Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes

Not Applicable

Terminated

• Conditions: Traumatic Brain Injury
• Interventions: Other: Magnetic Resonance Imaging (MRI)

• Registration Number: NCT01890304
• Lead Sponsor: University of Florida

Brief Summary

To identify the changes in the brain following repeated sports-related concussion in men's football, women's soccer, and women's lacrosse college athletes by reviewing the findings of MRI studies that look at the structure of the brain and the appearance of the white matter at baseline, during the acute phase of a concussive injury, and upon completion of collegiate athletic play and correlate these findings with standard clinical measures.

Detailed Description

This proposal seeks to study Diffusion Tensor Imaging and functional MRI of the brain at 1) baseline, 2) after concussion and 3) at the end of an athlete's college career. Findings will be compared to standard clinical measures already performed in the management of concussion at the University of Florida Athletic Association and to serum biomarkers already being obtained as part of a UF/ Banyan Biomarker Study. As in the biomarker study, UF athletes on teams with higher incidences of sports related concussion; men's football, women's soccer, and women's lacrosse will be offered enrollment.

Longitudinal examinations will allow identification and quantification of concussive DTI findings as comparisons can be made to the individual athlete's baseline data. This will provide valuable correlation of imaging findings with severity of clinical symptoms at the time of injury and also with timing of return to play.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-06-26
• Study Start: 2013-07
• Study First Posted: 2013-07-01
• Primary Completion: 2018-06-20
• Study Completion: 2018-06-20
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-25
• Last Update Posted: 2021-02-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

• Currently enrolled and active UF student athlete in Mens Football, Womens Soccer, or Womens Lacrosse.
• Age 18-30

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Exclusion Criteria

• Contraindications to MRI, such as retained metal
• Pregnancy

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Magnetic Resonance Imaging (MRI)	Magnetic Resonance Imaging (MRI)	Athletes at risk for mild traumatic brain injury during the course of competitive play or practice. An MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.

Primary Outcome Measures

Name	Time	Method
Fractional Anisotropy (FA)	Change in baseline up to 5 years.	Changes in FA values will assessed in the white matter of the brain at the time points noted.

Secondary Outcome Measures

Name	Time	Method
Neuropsychometric testing	Change in baseline up to 5 years.	Correlation of standard neuropsychometric testing will be compared with results of MRI.

Trial Locations

Locations (1)

Shands Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States