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

Traumatic Brain Injury Clinical Trial

— 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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01890304
• Other study ID #: 68-2013
• Status: Terminated
• Phase: N/A
• Start date: July 2013
• Est. completion date: June 20, 2018

Study information

• Verified date: February 2021
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 750
• Est. completion date: June 20, 2018
• Est. primary completion date: June 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Shands Hospital at the University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neuropsychometric testing	Correlation of standard neuropsychometric testing will be compared with results of MRI.	Change in baseline up to 5 years.