Correlate of Surface Electroencephalogram (EEG) With Implanted EEG Recordings (ECOG)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Electrocardiogram (EEG) change before, during, and after anesthesia.
研究概览
简要总结
Improve understanding of the correlation between surface EEG and implanted EEG recordings
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female subjects 18 years of age or older.
- •English or Spanish Speaking
- •Subjects who have been previously diagnosed with intractable epilepsy and require implantation of invasive electrophysiological recordings as part of their routine clinical presurgical workup.
排除标准
- •Patients with skin abnormalities at the planned application sites that would interfere with sensor or electrode applications.
- •Patients with pre-existing conditions and/or co-morbidities that would prohibit them from participating in the study due to unacceptable risks to their health and well-being, as determined by the Principal Investigator (PI).
- •Patients who the PI deems ineligible at the PI's discretion
- •Pregnant patients
研究组 & 干预措施
ECOG and EEG Sensor
Study subjects are neurosurgical patients with medically refractory epilepsy who will have implanted with intracranial ECoG electrodes. The electrodes will be used during a period of inpatient monitoring to identify resectable seizure foci.
干预措施: EEG (Device)
ECOG and EEG Sensor
Study subjects are neurosurgical patients with medically refractory epilepsy who will have implanted with intracranial ECoG electrodes. The electrodes will be used during a period of inpatient monitoring to identify resectable seizure foci.
干预措施: ECOG (Device)
结局指标
主要结局
Electrocardiogram (EEG) change before, during, and after anesthesia.
时间窗: Up to 48 hours. Specific time points are dependent on patient clinical events.
Patient subjective level of consciousness during and after anesthesia administration will be assessed using response to verbal stimuli, response via button press, reported subjective level of consciousness, and/or response to memory tests (i.e. demonstration of explicit memory recall). Around loss and recovery of consciousness time points (e.g. induction or emergence from anesthesia or when patient falls asleep or wakes up during 24 hour postoperative time points) level of consciousness will be assessed in brief intervals (seconds) until patient no longer responds or begins to respond. Data collected before, after, and during seizure activity if a patient loses consciousness or has diminished consciousness may also be compared.
次要结局
- Electrocardiogram (EEG) change during any seizures.(Up to 48 hours. Specific time points are dependent on patient clinical events.)
- Electrocardiogram (EEG) change during any changes in consciousness.(Up to 48 hours. Specific time points are dependent on patient clinical events.)
研究者
David R. Drover
Principle Investigator
Stanford University