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

Brain Injuries Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02757053
• Other study ID #: MLC002
• Status: Terminated
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 14, 2016

Study information

• Verified date: August 2016
• Source: Mosaic Life Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 14, 2016
• Est. primary completion date: June 14, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Diffuse Axonal Injury
• Injury, Brain, Traumatic
• Wounds and Injuries

Intervention

Device:
• Guardian Cap
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

Locations

Country	Name	City	State
United States	Mosaic Life Care	Saint Joseph	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Mosaic Life Care	Missouri Western State University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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