Testing mTBI in Athletes

University of Miami

Status

Completed

Conditions

Mild Traumatic Brain Injury

Brain Concussion

Study type

Observational

Funder types

Other

Identifiers

NCT02486003

20150361

Details and patient eligibility

About

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

Full 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.

Enrollment

329 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.