Concussion Testing: A Novel Non-invasive Concussion Detection Device
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data
研究概览
简要总结
The purpose of this study is to establish and evaluate a distinctive signal for concussion.
详细描述
The purpose of this study is to establish a non-invasive objective measurement for the detection of concussions with the Jan Medical Device (JMD). The study will assess the ability of this device to demonstrate unique signals that correlate with concussions. The study will also test the athletes at baseline at rest and during exertion to determine if there is a difference in the signal from exertion alone. The JMD is a non-invasive band that is placed around the participants head. The JMD detects a unique pattern of signals based on displacement of the skull from changes in blood flow during individual heartbeats. The athletes will be tested longitudinally to assess to changes over time, in addition to changes after impact
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 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Junior Varsity and Varsity Players a local High School.
排除标准
- 未提供
结局指标
主要结局
A Measure Assessing the Sensitivity and Specificity Rate Based on the Nautilus Neurowave Data
时间窗: Individual assessments were made within 2 days of recording
Sensitivity (also called the true positive rate) measures the proportion of concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data. Specificity (also called the true negative rate) measures the proportion of non-concussed participants that are correctly identified as such by utilizing the information within the Nautilus Neurowave data The information that is evaluated from within this data is recognized through the computation of two parameters, R1 and R2. Both R1 and R2 are measured by computing the frequency spectrum using an FFT of the Neurowave data and computing a ratio of the signal intensities at specific higher frequencies against specific lower frequencies within that spectrum. Based on this computation, the recorded data is evaluated as coming from a concussed participant if R1 \>= 1.0 and R2 \>= 0.66 and is considered non-concussed otherwise.
次要结局
未报告次要终点