Improving Psychological and Vestibular Health Using a Novel Intervention: The Making Informed Decisions in Gaze and Postural Stability (MINDGAPS) System
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Montana
- Enrollment
- 500
- Locations
- 4
- Primary Endpoint
- Computerized Dynamic Visual Acuity (cDVA)
Study Overview
Brief 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.
Detailed Description
The intersection between vestibular disturbance and psychological health provides a unique clinical opportunity to address both the modifiable symptoms of vestibular disturbance as well as psychological health. This project aims to advance our understanding of the causal link between vestibular disturbance and poor psychological health and aligns directly with the Traumatic Brain Injury and Psychological Health Research Program (Funding Opportunity: W81XWH-21-TBIPHRP-TRA). Specifically, the proposed research is responsive to each of the three focus areas: Understand- this project is designed to advance the understanding of an established link between vestibular disturbance (e.g., dizziness and poor balance) and poor psychological health (e.g., anxiety, depression, and social isolation) in survivors of mild traumatic brain injury (mTBI). Prevent- the MINDGAPS system allows for precise assessment of dynamic visual acuity (computerized dynamic visual acuity [cDVA]) and postural sway (instrumented balance accelerometry measure [iBAM]), two objective and extensively validated surrogates of vestibular health. Additionally, MINDGAPS uses these measures to inform care decisions via a user-friendly web application. Treat- vestibular assessment is key to effective vestibular care, as it allows for personalization of treatment programs and monitoring progress over time.
Objective/Hypothesis:
The overall objective of this project is two-fold: 1) Test the preliminary efficacy of the MINDGAPS system to improve psychological health and vestibular disturbance in active-duty and Veteran Service Members (SM) with history of mTBI and 2) refine the MINDGAPS system by developing military-specific normative data and using Community-Based Participatory Research (CBPR) to incorporate the lived experiences of mTBI survivors, their caregivers, and clinicians in the design of the MINDGAPS technology and intervention.
Specific Aims:
Specific Aim 1 (Preliminary Efficacy): Examine the preliminary efficacy of the MINDGAPS system to improve psychological and vestibular health in active-duty and Veteran SM with sub-acute and chronic mTBI.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Computerized Dynamic Visual Acuity (cDVA)
Time Frame: through study completion, an average of 12 weeks
computerized measure of functional gaze stability
Secondary Outcomes
- Video head impulse testing (vHIT)(through study completion, an average of 12 weeks)
- Dizziness Handicap Inventory (DHI)(through study completion, an average of 12 weeks)
- Life Space Mobility Assessment (LSA)(through study completion, an average of 12 weeks)
- Ohio State University Head Injury History(through study completion, an average of 12 weeks)
- Primary Care 5-Item PTSD Screen(through study completion, an average of 12 weeks)
- Instrumented postural sway assessment(through study completion, an average of 12 weeks)
- Role Participation Questionnaire(through study completion, an average of 12 weeks)
- Military Service Information (MSI)(through study completion, an average of 12 weeks)
- General Well Being Scale(through study completion, an average of 12 weeks)
- Functional Gait Assessment (FGA)(through study completion, an average of 12 weeks)
- Healthcare Utilization Questionnaire(through study completion, an average of 12 weeks)
- Self-Administered Comorbidity Questionnaire (SCQ)(through study completion, an average of 12 weeks)
- Visual Analogy Scale of Dizziness and Unsteadiness(through study completion, an average of 12 weeks)
- High-Level Mobility Assessment (HiMT)(through study completion, an average of 12 weeks)
Investigators
Brian Loyd
Professor
University of Montana