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

NCT02757053 | Terminated Results DMC

• 1 other identifier: MLC002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

Guardian Cap

EXPERIMENTAL

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

Device: Guardian Cap

No Guardian Cap

NO INTERVENTION

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

Interventions

Guardian Cap DEVICE

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

Also known as: Third party add-on

Guardian Cap

Eligibility Criteria

• Age: 12 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• High school football players unwilling or unable to have an MRI

Sponsors & Collaborators

• Mosaic Life Care: lead
• Missouri Western State University: collaborator

Study Sites (1)

Mosaic Life Care

Saint Joseph, Missouri, 64506, United States

Location

Related 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.

  PMID: 23062584 BACKGROUND

• 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.

  PMID: 7985582 BACKGROUND

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Brain Injuries, Diffuse

Results Point of Contact

• Title: Clinical Research Development Manager
• Organization: Heartland Regional Medical Center dba Mosaic Life Care

Linda.Schumacher@mymlc.com

816 271 7937

Study Officials

• Paul A Isenbarger, MD

  Daignostic and Interventional Radiologist at Mosaic Life care

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Diagnostic and Interventional Radiologist

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: April 29, 2016
• Study Start: April 1, 2016
• Primary Completion: June 14, 2016
• Study Completion: June 14, 2016
• Last Updated: May 14, 2018
• Results First Posted: May 14, 2018

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will share

Locations

US (1)