NCT02757053

Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury

Screening Brain MRI in High School Football: What is the Risk of Traumatic Brain Injury and Does the Guardian Cap Reduce the Incidence of Injury as Determined by Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) Magnetic Resonance Imaging (MRI) Sequences

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Mosaic Life Care · Academic / Other
• Sex: All
• Age: 12 Years – 20 Years
• Healthy volunteers: Accepted

Summary

Screening Brain magnetic resonance imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT scores and MRI findings between the two groups to see if there is a statistical difference in reduction of injury and to establish what the baseline level of MRI findings related to injury from high school football is as well as what the baseline level of injury is prior to the start of the season.

Detailed description

Screening Brain Magnetic Resonance Imaging (MRI) with Fluid-attenuated Inversion Recovery (FLAIR) and Susceptibility Weighted Imaging (SWI) sequences will be performed pre and post season on high school football players. One set of players will wear the Guardian Cap on their five star rated helmets and the other will wear five star rated helmets only. The investigators will compare outcomes of ImPACT concussion scores and MRI findings on FLAIR and SWI sequences between the two groups to see if there is a statistical difference in reduction of MRI findings on FLAIR and SWI sequences or adverse ImPACT concussion score outcomes and to establish what the baseline level of MRI findings on FLAIR and SWI sequences related to injury from high school football is as well as what the baseline level of MRI findings on FLAIR and SWI is prior to the start of the season.

Conditions

• Brain Concussion
• Brain Injuries
• Diffuse Axonal Injury
• Athletic Injuries
• Injury, Brain, Traumatic

Interventions

Type	Name	Description
DEVICE	Guardian Cap	The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-06-14
• Completion: 2016-06-14
• First posted: 2016-04-29
• Last updated: 2018-05-14
• Results posted: 2018-05-14

Locations

1 site across 1 country: United States