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

M

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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