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

University of Miami logo

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Withdrawn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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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