Testing mTBI in Athletes



Status:Completed
Conditions:Neurology, Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 40
Updated:12/24/2017
Start Date:May 2015
End Date:August 14, 2017

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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)

This study will assess the effectiveness of a portable goggle system in the diagnosis of mild
traumatic brain injury (mTBI) in athletes.

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.

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:

1. Meniere's disease

2. Multiple sclerosis

3. Vestibular neuritis

4. Vestibular schwannoma

5. 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.
We found this trial at
1
site
1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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