An Exploratory Trial Using sEMG to Differentiate PNES From Epileptic Seizures
试验速览
- 阶段
- 不适用
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- 3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3)
研究概览
简要总结
This is an observational study of subjects receiving standard of care therapy, while admitted to Epilepsy Monitoring Unit, Department of Neurology, General Hospital Hietzing with Neurological Center Rosenhügel. Additional monitoring provided by the SPEAC System will be compared to the gold standard, vEEG. The SPEAC System is being evaluated while being used in adjunct to standard of care.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a suspected history of PNES with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement.
- •Is being admitted to a hospital for routine vEEG monitoring related to seizures.
- •Male or female between the ages of 18-
- •If female and of childbearing potential, has a negative pregnancy test.
- •Can understand and sign written informed consent prior to the performance of any study assessments.
- •Subject must be competent to follow all study procedures.
排除标准
- •1.Intracranial EEG electrodes are being used.
结局指标
主要结局
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG, using a majority rules approach (2 out of 3)
时间窗: 5 days
The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using vEEG review. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG).
3 independent physicians' abilities to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG, using a majority rules approach (2 out of 3)
时间窗: 5 days
The primary endpoint is to test a physician's ability to differentiate between epileptic events (with upper extremity motor involvement) and PNES (with upper extremity motor involvement) using sEMG recorded by the SPEAC System. PNES and epileptic seizures will initially be identified, described, and documented following routine clinical care (vEEG). The sEMG record will be evaluated to identify PNES, displaying upper extremity motor components, and epileptic seizures, displaying upper extremity (UE) motor components. It is anticipated that \> 70% of PNES with UE motor involvement identified by vEEG will be identified by sEMG recordings as well.
次要结局
- To evaluate the System's ability to detect GTC seizures, as compared to vEEG monitoring(5 days)