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NCT02189525 Clinical Trial

Evaluation of Mild TBI in Collegiate Athletes

Traumatic Brain Injury Clinical Trial

— AWARE  

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)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02189525
Other study ID # HHC-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 2014
Est. completion date July 25, 2018

Study information
Verified date December 2020
Source Banyan Biomarkers, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date July 25, 2018
Est. primary completion date July 25, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Florida Gainesville Florida

Sponsors (1)
Lead Sponsor Collaborator
Banyan Biomarkers, Inc

Country where clinical trial is conducted

United States, 

References & Publications (3)

Asken BM, Bauer RM, DeKosky ST, Houck ZM, Moreno CC, Jaffee MS, Dubose DN, Boone JK, Weber AG, Clugston JR. Concussion BASICS II: Baseline serum biomarkers, head impact exposure, and clinical measures. Neurology. 2018 Dec 4;91(23):e2123-e2132. doi: 10.1212/WNL.0000000000006616. Epub 2018 Nov 7. — View Citation

Asken BM, Bauer RM, DeKosky ST, Houck ZM, Moreno CC, Jaffee MS, Weber AG, Clugston JR. Concussion Biomarkers Assessed in Collegiate Student-Athletes (BASICS) I: Normative study. Neurology. 2018 Dec 4;91(23):e2109-e2122. doi: 10.1212/WNL.0000000000006613. Epub 2018 Nov 7. — View Citation

Asken BM, Bauer RM, DeKosky ST, Svingos AM, Hromas G, Boone JK, DuBose DN, Hayes RL, Clugston JR. Concussion BASICS III: Serum biomarker changes following sport-related concussion. Neurology. 2018 Dec 4;91(23):e2133-e2143. doi: 10.1212/WNL.0000000000006617. Epub 2018 Nov 7. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion Baseline and up to 48 months
Secondary 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
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