跳至主要内容
临床试验/NCT05443958
NCT05443958招募中不适用

The Role of IEEG in the Localization of EZ and Its Relationship With Prognosis

Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
120
试验地点
1
主要终点
Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups

研究概览

简要总结

The mechanism of epilepsy pathogenesis is complex and not fully defined, and about 20-30% of patients with seizures that cannot be completely controlled by drugs become drug-resistant epilepsy. For focal drug-resistant epilepsy, surgical removal of the epileptogenic zone can control seizures, but the overall seizure-free rate in the long term after surgery is 60-70%, and the results are still not satisfactory. Accurate assessment of the location and extent of the epileptogenic zone and its adequate excision are prerequisites for the success or failure of surgery. Intracranial EEG (iEEG) has been shown to be the most accurate method for determining the location and boundaries of the epileptogenic zone. It can selectively record the local cortical electrical activity through intracranial electrodes and achieve high temporal resolution for long-range recording, reliably reflecting the continuous dynamic changes of EEG during interictal and ictal periods. The in-depth analysis of iEEG can improve the efficacy of epilepsy surgery and provide important information to reveal the pathogenesis of epilepsy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
3 Years 至 70 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Complete clinical history;
  • IEEG monitoring at least one habitual seizure;
  • Follow up for at least 1 year;
  • Signed informed consent.

排除标准

  • Habitual seizures were not found in iEEG monitoring;
  • No operation was performed;
  • Lost to follow-up for various reasons within 1 year after surgery.

结局指标

主要结局

Comparison of clinical data and IEEG characteristics in the seizure-free and not seizure-free groups

时间窗: 1-2 years

Compare two groups of patients with clinical data (sex, age at onset, age at surgery, epilepsy duration, seizure lateralization/localization, MRI findings, Pathology) and EEG characteristics (contact number, EEG onset pattern, IEEG power of each frequency band, functional connectivity of each frequency band).

次要结局

未报告次要终点

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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