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

February 25, 2021 updated by: University of Florida

Diffusion Tensor Imaging (DTI) Compared to Serum Biomarkers and Standard Clinical Measures of Concussion in Female and Male Collegiate Athletes: a Longitudinal Survey Across the College Years.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

750

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Shands Hospital at the University of Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Contraindications to MRI, such as retained metal
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: Magnetic Resonance Imaging (MRI)
MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional Anisotropy (FA)
Time Frame: 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.
Change in baseline up to 5 years.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropsychometric testing
Time Frame: Change in baseline up to 5 years.
Correlation of standard neuropsychometric testing will be compared with results of MRI.
Change in baseline up to 5 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Keith R Peters, MD, Associate Professor of Radiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2013

Primary Completion (Actual)

June 20, 2018

Study Completion (Actual)

June 20, 2018

Study Registration Dates

First Submitted

June 26, 2013

First Submitted That Met QC Criteria

June 26, 2013

First Posted (Estimate)

July 1, 2013

Study Record Updates

Last Update Posted (Actual)

February 26, 2021

Last Update Submitted That Met QC Criteria

February 25, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 68-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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