Improving Psychological and Vestibular Health: MINDGAPS

Part of paid clinical trials in San Diego, California.

Sponsor
University of Montana
Study ID
NCT05986279
Status
Recruiting
Apply to this trial

Conditions

  • Vestibular Hypofunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Rehab — OTHER
    6 weeks of vestibular rehabilitation guided by the MINDGAPS decision support system

Study Details

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.

Key Dates

Start date
Aug 30, 2023
Status verified
Dec 2024
Primary completion
Sep 29, 2027
Completion
Sep 29, 2027

Study Design

Enrollment
500 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Rehab
    6 weeks of vestibular physical therapy guided by the use of the MINDGAPS decision support system
  • No Intervention: Observational
    Normative data development of performance on vestibular measures following mTBI

Primary Outcome Measure

Computerized Dynamic Visual Acuity (cDVA) [ Time Frame: through study completion, an average of 12 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Naval Medical Center San DiegoSan DiegoCalifornia92134
Trevor Kingsbury
[email protected]
619-532-7136
University of MontanaMissoulaMontana59812
Brian Loyd, PhD
[email protected]
406-243-4015
Andy Kittelson, PhD
[email protected]
406-243-4015

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By research site
Naval Medical Center San Diego· San Diego, CAUniversity of Montana· Missoula, MT

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