Back to resultsLongitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes (GATOR TBI)
Primary Purpose
Traumatic Brain Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Magnetic Resonance Imaging (MRI)
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury focused on measuring Traumatic Brain Injury, TBI, Concussion, Sports related injury
Eligibility Criteria
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
Sites / Locations
- Shands Hospital at the University of Florida
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Magnetic Resonance Imaging (MRI)
Arm Description
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.
Outcomes
Primary Outcome Measures
Fractional Anisotropy (FA)
Changes in FA values will assessed in the white matter of the brain at the time points noted.
Secondary Outcome Measures
Neuropsychometric testing
Correlation of standard neuropsychometric testing will be compared with results of MRI.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01890304
Brief Title
Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes
Acronym
GATOR TBI
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Available MRI scan unable to collect required data elements.
Study Start Date
July 2013 (Actual)
Primary Completion Date
June 20, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
Keywords
Traumatic Brain Injury, TBI, Concussion, Sports related injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
750 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Magnetic Resonance Imaging (MRI)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.
Primary Outcome Measure Information:
Title
Fractional Anisotropy (FA)
Description
Changes in FA values will assessed in the white matter of the brain at the time points noted.
Time Frame
Change in baseline up to 5 years.
Secondary Outcome Measure Information:
Title
Neuropsychometric testing
Description
Correlation of standard neuropsychometric testing will be compared with results of MRI.
Time Frame
Change in baseline up to 5 years.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keith R Peters, MD
Organizational Affiliation
Associate Professor of Radiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes
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