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临床试验/NCT06575413
NCT06575413已完成不适用

Investigating the Role and Electrophysiological Characteristics of the Human Claustrum Based on SEEG

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2024年5月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
8
试验地点
1
主要终点
Patients Clinical responses Rating

研究概览

简要总结

This single-center prospective study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from 14~65-year-old patients with drug-resistant epilepsy.

详细描述

Stereoelectroencephalography (SEEG) is a method for recording electrical activity from deep brain structures using implanted depth electrodes to provide a three-dimensional view of neuronal activity.

Direct Electrical Stimulation (DES) is a neurosurgical technique that involves delivering electrical impulses to specific brain regions through implanted electrodes to map critical functional areas and to study the connectivity of brain regions.

This study aims to investigate the electrophysiological characteristics and functions of the human claustrum by analyzing clinical, imaging, and electrophysiological data from patients aged 14 to 65 implanted intracranial electrodes , with a specific focus on electrodes targeting the claustrum. This research forms part of a broader initiative to explore the functions of cortical and subcortical regions based on SEEG.

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
14 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • The patients were diagnosed with drug-resistant epilepsy.
  • The patients underwent stereoelectroencephalography (SEEG) implantation for pre-surgical evaluation of epilepsy, with at least one electrode target reaching the claustrum
  • Participants/parents/legal guardian provide informed consent for inclusion

排除标准

  • Subjects that experience surgical complications during the implant procedure will be excluded from the study

结局指标

主要结局

Patients Clinical responses Rating

时间窗: During the trial(up to 3 hours for each subject)

Researchers categorized patients' clinical responses as normal, mild, moderate, or severe based on their subjective clinical response.

EEG power in spectral frequency bands

时间窗: During the trial(up to 3 hours for each subject)

Using SEEG-implanted electrodes, the investigators applied electrical stimulation of varying intensities to the CLA while observing and recording EEG power changes across six spectral frequency bands during the pre-stimulation, stimulation, and post-stimulation periods. EEG Frequency Bands * delta (1-4 Hz) * theta (5-8 Hz) * alpha (9-12 Hz) * beta (13-30 Hz) * low gamma (31-70 Hz) * high gamma (71-150 Hz)

The root mean square (RMS) value of Claustrum-Cortical Evoked Potentials

时间窗: During the trial(up to 3 hours for each subject)

All cortical-evoked responses were averaged by time-locking the recordings to the onset of each electrical stimulus (zero) off-line, within a time window of -200 to +400 mses, to quantify the morphology. The N1 peak, identified as the first negative deflection distinguishable from the stimulus artifact, was the primary focus due to its clear visibility and reproducibility across different stimulations. The root mean square (RMS) value will be calculated for different cortical locations during time windows that encompass both the N1 peak(early response time time window) and the baseline. A paired one-sample t-test will be used to compare the RMS values in the early response time window across different cortical sites with the RMS values in the baseline.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Liankun_Ren

Professor

Xuanwu Hospital, Beijing

研究点 (1)

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