Evaluation of Mild TBI in Collegiate Athletes (AWARE)

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

Tracking Information

• First Submitted Date: July 9, 2014
• First Posted Date: July 14, 2014
• Last Update Posted Date: December 16, 2020
• Study Start Date: August 2014
• Actual Primary Completion Date: July 25, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 10, 2014): 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 ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: July 10, 2014)

• 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 ]
• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Mild TBI in Collegiate Athletes
• 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)
• 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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Traumatic Brain Injury
• Intervention: Not Provided

Study Groups/Cohorts

• Sports induced concussion
  Exposure to sports induced concussion
• Routine Athletic Exertion
  Exposure to routine athletic exertion without sports-induced concussion (non-concussion control)

Publications *

• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: July 10, 2014): 500
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: July 25, 2018
• Actual Primary Completion Date: July 25, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02189525
• Other Study ID Numbers: HHC-001
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Banyan Biomarkers, Inc
• Study Sponsor: Banyan Biomarkers, Inc
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Banyan Biomarkers, Inc
• Verification Date: December 2020