Athletic Injuries, Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Injury, Brain, Traumatic
Conditions
Keywords
Brain Concussion, Brain Injuries, Diffuse Axonal Injury, Football, Head Protective Devices, Magnetic Resonance Imaging, Helmet, Third party add-on
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.
Interventions
DEVICEGuardian 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
Sponsors
Missouri Western State University
Mosaic Life Care
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 20 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI Brain SWI and FLAIR Lesions 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 | MRI Brain SWI Lesions pre and post football season with and without the Guardian Cap |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 | 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 |
| 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 | Establish the incidence of MRI Brain SWI and FLAIR lesions in postseason high school football players |
Countries
United States
Participant flow
Pre-assignment details
Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination.
Participants by arm
| Arm | Count |
|---|---|
| Guardian Cap The set of high school football players wearing the Guardian Cap on their helmets
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 | 3 |
| No Guardian Cap The set of high school football players not wearing the Guardian Cap on their helmets | 5 |
| Total | 8 |
Baseline characteristics
| Characteristic | Guardian Cap | No Guardian Cap | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 3 Participants | 5 Participants | 8 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 3 participants | 5 participants | 8 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 3 Participants | 5 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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
Time frame: within the first two months after the high school football season ends
Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.
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
Time frame: within the first two months after the high school football season ends
Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.
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
Time frame: within two months of the end of high school football season
Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.
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
Time frame: within two months of the start of high school football season
Population: Study was prematurely terminated due to the PI leaving the area. A few participants did enroll with baseline data only being collected prior to termination. No outcome data collected.