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Evaluation of Mild TBI in Collegiate Athletes

NCT ID: NCT02189525

Last Updated: 2020-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-08-31

Study Completion Date

2018-07-25

Brief Summary

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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

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Conditions

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Traumatic Brain Injury

Keywords

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traumatic brain injury sports head injury sports concussion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sports induced concussion

Exposure to sports induced concussion

No interventions assigned to this group

Routine Athletic Exertion

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Banyan Biomarkers, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of Florida

Gainesville, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 30404785 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30404782 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30404786 (View on PubMed)

Other Identifiers

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HHC-001

Identifier Type: -

Identifier Source: org_study_id