Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups

The Use of a Portable 3D Head Mounted Display With Integrated Eye Capture Technology (I-PAS) for the Objectification and Quantification of Signs and Symptoms Associated With the Diagnosis of Mild Traumatic Brain Injury (mTBI)

Study will test the use of a short virtual reality driven goggle test as a means of detecting mTBI in a diverse group of athletes

Study Overview

• Status: Withdrawn
• Conditions: Brain Injuries, Traumatic
• Intervention / Treatment: Device: I-PAS Goggles

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Participants from 18 - 90 years of age who participate in all amateur athletics at the University of Miami to include all levels of sports whether National Collegiate Athletic Association (NCAA) or Club. Initial recruitment will include high intensity sports, including but not limited to Men's football, Men's and Women's Soccer, Men's and Women's Basketball, Men's and Women's Volleyball, Men's Baseball and Women's Softball, and Club sports to include Men's and Women's Lacrosse, Hockey, Rugby, and Field Hockey).
2. Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
3. Participants from 18-90 years of age who are engaged in professional sports as an active participant or formerly as a team member. Initial recruitment will include all motor sports, ice and field hockey, football, soccer, basketball, and rugby.

Exclusion Criteria:

1. History of brain injury resulting from a penetrating wound to the head.
2. Presence of aphasia and/or inability to give informed consent for participation
3. History of diagnosed neuropsychiatric disorders
4. Documented neurodegenerative disorders

5. 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
6. Cerebrovascular disorders
7. History of ear operation other than myringotomy tube in the past
8. Systemic disorders: e.g. chronic renal failure, cirrhosis of the liver, etc.
9. Presence of intra-cranial structural findings on imaging studies
10. Prisoners

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injured Athletes; Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles	Device: I-PAS Goggles; Portable, head-mounted display goggle system with integrated eye capture technology
Active Comparator: Non-Injured Athletes; Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles	Device: I-PAS Goggles; Portable, head-mounted display goggle system with integrated eye capture technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with mTBI	How many participants were detected to have mTBI following a sports-related injury	45 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to recover	Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI	45 months

Collaborators and Investigators

• Sponsor: University of Miami
• Collaborators: Syneos Health; Neurolign

Publications and helpful links

General Publications

• Balaban C, Hoffer ME, Szczupak M, Snapp H, Crawford J, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. Oculomotor, Vestibular, and Reaction Time Tests in Mild Traumatic Brain Injury. PLoS One. 2016 Sep 21;11(9):e0162168. doi: 10.1371/journal.pone.0162168. eCollection 2016.
• Hoffer ME, Balaban C, Szczupak M, Buskirk J, Snapp H, Crawford J, Wise S, Murphy S, Marshall K, Pelusso C, Knowles S, Kiderman A. The use of oculomotor, vestibular, and reaction time tests to assess mild traumatic brain injury (mTBI) over time. Laryngoscope Investig Otolaryngol. 2017 Apr 12;2(4):157-165. doi: 10.1002/lio2.74. eCollection 2017 Aug.

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2018
• Primary Completion (Actual): April 8, 2019
• Study Completion (Actual): April 8, 2019

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: April 23, 2018
• First Posted (Actual): May 4, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: concussion, mild traumatic brain injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 20170209

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No