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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 (F

Brief 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 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 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.
Sponsor: Mosaic Life Care

Current Primary Outcome: MRI Brain SWI and FLAIR Lesions pre and post high school football season with and without the Guardian Cap [ Time Frame: within the first two months after the high school football season ends ]

MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • ImPact concussion scores pre and post high school football season with and without the Guardian Cap [ Time Frame: within the first two months after the high school football season ends ]
    Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap
  • Number of MRI Brain SWI and FLAIR lesions in preseason high school football players [ Time Frame: within two months of the start of high school football season ]
    Establish the expected range of MRI Brain SWI and FLAIR lesions in the general high school population at the beginning of a high school football season
  • Number of MRI Brain SWI and FLAIR lesions in postseason high school football players [ Time Frame: within two months of the end of high school football season ]
    Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players


Original Secondary Outcome: Same as current

Information By: Mosaic Life Care

Dates:
Date Received: April 27, 2016
Date Started: April 2016
Date Completion:
Last Updated: August 8, 2016
Last Verified: August 2016