Longitudinal Brain Health in Youth Tackle Football Players
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Impact Monitoring (g force)
研究概览
简要总结
The purpose of this study is to determine the neurologic and cognitive effects of playing tackle football in grade school and high school.
During contact practices and games, players wear a football helmet containing an impact sensor. Before and after each season, players complete neurological testing to measure several different aspects of brain function.
Two groups of football players will be in the study:
5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league (about 70 players).
Varsity football players from Brighton High School (about 70 players per year).
The study begins in July 2016 and will continue for 4 years (through the winter of 2020).
详细描述
Football players wear a football helmet containing the InSite Impact Response System that measures when, how hard, and where the helmet is hit. Coaches (or athletic trainer) are notified of threshold impacts via a sideline handheld device.
Each year pre and post-season, subjects will complete several tests of brain function during a clinic visit. These tests are listed in the "secondary outcomes" section.
Specific Aims:
- To quantify the cumulative head impact burden during consecutive seasons of youth tackle football and high school football.
- To detect impairment in neurologic and cognitive function from playing youth tackle football and high school football.
- To use cumulative head impact burden to predict the development of neurologic and neurocognitive impairment.
- To compare the effect of head impacts on youth tackle football players verses high school football players.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 9 Years 至 19 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male football players 9-19 years of age at time of enrollment.
- •Youth Football:
- •5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league.
- •High School Football:
- •Varsity Brighton High School football players.
排除标准
- •History of moderate or severe traumatic brain injury. This is defined as loss of consciousness >30 minutes or amnesia >24 hours.
- •Hearing problem preventing completion of the study testing.
- •Legal blindness, preventing completion of the study testing.
- •Non-English speaking subjects, preventing completion of the study testing.
- •Ward of the State.
结局指标
主要结局
Impact Monitoring (g force)
时间窗: The football season runs from early August through late October or November (3-4 months)
Each subject in the study group will be fitted with a football helmet containing the InSite impact response system. Subjects will be monitored for impacts during all contact practices and games.
次要结局
- Neurological history(Occurs pre-season & post season and continues for 4 years)
- Neurological physical examination(Occurs pre-season & post season and continues for 4 years)
- Vestibular/Ocular Motor Screening (VOMS) test(Occurs pre-season & post-season and continues for 4 years)
- MimicBalance!(Occurs pre-season & post-season and continues for 4 years)
- Strength and Difficulties Questionnaire(Occurs pre-season & post-season and continues for 4 years)
- SWAN ADHD Questionnaire(Occurs pre-season & post season and continues for 4 years)
- Cogstate(Occurs pre-season & post-season and continues for 4 years)
- Pen and paper neuropsychological tests(Occurs pre-season & post-season and continues for 4 years)
- Brain Network Activation (BNA) EEG test(Occurs pre-season & post-season and continues for 4 years)
研究者
Sean Rose, M. D.
Director of Clinical Research and Regional Director
The CORE Institute