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Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07064421
Enrollment
100
Registered
2025-07-14
Start date
2024-11-05
Completion date
2027-12-31
Last updated
2025-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory Epilepsy in Children

Keywords

Epilepsy, Magnetoencephalography

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. 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_TESTMagnetoencephalography 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_TESTStereo-electroencephalography/Electrocorticography

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

Sponsors

Beijing X-Magtech Technology Limited
CollaboratorUNKNOWN
Guangzhou Women and Children's Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

1. Age range: 3-18 years old; 2. Clinically diagnosed with refractory epilepsy; 3. Capable of cooperating with magnetoencephalography evaluation and recording.

Exclusion criteria

1. Patients with serious comorbidities or neurological or psychiatric disorders that affect magnetoencephalography examination. 2. Patients using drugs that affect central nervous system function; 3. Patients who are not suitable for surgical procedures; 4. Patients with progressive neurological disorders.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

China

Contacts

Primary ContactYe Song, Medical Doctor
15625984282@163.com+86-020-81886332

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026