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

Sponsor
University of Florida (Other)
Overall Status
Terminated
CT.gov ID
NCT01890304
Collaborator
(none)
750
1
1
59.6
12.6

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Magnetic Resonance Imaging (MRI)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
750 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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.
Actual Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Jun 20, 2018
Actual Study Completion Date :
Jun 20, 2018

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Neuropsychometric testing [Change in baseline up to 5 years.]

    Correlation of standard neuropsychometric testing will be compared with results of MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shands Hospital at the University of Florida Gainesville Florida United States 32610

Sponsors and Collaborators

  • University of Florida

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Florida
ClinicalTrials.gov Identifier:
NCT01890304
Other Study ID Numbers:
  • 68-2013
First Posted:
Jul 1, 2013
Last Update Posted:
Feb 26, 2021
Last Verified:
Feb 1, 2021
Keywords provided by University of Florida
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 26, 2021