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

• ClinicalTrials.gov Identifier: NCT03515967
• Recruitment Status: Withdrawn
• First Posted: May 4, 2018
• Last Update Posted: June 26, 2020
• Sponsor: University of Miami
• Collaborators: Syneos Health; Neurolign
• Information provided by (Responsible Party): Michael E. Hoffer, University of Miami

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Brain Injuries, Traumatic	Device: I-PAS Goggles	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: 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)
• Actual Study Start Date: March 19, 2018
• Actual Primary Completion Date: April 8, 2019
• Actual Study Completion Date: April 8, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Number of participants with mTBI [ Time Frame: 45 months ]
   How many participants were detected to have mTBI following a sports-related injury

Secondary Outcome Measures :

1. Time to recover [ Time Frame: 45 months ]
   Measuring the time (days) it takes for readiness to return to sports activity after sports-related injury for participants with a detected mTBI

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Sponsors and Collaborators

University of Miami

Syneos Health

Neurolign

Investigators

• Principal Investigator: Michael Hoffer, MD; University of Miami

More Information

Publications:

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.

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.

• Responsible Party: Michael E. Hoffer, Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT03515967
• Other Study ID Numbers: 20170209
• First Posted: May 4, 2018
• Last Update Posted: June 26, 2020
• Last Verified: June 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by Michael E. Hoffer, University of Miami:

concussion, mild traumatic brain injury

Additional relevant MeSH terms:

Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating