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OpenTrials
Completed

NCT Number: NCT02189525

Evaluation of Mild TBI in Collegiate Athletes

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

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Key information

Conditions

Traumatic Brain Injury Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Craniocerebral Trauma Nervous System Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Florida

Gainesville, Florida, 32610, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Banyan Biomarkers, Inc

Industry

Registry information

Official study 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)

Acronym: AWARE

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2014
Registry last updated
Dec 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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