Testing mTBI in Athletes

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.

Study Overview

• Status: Completed
• Conditions: Brain Concussion; Mild Traumatic Brain Injury

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.

• Study Type: Observational
• Enrollment (Actual): 329

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University of Miami Miller School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the population of athletes in the intercollege athletic programs at the University of Miami. This will include athletes in NCAA Sports as well as intercollege club sports. Aged and sex matched controls will be collected from the general student body of the University of Miami.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
mTBI athletes; College athletes who undergo an mTBI during the season
Control athletes; College athletes who do not undergo an mTBI during the season
Control non-athletes; 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

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: National Football League

Study record dates

Study Major Dates

• Study Start: May 1, 2015
• Primary Completion (Actual): August 14, 2017
• Study Completion (Actual): August 14, 2017

Study Registration Dates

• First Submitted: June 26, 2015
• First Submitted That Met QC Criteria: June 26, 2015
• First Posted (Estimate): June 30, 2015

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 20150361