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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Guardian Cap


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High school football players willing and able to have a pre and post season Brain MRI with FLAIR and SWI sequences and wear the Guardian Cap on their helmet Exclusion Criteria: High school football players unwilling or unable to have an MRI

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Guardian Cap<br>The set of high school football players wearing the Guardian Cap on their helmets | Device: Guardian Cap<br>* 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<br>* Other names: Third party add-on;|
| No Intervention: No Guardian Cap<br>The set of high school football players not wearing the Guardian Cap on their helmets | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap | MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap | within the first two months after the high school football season ends | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap | Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap | within the first two months after the high school football season ends | 
| Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players | 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 | within two months of the start of high school football season | 
| Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players | Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players | within two months of the end of high school football season | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Football, Head Protective Devices, Magnetic Resonance Imaging, Helmet, Third party add-on