Evaluation of Mild TBI in Collegiate Athletes (AWARE)

December 11, 2020 updated by: Banyan Biomarkers, Inc

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

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline and up to 48 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Baseline and up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Banyan Biomarkers, Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Actual)

July 25, 2018

Study Completion (Actual)

July 25, 2018

Study Registration Dates

First Submitted

July 9, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

Study Record Updates

Last Update Posted (Actual)

December 16, 2020

Last Update Submitted That Met QC Criteria

December 11, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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