NCT01202669已完成不适用
Heart Rate Changes in Subjects With Epilepsy During an Epilepsy Monitoring Unit Admission
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 98
- 试验地点
- 2
- 主要终点
- Collection of physiologic data during an Epilepsy Monitoring Unit (EMU) stay
研究概览
简要总结
The purpose of this study is to collect continuous observational data during a clinical Epilepsy Monitoring Unit evaluation.
详细描述
Observational, unblinded, non-randomized, multisite study designed to collect data on up to 500 subjects undergoing evaluation for epilepsy in EMUs. Subjects currently enrolled or that previously participated in this study may be eligible for the E-30-S sub-study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients enrolled in the study must meet all of the following criteria:
- •Patient has a clinical diagnosis of epilepsy requiring evaluation in an epilepsy monitoring unit (EMU).
- •Patient likely requires an EMU evaluation for a period of at least 24 hours.
- •Patient is currently taking at least one antiepileptic medication.
- •Patient must be in good general health and fully ambulatory.
- •Patient or guardian must be willing and able to complete informed consent/assent and HIPAA authorization.
排除标准
- •Patients who meet any of the following criteria are not eligible to be enrolled in the study:
- •Patients with severe psychiatric disease that in the investigator's judgment would prevent the patient's successful completion of the study.
- •Patients with a history of status epilepticus.
- •Patients prescribed drugs specifically for a cardiac or autonomic disorder that in the investigator's opinion would affect heart rate response. Drugs with secondary cardiac or autonomic actions are allowed.
- •Patients with cardiovascular arrhythmias or cardiac disease that would preclude the ability to detect intrinsic changes in heart rate due to exercise, stress, or seizure. This would include but not be limited to chronic atrial fibrillation, chronotropic incompetence, and permanent cardiac pacemaker implantation.
- •Patients with a history of dependence on alcohol or narcotic drugs within the past 2 years as defined by DSM IV-R.
结局指标
主要结局
Collection of physiologic data during an Epilepsy Monitoring Unit (EMU) stay
时间窗: up to 7 days
To collect continuous observational video, electroencephalogram (EEG), electrooculogram (EOG), and electrocardiogram (ECG) data during ictal and non-ictal events occurring over a clinical EMU evaluation.
次要结局
未报告次要终点
研究者
研究点 (2)
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