Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2026-02-28 @ 10:21 PM
Study NCT ID:
NCT01890304
Status:
TERMINATED
Last Update Posted:
2021-02-26
First Post:
2013-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Study of Traumatic Brain Injury (TBI) in (University of Florida) UF Athletes
Sponsor:
University of Florida
Organization:
Study Overview
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.
Status:
TERMINATED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Available MRI scan unable to collect required data elements.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GATOR TBI
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: