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Evaluation of Mild TBI in Collegiate Athletes

AWARE: Mild Traumatic Brain Injury in Collegiate Athletes - A Prospective Study With Blood-based Biomarkers, Advanced Neuroimaging and the Head Impact Telemetry System (HITS)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02189525
Acronym
AWARE
Enrollment
500
Registered
2014-07-14
Start date
2014-08-31
Completion date
2018-07-25
Last updated
2020-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury, sports head injury, sports concussion

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.

Interventions

None listed

Sponsors

Banyan Biomarkers, Inc
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Correlation of serum biomarker levels with neuroanatomic and neuropathologic changes from baseline using neuroimaging, following sports-related concussionBaseline and up to 48 months

Secondary

MeasureTime frame
Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussionBaseline and up to 48 months
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 participationBaseline and up to 48 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026