Clinical trial NCT02757053: Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury
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 (FLAIR) and Susceptibility Weighted Imaging (SWI) Magnetic Resonance Imaging (MRI) Sequences
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Brain Concussion
Brain Injuries
Diffuse Axonal Injury
Athletic Injuries
Injury, Brain, Traumatic
Keywords: Brain Concussion
Brain Injuries
Diffuse Axonal Injury
Football
Head Protective Devices
Magnetic Resonance Imaging
Helmet
Third party add-on
Lead sponsor: Mosaic Life Care
Sponsor class: OTHER
Collaborators: name: Missouri Western State University
First posted: 2016-04-29
Enrollment: 8
Sex: ALL
Minimum age (years): 12
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
timeFrame: within the first two months after the high school football season ends
Secondary outcomes:
measure: ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap
timeFrame: within the first two months after the high school football season ends
measure: Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players
timeFrame: within two months of the start of high school football season
measure: Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players
timeFrame: within two months of the end of high school football season
Other outcomes:
Locations:
city: Saint Joseph
country: United States
facility: Mosaic Life Care
state: Missouri
Study officials:
affiliation: Daignostic and Interventional Radiologist at Mosaic Life care
name: Paul A Isenbarger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Beauchamp MH, Beare R, Ditchfield M, Coleman L, Babl FE, Kean M, Crossley L, Catroppa C, Yeates KO, Anderson V. Susceptibility weighted imaging and its relationship to outcome after pediatric traumatic brain injury. Cortex. 2013 Feb;49(2):591-8. doi: 10.1016/j.cortex.2012.08.015. Epub 2012 Sep 3.
citation: Mittl RL, Grossman RI, Hiehle JF, Hurst RW, Kauder DR, Gennarelli TA, Alburger GW. Prevalence of MR evidence of diffuse axonal injury in patients with mild head injury and normal head CT findings. AJNR Am J Neuroradiol. 1994 Sep;15(8):1583-9.