Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury
Primary Purpose
Brain Concussion, Brain Injuries, Diffuse Axonal Injury
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Guardian Cap
Sponsored by
About this trial
This is an interventional prevention trial for Brain Concussion focused on measuring Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Football, Head Protective Devices, Magnetic Resonance Imaging, Helmet, Third party add-on
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
Sites / Locations
- Mosaic Life Care
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Guardian Cap
No Guardian Cap
Arm Description
The set of high school football players wearing the Guardian Cap on their helmets
The set of high school football players not wearing the Guardian Cap on their helmets
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
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
Full Information
NCT ID
NCT02757053
First Posted
April 27, 2016
Last Updated
April 10, 2018
Sponsor
Mosaic Life Care
Collaborators
Missouri Western State University
1. Study Identification
Unique Protocol Identification Number
NCT02757053
Brief Title
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
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Terminated
Why Stopped
This study was terminated June 28 2016 for low enrollment and PI moving away. No results were obtained
Study Start Date
April 2016 (undefined)
Primary Completion Date
June 14, 2016 (Actual)
Study Completion Date
June 14, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mosaic Life Care
Collaborators
Missouri Western State University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Guardian Cap
Arm Type
Experimental
Arm Description
The set of high school football players wearing the Guardian Cap on their helmets
Arm Title
No Guardian Cap
Arm Type
No Intervention
Arm Description
The set of high school football players not wearing the Guardian Cap on their helmets
Intervention Type
Device
Intervention Name(s)
Guardian Cap
Other Intervention Name(s)
Third party add-on
Intervention Description
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
Primary Outcome Measure Information:
Title
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
Description
MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap
Time Frame
within the first two months after the high school football season ends
Secondary Outcome Measure Information:
Title
ImPact Concussion Scores Pre and Post High School Football Season With and Without the Guardian Cap
Description
Establish the expected range of ImPact concussion scores pre and post football season with and without the Guardian Cap
Time Frame
within the first two months after the high school football season ends
Title
Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players
Description
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
Time Frame
within two months of the start of high school football season
Title
Number of MRI Brain SWI and FLAIR Lesions in Postseason High School Football Players
Description
Establish the incidence 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Isenbarger, MD
Organizational Affiliation
Daignostic and Interventional Radiologist at Mosaic Life care
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mosaic Life Care
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Plan to share data with MRI results of individual exams with the patient and plan to publish in peer reviewed journal
Citations:
PubMed Identifier
23062584
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.
Results Reference
background
PubMed Identifier
7985582
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.
Results Reference
background
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Screening Brain MRI in High School Football: Does the Guardian Cap Reduce the Risk of Traumatic Brain Injury
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