Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy

Condition(s) studied

Investigational drug(s) / intervention(s)

Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography: Use Magnetoencephalography and Stereo-electroencephalography/Electrocorticography in the preoperative assessment of children with drug-resistant epilepsy, particularly in identifying the seizure focus.

Stereo-electroencephalography/Electrocorticography: Use Stereo-electroencephalography/Electrocorticography in the preoperative assessment of children with drug-resistant epilepsy, particularly in identifying the seizure focus.

Study summary

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:

1. How consistent is MEG with SEEG/ECoG in locating the epileptic focus in children with refractory epilepsy?
2. What is the clinical efficacy of MEG in identifying epileptic foci?

Participants will:

1. 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.
2. Be followed up at 1, 3, 6, and 12 months after surgery to assess seizure control, neurological function, and quality of life.

Eligibility

Primary outcome measure(s)

• Agreement in Epileptogenic Zone Localization Between Magnetoencephalography (MEG) and Stereoelectroencephalography/Electrocorticography (SEEG/ECoG) (Kappa Coefficient) — 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.

Trial sites (1)

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