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Evaluation of Mild TBI in Collegiate Athletes (AWARE)

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ClinicalTrials.gov Identifier: NCT02189525
Recruitment Status : Completed
First Posted : July 14, 2014
Last Update Posted : December 16, 2020
Sponsor:
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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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