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• Recruitment Status: Withdrawn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: April 15, 2019
• Sponsor: University of Miami
• Collaborators: Syneos Health; Neuro Kinetics
• Information provided by (Responsible Party): Michael E. Hoffer, University of Miami

Tracking Information

• First Submitted Date: April 23, 2018
• First Posted Date: May 4, 2018
• Last Update Posted Date: April 15, 2019
• Actual Study Start Date: March 19, 2018
• Actual Primary Completion Date: April 8, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2018)

Number of participants with mTBI [ Time Frame: 45 months ]

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

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03515967 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: April 23, 2018)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Testing Mild Traumatic Brain Injury (mTBI) in Diverse Athletic Groups
• 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)
• 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
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Brain Injuries, Traumatic

Intervention

Device: I-PAS Goggles

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

Study Arms

• Experimental: Injured Athletes
  Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles
  Intervention: Device: I-PAS Goggles
• Active Comparator: Non-Injured Athletes
  Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles
  Intervention: Device: I-PAS Goggles

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.

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: April 11, 2019): 0
• Original Estimated Enrollment (submitted: April 23, 2018): 1000
• Actual Study Completion Date: April 8, 2019
• Actual Primary Completion Date: April 8, 2019 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 90 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03515967
• Other Study ID Numbers: 20170209
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: No
• Pediatric Postmarket Surveillance of a Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Michael E. Hoffer, University of Miami
• Study Sponsor: University of Miami

Collaborators

• Syneos Health
• Neuro Kinetics

Investigators

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

• PRS Account: University of Miami
• Verification Date: April 2019