Investigations of Amygdala Function Using Neurophysiological Recording and Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 2
- 主要终点
- ECoG (ElectroCorticoGraphy) frequency changes
研究概览
简要总结
This study aims to specifically examine the in vivo electrophysiology and effects of direct stimulation of the human amygdala during conditioned and evoked fear. Investigators will also examine amygdala electrophysiology and the effects of stimulation during tasks to examine the effects of reward on fear memory.
This study will recruit subjects with a history of temporal lobe epilepsy (TLE) who have undergone neurosurgical implantation with FDA-approved, NeuroPace RNS devices for treatment of seizures. These patients provide a unique cohort with (Responsive Neurostimulation) RNS devices capable of both recording and stimulating the amygdala during performance of fear-based, behavioral tasks.
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
- •be between age 18-65 years of age
- •participants must have received the Neuropace RNS implant to treat their seizures
- •have comprehension of instructions in the English language
- •be on a stable dose of medications for their epilepsy
- •have received the RNS System for Temporal Lobe Epilepsy
- •have capacity to provide informed consent
排除标准
- •significant cognitive impairment (Mini Mental Status Examination score of less than 20)
- •DSM-V diagnosis of alcohol/substance abuse (except nicotine) within the last month or a diagnosis of alcohol/substance dependence (except nicotine) within the last 6 months
- •Unable to apply EEG cap
- •History of traumatic brain injury
- •Active or high suicide risk
- •Unable to come to study site/lack of stable housing
- •is pregnant or nursing
- •Patient's treating neurologist determines that the patient's epilepsy is not stable enough to participate in this study
- •Any condition (including psychiatric) which in the judgment of the Investigator would prevent the subject from completion of the study
结局指标
主要结局
ECoG (ElectroCorticoGraphy) frequency changes
时间窗: 2 days
Quantify changes in ECoG measures as determined clinically by the Investigator using intracranial recordings from the Neuropace devices. Analyze changes in ECoG frequency - in resting state and ECoG throughout task and stimulation
EEG(electroencephalography) frequency changes
时间窗: 2 days
Analyze changes in frequency in Hertz- in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator. Investigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Spectral Potentials (ERSP).
ECoG (ElectroCorticoGraphy) amplitude changes
时间窗: 2 days
Quantify changes in ECoG measures as determined clinically by the Investigator.- using intracranial recordings from the Neuropace devices. Analyze changes in ECoG amplitude- in resting state and ECoG throughout task and stimulation.
EEG(electroencephalography) amplitude changes
时间窗: 2 days
Analyze change in amplitude in microvolts -in resting state EEG recording and EEG recording across all the tasks as determined clinically by the Investigator. Investigators will be analyzing stimulus-induced electrophysiological recordings, focusing on Event-Related Potentials (ERPs).
次要结局
- Electrophysiological changes in EMG(2 days)
- Electrophysiological changes in EDA(2 days)
研究者
Mahendra Bhati
Clinical Professor
Stanford University