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

Not Applicable

Terminated

• Conditions: Brain Concussion; Brain Injuries; Athletic Injuries; Injury, Brain, Traumatic; Diffuse Axonal Injury
• Interventions: Device: Guardian Cap

• Registration Number: NCT02757053
• Lead Sponsor: Mosaic Life Care

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 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-27
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Primary Completion: 2016-06-14
• Study Completion: 2016-06-14
• Status Verified: 2016-08
• Results First Submitted: 2018-04-10
• Results First Submitted QC: 2018-04-10
• Last Update Submitted: 2018-04-10
• Results First Posted: 2018-05-14
• Last Update Posted: 2018-05-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guardian Cap	Guardian Cap	The set of high school football players wearing the Guardian Cap on their helmets

Primary Outcome Measures

Name	Time	Method
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap	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

Secondary Outcome Measures

Name	Time	Method
Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players	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
ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap	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	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

Trial Locations

Locations (1)

Mosaic Life Care; 🇺🇸 Saint Joseph, Missouri, United States