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NCT Number: NCT07064421

Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy

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.

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Key information

Conditions

Refractory Epilepsy in Children Brain Diseases Central Nervous System Diseases Epilepsy Nervous System Diseases

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou Women and Children's medical center

Guangzhou, Guangdong, 511399, China

Location status: Recruiting

Location contact

Wenhao Zhou, Medical Doctor

CONTACT

[email protected]

+86-020-81886332

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography

Diagnostic Test

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

Diagnostic Test

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

Primary outcomes

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ye Song, Medical Doctor

CONTACT

[email protected]

+86-020-81886332

Sponsors and collaborators

Lead sponsor

Guangzhou Women and Children's Medical Center

Other

Collaborators

  • Beijing X-Magtech Technology Limited

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jul 14, 2025
Registry last updated
Jul 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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