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Evaluation of Mild TBI in Collegiate Athletes (AWARE)

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ClinicalTrials.gov Identifier: NCT02189525
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : December 16, 2020
Sponsor:
Information provided by (Responsible Party):
Banyan Biomarkers, Inc

Study Description
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Brief Summary:
The purpose of this study is to evaluate blood-based biomarkers before and after sports-induced concussion using neuroimaging and head impact sensor technology.

Condition or disease
Traumatic Brain Injury

Study Design
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Study Type : Observational
Actual Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: AWARE: Mild Traumatic Brain Injury in Collegiate Athletes - A Prospective Study With Blood-based Biomarkers, Advanced Neuroimaging and the Head Impact Telemetry System (HITS)
Study Start Date : August 2014
Actual Primary Completion Date : July 25, 2018
Actual Study Completion Date : July 25, 2018

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Groups and Cohorts
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Group/Cohort
Sports induced concussion
Exposure to sports induced concussion
Routine Athletic Exertion
Exposure to routine athletic exertion without sports-induced concussion (non-concussion control)


Outcome Measures
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Primary Outcome Measures :
  1. Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussion [ Time Frame: Baseline and up to 48 months ]

Secondary Outcome Measures :
  1. Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion [ Time Frame: Baseline and up to 48 months ]
  2. Correlation of serum biomarker levels and neuroimaging results to standard clinical measures of concussion in the acute phase of injury and at the completion of collegiate athletic participation [ Time Frame: Baseline and up to 48 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Collegiate atheltes from University of Florida involved in Men's Football, Women's Soccer, or Women's Lacrosse
Criteria

Inclusion Criteria:

  1. University of Florida student athlete involved in Men's Football, Men and Women's Basketball, Men and Women's Swimming, Men and Women's Diving, Women's Soccer, or Women's Lacrosse or University of Florida student athlete not participating in those sports who is being treated for a sports-related head injury.
  2. Age greater than or equal to 18 years of age.
  3. Willing to undergo the Informed Consent Process and provide Informed Consent prior to enrollment into the study.

Exclusion Criteria:

  • Subject is otherwise determined by the Investigator to be medically unsuitable for participation in the study
Contacts and Locations
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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): NCT02189525


Locations
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United States, Florida
University of Florida
Gainesville, Florida, United States, 32610
Sponsors and Collaborators
Banyan Biomarkers, Inc
More Information
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Publications:

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Responsible Party: Banyan Biomarkers, Inc
ClinicalTrials.gov Identifier: NCT02189525    
Other Study ID Numbers: HHC-001
First Posted: July 14, 2014    Key Record Dates
Last Update Posted: December 16, 2020
Last Verified: December 2020
Keywords provided by Banyan Biomarkers, Inc:
traumatic brain injury
sports head injury
sports concussion
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System