Clinical Trial: Testing mTBI in Athletes

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official 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

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 Summary:

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.


Sponsor: University of Miami

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Miami

Dates:
Date Received: June 26, 2015
Date Started: May 2015
Date Completion: January 2019
Last Updated: December 22, 2016
Last Verified: December 2016