Brain Injuries, Traumatic
Conditions
Keywords
concussion, mild traumatic brain injury
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
Interventions
DEVICEI-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology
Sponsors
Syneos Health
Neurolign
University of Miami
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with mTBI | 45 months | How many participants were detected to have mTBI following a sports-related injury |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to recover | 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 |
Outcome results
None listed