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

NCT03515967 | Withdrawn FDA Device

• 1 other identifier: 20170209
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Conditions

Brain Injuries, Traumatic

Keywords

concussion, mild traumatic brain injury

Outcome Measures

Primary Outcomes (1)

• Number of participants with mTBI

  How many participants were detected to have mTBI following a sports-related injury

  45 months

Secondary Outcomes (1)

• Time to recover

  45 months

Study Arms (2)

Injured Athletes

EXPERIMENTAL

Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles

Device: I-PAS Goggles

Non-Injured Athletes

ACTIVE COMPARATOR

Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles

Device: I-PAS Goggles

Interventions

I-PAS Goggles DEVICE

Portable, head-mounted display goggle system with integrated eye capture technology

Injured Athletes; Non-Injured Athletes

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Participants from 18-90 years of age who are or have been engaged in Olympic level competitions as an active participant or team member.
• 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.

You may not qualify if:

• History of brain injury resulting from a penetrating wound to the head.
• Presence of aphasia and/or inability to give informed consent for participation
• History of diagnosed neuropsychiatric disorders
• Documented neurodegenerative disorders
• Prior disorders of hearing and balance including:
• Meniere's disease
• Multiple sclerosis
• Vestibular neuritis
• Vestibular schwannoma
• 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.
• Presence of intra-cranial structural findings on imaging studies
• Prisoners

Sponsors & Collaborators

• University of Miami: lead
• Syneos Health: collaborator
• Neurolign: collaborator

Related Publications (2)

• 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.

  PMID: 28894835 BACKGROUND

• 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.

  PMID: 27654131 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Condition Hierarchy (Ancestors)

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

Study Officials

• Michael Hoffer, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 4, 2018
• Study Start: March 19, 2018
• Primary Completion: April 8, 2019
• Study Completion: April 8, 2019
• Last Updated: June 26, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share