Testing mTBI in Athletes

Study Overview
=================
Brief Summary
-----------------
This study will assess the effectiveness of a portable goggle system in the diagnosis of mild traumatic brain injury (mTBI) in athletes.

Detailed Description
-----------------
The purpose of this research study is to assess oculomotor, vestibular and reaction time responses in mild traumatic brain injury (mTBI) athletes, as well as healthy individuals. These measurements will be recorded using a portable goggle system (IPAS). The goal is to determine whether this IPAS goggle system is effective at diagnosing mTBI. A secondary goal is to determine whether this IPAS goggle system is effective at ruling out the diagnosis of mTBI in athletes and non-athletes that do not have the condition. The IPAS is a portable 3D head mounted display. The IPAS goggles are programmed with a series of tests that track eye motions in response to a target. This device has been determined to be a Non-Significant Risk to study participants. There are three groups of interest in this study: athletes who suffer an mTBI, athletes who do have an mTBI, and healthy non-athletes.

Official Title
-----------------
The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology for the Diagnosis of Dizziness Associated With Mild Traumatic Brain Injury (mTBI)

Conditions
-----------------
Mild Traumatic Brain Injury, Brain Concussion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females from 18 - 40 years of age who participate in intercollegiate athletics at the University of Miami to include all levels of sports whether NCAA or club. Initial recruitment will include high intensity sports alone (these include but are not limited to football, Men's and Women's Soccer, Men's and Women's Basketball, Men's Baseball and Women's Softball, and club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey). Exclusion Criteria: History of brain injury resulting from a penetrating wound to the head. Presence of severe aphasia History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia Documented neurodegenerative disorders Pregnancy, [Female candidates will be asked if they are pregnant] 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| mTBI athletes<br>College athletes who undergo an mTBI during the season | |
| Control athletes<br>College athletes who do not undergo an mTBI during the season | |
| Control non-athletes<br>Control non-athletes with long term follow-up of approximately 4-6 weeks and 3-5 months | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vestibular, oculomotor, and reaction time test results | IPAS testing will be conducted by placing the IPAS goggles on the head of a patient and asking the patient to follow instructions while a set of tests is performed. Each of these tests simply involves eye motions in response to a target. | 3 months |