Detecting PNES With Single-channel sEMG
试验速览
- 阶段
- 不适用
- 入组人数
- 71
- 试验地点
- 6
- 主要终点
- Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.
研究概览
简要总结
This is a prospective, comparative, multicenter study of subjects being admitted for standard of care therapy in Epilepsy Monitoring Units in the Veteran's Affair (VA) Medical Centers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a history of suspected epileptic seizures with upper extremity motor involvement, or PNES with upper extremity motor involvement.
- •Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- •Male or Female between the ages 22 to
- •If female and of childbearing potential, has a negative pregnancy test and must not be nursing.
- •Can understand and sign written informed consent, or will have a parent or a legally authorized representative (LAR) who can do so, prior to the performance of any study assessments.
- •Subject and/or Primary Caregiver must be competent to follow all study procedures.
- •Subject/LAR consents to the use of vEEG files, including video/audio recordings, for purposes of this research study.
排除标准
- •Intracranial EEG electrodes are being used.
结局指标
主要结局
Test an independent group of epileptologist's ability to classify motor events between epileptic or non-epileptic using sEMG and audio.
时间窗: 1 year
To test the null hypothesis that three independent epileptologists categorize, by majority vote, epileptic seizures and psychogenic non-epileptic seizures (identified utilizing vEEG review) correctly in no more than 70% of cases using sEMG and audio. We aim to test the null hypothesis that the epileptologists categorize epileptic seizures and psychogenic non-epileptic seizures correctly in no more than 70% of cases. The observed rate of correct classification will be compared to the rate of 70% under the null hypothesis using a two-sided binomial exact test.
次要结局
- To test the Brain Sentinel® Seizure Monitoring and Alerting System's ability to classify motor events as epileptic or non-epileptic.(1 Year)