Improving psychological and vestibular health with MINDGAPS
Improving Psychological and Vestibular Health Using a Novel Intervention: The Making Informed Decisions in Gaze and Postural Stability (MINDGAPS) System
This study is testing a new system called MINDGAPS to see if it can help track recovery and improve both balance and mental health in people who have dizziness and anxiety after a mild brain injury.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Montana Academic / other |
| Locations | 2 sites (San Diego, California and 1 other locations) |
| Trial ID | NCT05986279 on ClinicalTrials.gov |
What this trial studies
This project aims to develop norms for assessing inner ear function and psychological health while evaluating the feasibility of the MINDGAPS system for tracking rehabilitation progress in patients with vestibular issues following mild traumatic brain injury. The study explores the connection between vestibular disturbances, such as dizziness and balance issues, and psychological health problems like anxiety and depression. By utilizing objective measures of dynamic visual acuity and postural sway, the MINDGAPS system personalizes treatment programs and monitors patient progress effectively. The research aligns with the Traumatic Brain Injury and Psychological Health Research Program to enhance understanding and treatment of these interconnected conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are veterans or active duty military service members who can stand independently and are legally able to self-consent.
Not a fit: Patients with recent acute head injuries, severe head injuries, or existing neurological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved rehabilitation strategies for patients suffering from vestibular disturbances and associated psychological issues.
How similar studies have performed: Other studies have shown promise in addressing vestibular health and psychological well-being, but the specific approach of using the MINDGAPS system is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
San Diego, California and 1 other locations
- Naval Medical Center San Diego — San Diego, California, United States (Recruiting)
- University of Montana — Missoula, Montana, United States (Recruiting)
Study contacts
- Study coordinator: Brian Loyd, PhD
- Email: Brian.loyd@umontana.edu
- Phone: 406-243-4015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.