NCT02776462已完成不适用
Use of Eye Movement Tracking to Detect Oculomotor Abnormality in Traumatic Brain Injury Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 321
- 试验地点
- 2
- 主要终点
- A change in metrics of eye movement that enable positive concussion detection using BOX Score.
研究概览
简要总结
The purpose of this study is to determine the sensitivity and specificity of an aid in assessment of concussion based on eye-tracking, in comparison to a clinical reference standard appropriate for the Emergency Department (ED) or concussion clinic.
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
- 5 Years 至 67 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent.
- •Be between the ages of 4 and 67 years old.
- •Have a diagnosis of traumatic brain injury with a potential for concussion.
- •Subjects must have baseline vision correctable to within 20/500 bilaterally.
- •Subjects must have intact ocular motility.
- •Subjects must have ability to provide a complete ophthalmologic, medical and neurologic history as well as medications/drugs/alcohol consumed within the 24 hours prior.
排除标准
- •ER visit has been more than 2 weeks since the injury which may have caused the concussion.
- •Have received penetrating trauma or have a head CT demonstrating evidence of acute brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- •Suffering burns, anoxic injury or multiple/extensive injuries resulting in any medical, surgical or hemodynamic instability.
- •Blind (no light perception), are missing eyes, do not open eyes.
- •It is pertinent that subjects be able to detect light and have both eyes in order for the eye tracking data to be effective and significant.
- •Previous history of: ocular motility dysfunction or extensive prior eye surgery.
- •Any physical or mental injury or baseline disability rendering task completion difficult.
- •Obvious intoxication or blood alcohol level greater than 0.2.
结局指标
主要结局
A change in metrics of eye movement that enable positive concussion detection using BOX Score.
时间窗: Immediately after eye tracking, within 2 weeks of injury
A True Positive rate for identifying Concussion as compared to a Clinical Reference standard.
次要结局
- Change in Cognitive Function and Symptom Severity during Recovery as Measured with a Clinical Reference Standard for Concussion.(Immediately before eye tracking, between 1 week and 109 weeks post injury)
研究者
研究点 (2)
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