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Completed

NCT Number: NCT02486003

Testing mTBI in Athletes

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Vestibular, oculomotor, and reaction time test results

    Time frame: 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • National Football League

Registry information

Official study 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)

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jun 30, 2015
Registry last updated
Dec 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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