Evaluation of Mild TBI in Collegiate Athletes

NCT02189525 | Completed

• 1 other identifier: HHC-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

traumatic brain injury; sports head injury; sports concussion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation of serum biomarker levels with head acceleration data using head impact telemetry system following sports-related concussion

  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

  Baseline and up to 48 months

Study Arms (2)

Sports induced concussion

Exposure to sports induced concussion

Routine Athletic Exertion

Exposure to routine athletic exertion without sports-induced concussion (non-concussion control)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• Subject is otherwise determined by the Investigator to be medically unsuitable for participation in the study

Sponsors & Collaborators

• Banyan Biomarkers, Inc: lead

Study Sites (1)

University of Florida

Gainesville, Florida, 32610, United States

Location

Related Publications (3)

• 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.

  PMID: 30404785 BACKGROUND

• 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.

  PMID: 30404782 BACKGROUND

• 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.

  PMID: 30404786 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2014
• First Posted: July 14, 2014
• Study Start: August 1, 2014
• Primary Completion: July 25, 2018
• Study Completion: July 25, 2018
• Last Updated: December 16, 2020

Record last verified: 2020-12

Locations

US (1)