NCT04381767已完成不适用
EYE-SYNC Concussion Classification Study
Sync-Think, Inc.1 个研究点 分布在 1 个国家目标入组 1,303 人开始时间: 2018年12月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,303
- 试验地点
- 1
- 主要终点
- A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
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 sport-related concussion evaluation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women actively engaged in competitive athletics
- •Eye tracking measurements and SCAT5 evaluations are collected within 3-day window
- •Eye tracking measurements and SCAT5 evaluations are collected within 3 days of injury
排除标准
- •Prior enrollment (subjects may only enroll once)
- •POOR eye tracking data quality
- •Subjects without reported injury detailing alteration of consciousness (AOC) or altered mental status (AMS) defined as self-report, witness report or the following responses to the SCAT5 SSS: "Difficulty Remembering" ≥ 4 or "Confusion" ≥ 4, or scored less than 23 on the SCAT5 Standardized Assessment of Concussion (SAC) or greater than 25 on the SCAT5 Symptom Severity Score (SSS)
- •EYE-SYNC smooth pursuit standard deviation of tangential error (SDTE) variance scores < 2.0
结局指标
主要结局
A change in metrics of eye movement that enable positive concussion detection using EYE-SYNC metrics
时间窗: 3 days
A True Positive and True Negative rate for identifying Concussion as compared to a Clinical Reference standard.
次要结局
未报告次要终点
研究者
研究点 (1)
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