Testing mTBI in Athletes

Mild Traumatic Brain Injury Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02486003
• Other study ID #: 20150361
• Status: Completed
• Phase: N/A
• First received: June 26, 2015
• Last updated: December 20, 2017
• Start date: May 2015
• Est. completion date: August 14, 2017

Study information

• Verified date: December 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: August 14, 2017
• Est. primary completion date: August 14, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Mild Traumatic Brain Injury

Locations

Country	Name	City	State
United States	University of Miami Miller School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Football League

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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