Detecting PNES With Single-channel sEMG
试验速览
- 阶段
- 不适用
- 入组人数
- 71
- 试验地点
- 3
- 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.
研究组 & 干预措施
Subjects admitted to Epilepsy Monitoring Units in the VAMC
Subjects being monitored by standard of care, video EEG, in the Epilepsy Monitoring Units in the VAMC will all be placed on a Seizure Monitoring and Alerting System (SPEAC System).
干预措施: SPEAC System (Device)
Subjects admitted to Epilepsy Monitoring Units in the VAMC
Subjects being monitored by standard of care, video EEG, in the Epilepsy Monitoring Units in the VAMC will all be placed on a Seizure Monitoring and Alerting System (SPEAC System).
干预措施: video EEG (Device)
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)