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

Not Applicable

Withdrawn

• Conditions: Brain Injuries, Traumatic
• Interventions: Device: I-PAS Goggles

• Registration Number: NCT03515967
• Lead Sponsor: University of Miami

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2018-03-19
• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-04-23
• Study First Posted: 2018-05-04
• Primary Completion: 2019-04-08
• Study Completion: 2019-04-08
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-Injured Athletes	I-PAS Goggles	Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles
Injured Athletes	I-PAS Goggles	Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles

Primary Outcome Measures

Name	Time	Method
Number of participants with mTBI	45 months	How many participants were detected to have mTBI following a sports-related injury

Secondary Outcome Measures

Name	Time	Method
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