Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy

NCT07064421 | Recruiting DMC

• 1 other identifier: 446A01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.How consistent is MEG with SEEG/ECoG in locating the epileptic focus in children with refractory epilepsy?
2. 2.What is the clinical efficacy of MEG in identifying epileptic foci?
3. 3.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.
4. 4.Be followed up at 1, 3, 6, and 12 months after surgery to assess seizure control, neurological function, and quality of life.

Conditions

Refractory Epilepsy in Children

Keywords

Epilepsy; Magnetoencephalography

Outcome Measures

Primary Outcomes (1)

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

  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.

  From enrollment to 12 months after surgery.

Study Arms (2)

Case

Participants in the case group will undergo both MEG and SEEG/ECoG for preoperative assessment.

Diagnostic Test: Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography

Control

Patients in the control group will undergo only SEEG/ECoG before surgery.

Diagnostic Test: Stereo-electroencephalography/Electrocorticography

Interventions

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.

Case

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.

Control

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients of Guangzhou Women and Children's Medical Center

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangzhou Women and Children's Medical Center: lead
• Beijing X-Magtech Technology Limited: collaborator

Study Sites (1)

Guangzhou Women and Children's medical center

Guangzhou, Guangdong, 511399, China

RECRUITING

MeSH Terms

Conditions

Epilepsy

Interventions

Magnetoencephalography; Electrocorticography

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Neurological; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Central Study Contacts

Ye Song, Medical Doctor

CONTACT

+86-020-81886332; 15625984282@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: July 14, 2025
• Study Start: November 5, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: July 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)