Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy

NCT ID: NCT07064421

Last Updated: 2025-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-05

Study Completion Date

2027-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Refractory Epilepsy in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Case

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

Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography

Intervention Type DIAGNOSTIC_TEST

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

Control

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

Stereo-electroencephalography/Electrocorticography

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

3 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing X-Magtech Technology Limited

UNKNOWN

Sponsor Role collaborator

Guangzhou Women and Children's Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Guangzhou Women and Children's medical center

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ye Song, Medical Doctor

Role: CONTACT

+86-020-81886332

Facility Contacts

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Wenhao Zhou, Medical Doctor

Role: primary

+86-020-81886332

Other Identifiers

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446A01

Identifier Type: -

Identifier Source: org_study_id

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