Non-Helium Magnetoencephalography for Clinical Management of Refractory Epilepsy in Children: An Observational Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Agreement in Epileptogenic Zone Localization Between Magnetoencephalography (MEG) and Stereoelectroencephalography/Electrocorticography (SEEG/ECoG) (Kappa Coefficient)
研究概览
简要总结
The goal of this observational study is to evaluate the effectiveness of Magnetoencephalography (MEG) in the preoperative assessment of children with refractory epilepsy, particularly in identifying the seizure focus, and to compare it with the gold standard methods of Stereo-electroencephalography (SEEG) and Electrocorticography (ECoG).
The main questions this study aims to answer are:
- How consistent is MEG with SEEG/ECoG in locating the epileptic focus in children with refractory epilepsy?
- What is the clinical efficacy of MEG in identifying epileptic foci?
Participants will:
- Be divided into 2 groups: the case group and the control group. Participants in the case group will undergo both MEG and SEEG/ECoG for preoperative assessment, while patients in the control group will undergo only SEEG/ECoG before surgery.
- Be followed up at 1, 3, 6, and 12 months after surgery to assess seizure control, neurological function, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 3-18 years old;
- •Clinically diagnosed with refractory epilepsy;
- •Capable of cooperating with magnetoencephalography evaluation and recording.
排除标准
- •Patients with serious comorbidities or neurological or psychiatric disorders that affect magnetoencephalography examination.
- •Patients using drugs that affect central nervous system function;
- •Patients who are not suitable for surgical procedures;
- •Patients with progressive neurological disorders.
结局指标
主要结局
Agreement in Epileptogenic Zone Localization Between Magnetoencephalography (MEG) and Stereoelectroencephalography/Electrocorticography (SEEG/ECoG) (Kappa Coefficient)
时间窗: From enrollment to 12 months after surgery.
This outcome measures the agreement between preoperative MEG and SEEG/ECoG (gold standard) in localizing the epileptogenic zone. Consistency will be quantified using Cohen's Kappa coefficient (κ) with 95% confidence intervals. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) will be calculated. Data aggregation will compare MEG-derived localization (categorized by brain regions, e.g., temporal lobe, frontal lobe) with intraoperative SEEG/ECoG findings. Statistical analysis will be performed using SPSS 27.0.
次要结局
未报告次要终点