Study Stopped
Available MRI scan unable to collect required data elements.
Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes
GATOR TBI
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.
1 other identifier
interventional
750
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2013
CompletedFirst Posted
Study publicly available on registry
July 1, 2013
CompletedStudy Start
First participant enrolled
July 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 20, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2018
CompletedFebruary 26, 2021
February 1, 2021
5 years
June 26, 2013
February 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Fractional Anisotropy (FA)
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 Outcomes (1)
Neuropsychometric testing
Change in baseline up to 5 years.
Study Arms (1)
Magnetic Resonance Imaging (MRI)
OTHERAthletes 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.
Interventions
MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.
Eligibility Criteria
You may qualify if:
- Currently enrolled and active UF student athlete in Mens Football, Womens Soccer, or Womens Lacrosse.
- Age 18-30
You may not qualify if:
- Contraindications to MRI, such as retained metal
- Pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shands Hospital at the University of Florida
Gainesville, Florida, 32610, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Keith R Peters, MD
Associate Professor of Radiology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2013
First Posted
July 1, 2013
Study Start
July 1, 2013
Primary Completion
June 20, 2018
Study Completion
June 20, 2018
Last Updated
February 26, 2021
Record last verified: 2021-02