumatic amnesia greater than 1 day) * Current diagnosis of spine disorders in the neck * Diagnosis of problems with the arteries in your neck * Blindness * If you have been diagnosed with abnormal eye movements (also called "ocular motor palsy") * If you have previously had a stroke or been diagnosed with a neurodegenerative disorder ( e.g., Parkinson's Disease, Multiple Sclerosis) * If you have been previously diagnosed primary vestibular dysfunction ( e.g., congenital peripheral vestibular syndrome) * If you have previously been diagnosed with a brain tumor * If you are currently receiving physical therapy care for balance or dizziness problems

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Computerized Dynamic Visual Acuity (cDVA)

Timeframe: through study completion, an average of 12 weeks

Trial details

NCT IDNCT05986279

SponsorUniversity of Montana

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-09-29

Contact for this trial

Brian Loyd, PhD

406-243-4015 Brian.loyd@umontana.edu

View on ClinicalTrials.gov More Vestibular Hypofunction trials