Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups

Study Overview
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Brief Summary
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Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes

Official Title
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The Use of a Portable 3D Head Mounted Display With Integrated Eye Capture Technology (I-PAS) for the Objectification and Quantification of Signs and Symptoms Associated With the Diagnosis of Mild Traumatic Brain Injury (mTBI)

Conditions
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Brain Injuries, Traumatic

Intervention / Treatment
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* Device: I-PAS Goggles


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey). Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby. Exclusion Criteria: History of brain injury resulting from a penetrating wound to the head. Presence of aphasia and/or inability to give informed consent for participation History of diagnosed neuropsychiatric disorders Documented neurodegenerative disorders Prior disorders of hearing and balance including: Meniere's disease Multiple sclerosis Vestibular neuritis Vestibular schwannoma Sudden sensorineural hearing loss Cerebrovascular disorders History of ear operation other than myringotomy tube in the past Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc. Presence of intra-cranial structural findings on imaging studies Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injured Athletes<br>Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles | Device: I-PAS Goggles<br>* Portable, head-mounted display goggle system with integrated eye capture technology<br>|
| Active Comparator: Non-Injured Athletes<br>Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles | Device: I-PAS Goggles<br>* Portable, head-mounted display goggle system with integrated eye capture technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with mTBI | How many participants were detected to have mTBI following a sports-related injury | 45 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to recover | Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI | 45 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, mild traumatic brain injury