Not provided
Not provided
Not provided
Not provided
Not provided
This study was terminated June 28 2016 for low enrollment and PI moving away. No results were obtained
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Missouri Western State University | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Guardian Cap | Experimental | The set of high school football players wearing the Guardian Cap on their helmets |
|
| No Guardian Cap | No Intervention | The set of high school football players not wearing the Guardian Cap on their helmets |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Number of MRI Brain SWI and FLAIR Lesions in Preseason High School Football Players |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Paul A Isenbarger, MD | Daignostic and Interventional Radiologist at Mosaic Life care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mosaic Life Care | Saint Joseph | Missouri | 64506 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23062584 | Background | 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. | |
| 7985582 | Background |
Not provided
Not provided
Plan to share data with MRI results of individual exams with the patient and plan to publish in peer reviewed journal
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | No Guardian Cap | The set of high school football players not wearing the Guardian Cap on their helmets |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | 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. | Posted | within the first two months after the high school football season ends |
|
Not provided
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 adverse event information collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Development Manager | Heartland Regional Medical Center dba Mosaic Life Care | 816 271 7937 | Linda.Schumacher@mymlc.com |
Not provided
| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| D020833 | Diffuse Axonal Injury |
| D001265 | Athletic Injuries |
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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 | 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 |
| 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. |
| BG001 |
| No Guardian Cap |
The set of high school football players not wearing the Guardian Cap on their helmets |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 |
| No Guardian Cap |
The set of high school football players not wearing the Guardian Cap on their helmets |
|
| 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 | 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. | Posted | 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 | 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. | Posted | 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 | 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. | Posted | within two months of the end of high school football season |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | No Guardian Cap | The set of high school football players not wearing the Guardian Cap on their helmets | 0 | 0 | 0 | 0 |
Not provided
Not provided
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D000070625 | Brain Injuries, Diffuse |