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临床试验/NCT06524479
NCT06524479招募中不适用

Investigating the Functional Characteristics During Wakefulness and Sleep Based on SEEG

Xuanwu Hospital, Beijing1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
SEEG recordings with SPES during daytime and sleeptime

研究概览

简要总结

This study aims to collect electrophysiological and clinical data from patients aged 14-65 with drug-resistant epilepsy who underwent SEEG. The collected data will be analyzed to investigate the functional connectivity during wakefulness and sleep states.

详细描述

Sleep serves as a fundamental physiological state whose disruption has profound implications for neurological health. The daily alternation between sleep and wakefulness reflects an intrinsic circadian rhythm that orchestrates critical fluctuations in cortical excitability and functional connectivity throughout the brain. The cerebral cortex, comprising approximately 80% of total brain volume, forms the neural substrate for higher-order cognitive functions including sensory perception, executive control, and memory processes. Importantly, sleep acts as a global brain modulator that dynamically reorganizes patterns of neural communication across distributed cortical and subcortical networks.

Stereoelectroencephalography (SEEG) provides direct access to intracranial electrophysiological activity with exceptional spatiotemporal resolution. When combined with single-pulse electrical stimulation (SPES), this powerful methodology enables quantitative assessment of inter-regional connectivity through analysis of evoked potentials, allowing precise characterization of both connection strength and directionality. This integrated approach offers unique opportunities to examine how different vigilance states modulate cortical excitability and reorganize functional brain networks, particularly in clinical populations with neurological disorders. The ability to track state-dependent changes in network dynamics provides crucial insights into both normal brain function and pathological conditions.

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

  • Drug-resistant focal epilepsy
  • Justified SEEG exploration in the context of presurgical assessment of epilepsy
  • Subjects will be a part of the epilepsy-monitoring unit for long-term SEEG recordings and analysis
  • Written non-opposition to study participation

排除标准

  • Pregnant women (Contraindication to SEEG exploration)
  • Subjects that experience surgical complications during the implant procedure will be excluded from the study

结局指标

主要结局

SEEG recordings with SPES during daytime and sleeptime

时间窗: 48 hours

Single-pulse electrical stimulation (SPES) serves as an effective dynamic marker for mapping functional brain connectivity. The stimulation parameters were set at 0.05 Hz, single biphasic pulses, 90 μs per phase, 4 mA.

次要结局

  • Dynamic 11-Deoxycortisol levels(48 hours)
  • Dynamic melatonin levels(48 hours)
  • Dynamic cortisone levels(48 hours)
  • Dynamic 21-Deoxycortisol levels(48 hours)
  • Dynamic 18-Hydroxycortisol levels(48 hours)
  • Dynamic 18-Oxocortisol levels(48 hours)

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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