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

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ClinicalTrials.gov Identifier: NCT03515967
Recruitment Status : Withdrawn (Study closed.)
First Posted : May 4, 2018
Last Update Posted : April 15, 2019
Sponsor:
Collaborators:
Syneos Health
Neuro Kinetics
Information provided by (Responsible Party):
Michael E. Hoffer, 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

Condition or disease Intervention/treatment Phase
Brain Injuries, Traumatic Device: I-PAS Goggles Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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)
Actual Study Start Date : March 19, 2018
Actual Primary Completion Date : April 8, 2019
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Injured Athletes
Athletes tested for mild traumatic brain injury (mTBI) after injury using the I-PAS goggles
Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology

Active Comparator: Non-Injured Athletes
Athletes tested for mild traumatic brain injury (mTBI) with no injury using the I-PAS goggles
Device: I-PAS Goggles
Portable, head-mounted display goggle system with integrated eye capture technology




Primary Outcome Measures :
  1. Number of participants with mTBI [ Time Frame: 45 months ]
    How many participants were detected to have mTBI following a sports-related injury


Secondary Outcome Measures :
  1. Time to recover [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515967


Locations
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United States, Florida
Hecht Athletic Center
Miami, Florida, United States, 33146
Sponsors and Collaborators
University of Miami
Syneos Health
Neuro Kinetics
Investigators
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Principal Investigator: Michael Hoffer, MD University of Miami

Publications:
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Responsible Party: Michael E. Hoffer, Professor, University of Miami
ClinicalTrials.gov Identifier: NCT03515967     History of Changes
Other Study ID Numbers: 20170209
First Posted: May 4, 2018    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Michael E. Hoffer, University of Miami:
concussion, mild traumatic brain injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating