Evaluation of Mild TBI in Collegiate Athletes
Completed
- Conditions
- Traumatic Brain Injury
- Registration Number
- NCT02189525
- Lead Sponsor
- Banyan Biomarkers, Inc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 500
Inclusion Criteria
- 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.
- Age greater than or equal to 18 years of age.
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussion Baseline and up to 48 months
- Secondary Outcome Measures
Name Time Method 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 Baseline and up to 48 months Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion Baseline and up to 48 months
Trial Locations
- Locations (1)
University of Florida
🇺🇸Gainesville, Florida, United States