Testing mTBI in Athletes

Completed

• Conditions: Mild Traumatic Brain Injury; Brain Concussion

• Registration Number: NCT02486003
• Lead Sponsor: University of Miami

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-05
• Study First Submitted: 2015-06-26
• Study First Submitted QC: 2015-06-26
• Study First Posted: 2015-06-30
• Primary Completion: 2017-08-14
• Study Completion: 2017-08-14
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-20
• Last Update Posted: 2017-12-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vestibular, oculomotor, and reaction time test results	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.

Trial Locations

Locations (1)

University of Miami Miller School of Medicine; 🇺🇸 Miami, Florida, United States