Improving Psychological and Vestibular Health: MINDGAPS
NCT ID: NCT05986279
Last Updated: 2024-12-06
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
500 participants
INTERVENTIONAL
2023-08-30
2027-09-29
Brief Summary
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Detailed Description
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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.
Specific Aim 2 (Military-specific Normative Data): Collect a cross-sectional sample of cDVA, iBAM, and other relevant measures in active-duty and Veteran Service Members across three different stages of mTBI-no diagnosed history of mTBI, sub-acute mTBI (2-6 months), and chronic mTBI (\>6 months)-for the development of normative values in military-specific populations.
Specific Aim 3 (Refinement of MINDGAPS): Utilize CBPR to refine and improve the MINDGAPS system for different stakeholders (SM, caregivers, and clinicians) and position MINDGAPS for examination in a large-scale clinical trial as well as translation into clinical practice.
Study Design:
Aim 1: Using a single-cohort (N=36) double-baseline design, all participants will be tested twice during a no-intervention baseline period, then once following a 6-week course of vestibular training with the MINDGAPS system. Efficacy will be determined by comparing change during the baseline period to change over the course of the intervention period. Aim 2: A large sample of active-duty and Veteran SM (N=300) will be tested in a single, cross-sectional assessment to build military-specific normative vestibular data. Aim 3: We will use a convergent mixed-methods analysis of study participant feedback, in combination with quantitative results and stakeholder engagement, to drive refinement of the MINDGAPS system throughout the study period.
Impact:
Signs of vestibular disturbance are the most commonly reported symptoms following mTBI, and vestibular disturbance is causally implicated in the development of poor psychological health following mTBI. Interventions aimed at improving vestibular disturbance can improve debilitating symptoms such as poor balance and dizziness. The completion of this study will move MINDGAPS to a technology readiness level of 8, preparing it to be studied in a large clinical trial in the next phase of work.
Relevance to Military Health:
Interventions aimed at improving vestibular disturbance would have profound impacts on both active-duty SM (inability to visually focus during dynamic tasks- e.g., field of fire) and Veterans (increased risk of falls). Furthermore, the MINDGAPS system enables rapid and precise assessment of vestibular functioning at low cost and therefore has tremendous potential to enhance the delivery of clinical services within a number of active-duty environments including far-forward military settings or Veterans living in rural areas.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rehab
6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system
Rehab
6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system
Observational
Normative data development of performance on vestibular measures following mTBI
No interventions assigned to this group
Interventions
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Rehab
6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system
Eligibility Criteria
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Inclusion Criteria
* Ability to stand independently
* Legally autonomous and able to self-consent
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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United States Naval Medical Center, San Diego
FED
Congressionally Directed Medical Research Programs
FED
University of Montana
OTHER
Responsible Party
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Brian Loyd
Professor
Locations
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Naval Medical Center San Diego
San Diego, California, United States
University of Montana
Missoula, Montana, United States
Countries
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Central Contacts
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Facility Contacts
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Trevor Kingsbury
Role: primary
Brian Loyd, PhD
Role: primary
Andy Kittelson, PhD
Role: backup
Other Identifiers
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168-22
Identifier Type: -
Identifier Source: org_study_id