Non Blinded Control Study of High School Athletes in Non Contact Sports
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
研究概览
简要总结
To use the Nautilus BrainPulse to compare and contrast the signal patterns from this cohort's signal patterns with those of concussed high school athletes.
详细描述
This study is a non-blinded study in high school athletes who will be presumed to no be suffering from a concussion. Healthy controls will be recruited from high school sports that are not associated with physical contact, which could generate concussions.
The primary objective of this study is to improve Jan Medical's signal analysis. Jan Medical will perform analysis.
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
- 14 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female between 14 and 19 years of age
- •Participating in non-contact sport at the Freshman, JV, and varsity level in a Bay Area High School
- •Able to provide signed informed consent or have a legally authorized representative willing to provide informed consent on the subject's behalf
排除标准
- •History, if any, of concussion or stroke
- •History, if any, of alcohol or drug abuse
- •History, if any, of mental disorder or cerebrovascular disorder
- •Pregnant women
- •Failure to comply with recording schedule
- •Not suitable for participation in the study in the opinion of the PI
- •Have suffered a concussion during the study
- •Plays a contact sport (ex- football, lacrosse, basketball, soccer, ice hockey, cross-country)
- •Related to a Jan Medical employee
结局指标
主要结局
To collect non-blinded Nautilus BrainPulseTM recordings from high school athletes who do not participate in a contact sport
时间窗: 4 months
BrainPulse recordings collected in this study will be used as an age-matched control cohort for comparison with already collected concussion data that is under development for identifying a concussion algorithm. The device recordings will be visually compared for similarities and differences using data mining practices looking for features that are consistent between the concussion subjects and healthy normals.
次要结局
未报告次要终点