Validation of Brain Function Assessment Algorithm for mTBI From Injury to Rehabilitation in College Athletes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 420
- 试验地点
- 8
- 主要终点
- Likelihood of being concussed
研究概览
简要总结
This study is Part 1 of data collection from 18-25 years old subject population for validation of previously derived algorithms. This data will be combined with that collected under NCT03671083 (Part 2 with subject age range 13-25 years) for the final analyses of validation of the algorithms.
详细描述
EEG, neurocognitive performance and clinical data will be collected at time of injury (within 3 days) at clinically determined Return to Play (RTP) and 45 days after RTP, for the purpose of independently validating the performance of the algorithms developed in prior studies (NCT02477943, NCT02661633 and NCTXXXXXX). Data collected under this study will be combined with that collected under NCT03671083 for the final analyses of prospective algorithm performance in an independent population ages 13-25 years. Subjects will come from the sports and other populations of concussed individuals. They will be matched with controls i.e. not head injured subjects who will also undergo the same set of tests and the same time intervals as the injured subjects. An additional pool of uninjured (not head injured) subjects will be collected who will be assessed at a single time point.
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
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Previously enrolled as an Injured or Matched Control subject in the BrainScope Algorithm Development Study
- •Current CNS active prescription medications taken daily, with the exception of medications being taken for the treatment of Attention Deficit Disorder (ADD) or Attention Deficit Hyperactivity Disorder (ADHD)
- •Forehead, scalp or skull abnormalities that prevents headset application or EEG data collection
- •History of brain surgery or neurological disease
- •Pregnant women
- •Do not speak or read English
- •Loss of consciousness ≥ 20 minutes related to the concussion injury - for injured subjects only
- •Prior history of concussion in the last year - for Matched Control subjects only
结局指标
主要结局
Likelihood of being concussed
时间窗: 6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP
Sensitivity and specificity forthe identification of the likelihood of concussion/mTBI at the time of injury using a multi-modal EEG-based Concussion Index (CI)
次要结局
- Significance of change over time(6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP)
- Prediction of prolonged recovery(6 months for data acquisition, with each patient studied from time of injury to 45 days after RTP)