Clinical trial NCT03515967: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Brain Injuries, Traumatic
Keywords: concussion, mild traumatic brain injury
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Syneos Health
name: Neurolign
First posted: 2018-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


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

Primary outcomes:
measure: Number of participants with mTBI
timeFrame: 45 months
Secondary outcomes:
measure: Time to recover
timeFrame: 45 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Michael Hoffer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.