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Recruiting NCT07064421

Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy

Observational Refractory Epilepsy in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography, Stereo-electroencephalography/Electrocorticography.
Who it may be relevant to
Registry conditions: Refractory Epilepsy in Children. Basic parameters: 3 years — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Non-Helium Magnetoencephalography for Clinical Management of Refractory Epilepsy in Children: An Observational Cohort Study

Overview

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.

Interventions

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

Primary outcome measures

  • Agreement in Epileptogenic Zone Localization Between Magnetoencephalography (MEG) and Stereoelectroencephalography/Electrocorticography (SEEG/ECoG) (Kappa Coefficient) [Time frame: From enrollment to 12 months after surgery.]

Eligibility criteria

Inclusion criteria

  • Age range: 3-18 years old;
  • Clinically diagnosed with refractory epilepsy;
  • Capable of cooperating with magnetoencephalography evaluation and recording.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • Guangzhou Women and Children's medical center — Guangzhou

Identifiers

NCT: NCT07064421 · 446A01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗