Understanding Concussion/Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 477
- 试验地点
- 5
- 主要终点
- Accuracy of Concussion Diagnosis
研究概览
简要总结
Using the Blink Reflexometer, athletes are scanned if they are potentially thought to have a concussion during a game or practice.
详细描述
In a blinded trial, any patient who during a game or practice situation had head contact, thus possible Traumatic Brain Injury (TBI) aka Concussion, in addition to the current approved protocols, patients are scanned with the Blink Reflexometer. Results are not available until the end of the season, thus eliminating the potential of someone relying on the results. The Blink Reflexometer uses 5 puffs of air on the side of the eye over 20 seconds. The air causes a blink reflex which is being correlated to a concussion. The results of the blink post concussion are compared to a baseline scan taken at the beginning of the season.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Read, understand and sign patient consent (parent approval needed when pt is under 18yo)
排除标准
- •Diagnosed concussion in past 4 weeks
- •Ingesting any drugs banned by the US Anti-doping Association (USADA)
- •Never prior diagnosed with a neurological abnormality, including Alzheimer's, MS, Huntington's, Epilepsy, etc.
结局指标
主要结局
Accuracy of Concussion Diagnosis
时间窗: Data unblinded May 1, 2018 or at completion of season, which ever comes first.
The results from the Blink machine should match the physicians diagnosis.
次要结局
- Contributing Factors(Data unblinded May 1, 2018 or at completion of season, which ever comes first.)
- Average Baseline(Data unblinded May 1, 2018 or at completion of season, which ever comes first.)