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

April 10, 2018 updated by: Paul Isenbarger, Mosaic Life Care

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Joseph, Missouri, United States, 64506
        • Mosaic Life Care

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Guardian Cap
The set of high school football players wearing the Guardian Cap on their helmets
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
Other Names:
  • Third party add-on
NO_INTERVENTION: No Guardian Cap
The set of high school football players not wearing the Guardian Cap on their helmets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
Time Frame: within the first two months after the high school football season ends
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap
Time Frame: within the first two months after the high school football season ends
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
Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players
Time Frame: within two months of the start of high school football season
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
Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players
Time Frame: within two months of the end of high school football season
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mosaic Life Care

Collaborators

Missouri Western State University

Investigators

  • Principal Investigator: Paul A Isenbarger, MD, Daignostic and Interventional Radiologist at Mosaic Life care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

June 14, 2016

Study Completion (ACTUAL)

June 14, 2016

Study Registration Dates

First Submitted

April 27, 2016

First Submitted That Met QC Criteria

April 28, 2016

First Posted (ESTIMATE)

April 29, 2016

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MLC002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to share data with MRI results of individual exams with the patient and plan to publish in peer reviewed journal

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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