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

Mosaic Life Care

Status: Terminated

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

Treatments: Device: Guardian Cap

Study type: Interventional

Funder types: Other

Identifiers

NCT02757053

MLC002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Guardian Cap

Experimental group

Description:

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

Treatment:

Device: Guardian Cap

No Guardian Cap

No Intervention group

Description:

The set of high school football players not wearing the Guardian Cap on their helmets