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
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •High school football players unwilling or unable to have an MRI
研究组 & 干预措施
Guardian Cap
The set of high school football players wearing the Guardian Cap on their helmets
干预措施: Guardian Cap (Device)
No Guardian Cap
The set of high school football players not wearing the Guardian Cap on their helmets
结局指标
主要结局
MRI Brain SWI and FLAIR Lesions Pre and Post High School Football Season With and Without the Guardian Cap
时间窗: 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
次要结局
- 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)
- 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)
研究者
Paul Isenbarger
Diagnostic and Interventional Radiologist
Mosaic Life Care