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

NCT ID: NCT01890304

Last Updated: 2021-02-26

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 750 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-07-31
• Study Completion Date: 2018-06-20

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Magnetic Resonance Imaging (MRI)

Intervention Type: OTHER

MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.

Interventions

Magnetic Resonance Imaging (MRI)

MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keith R Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Associate Professor of Radiology

Locations

Shands Hospital at the University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

68-2013

Identifier Type: -

Identifier Source: org_study_id