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

University of Miami

Status: Withdrawn

Conditions: Brain Injuries, Traumatic

Treatments: Device: I-PAS Goggles

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03515967

20170209

Details and patient eligibility

About

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

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Injured Athletes

Experimental group

Description:

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

Treatment:

Device: I-PAS Goggles

Non-Injured Athletes

Active Comparator group

Description:

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

Treatment:

Device: I-PAS Goggles