Electrophysiological Biomarkers During Invasive Monitoring of Mesial Temporal Lobe Epilepsy Patients.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Change in Intracranial EEG Recording: Synchrony From Baseline
研究概览
简要总结
The investigators plan to enroll individuals with medical temporal lobe epilepsy who are undergoing surgical workup with clinically implanted intracranial electrodes. The study intends to administer computerized memory tasks and stimulation during the intracranial Electroencephalography (EEG) monitoring period.
详细描述
This is a nonrandomized interventional trial that will apply brain stimulation via clinically implanted intracranial electrodes to subjects with medial temporal lobe epilepsy with the purpose of identifying biomarkers related to the pre-ictal state; to perform an acute parameter search to determine the stimulation pattern that most effectively modifies these biomarkers and to identify changes in memory (free recall) during asynchronous distributed multi-electrode stimulation (ADMES).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of signed and dated informed consent form
- •Male or female, aged 18-65
- •Diagnosed with lesional or non-lesional mesial temporal (hippocampal) seizure onset confirmed on SEEG monitoring
- •Implanted with depth electrodes for localization of seizure onset with multiple hippocampal electrode arrays
- •Exclusion criteria:
- •Any patient who is unwilling or unable to provide consent
- •Women who are pregnant
- •Patients under 18 years
- •Incarcerated persons
排除标准
- 未提供
结局指标
主要结局
Change in Intracranial EEG Recording: Synchrony From Baseline
时间窗: Baseline, up to 6 weeks postintervention
Synchrony will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates synchrony during the preictal, ictal or post ictal states. Synchrony is a measure of how any pair of regions communicate with one another. Synchrony is measured as the correlation \[-1 to 1\] between two time series. The investigators anticipate that a decrease in synchrony (correlation approaching 0) is associated with improved outcome.
Change in Intracranial EEG Recording: Spectral Power From Baseline
时间窗: Baseline, up to 6 weeks postintervention
Spectral power will be compared between baseline/sham and stimulation trials to determine if asynchronous stimulation modulates spectral power during the preictal, ictal or post ictal states. Spectral power is measured in microvolts. A change in either direction from baseline is associated with a better outcome.
次要结局
- Changes in Memory During Brain Stimulation From Baseline(Baseline, up to 6 weeks postintervention)