Refractory Epilepsy in ChildrenNCT07064421
Non-Helium Magnetoencephalography in Pediatric Refractory Epilepsy
An observational study of Refractory Epilepsy in Children, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Refractory Epilepsy in Children
- What is being tested?
- Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography and Stereo-electroencephalography/Electrocorticography
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2024to 31 Dec 2027
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric patients of Guangzhou Women and Children's Medical Center
Who may be able to join
- Age range: 3-18 years old;
- Clinically diagnosed with refractory epilepsy;
- Capable of cooperating with magnetoencephalography evaluation and recording.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangzhou Women and Children's medical center
Guangzhou, Guangdong, 511399
Wenhao Zhou, Medical Doctor, +86-020-81886332, 15625984282@163.com
About this study
Official title: Non-Helium Magnetoencephalography for Clinical Management of Refractory Epilepsy in Children: An Observational Cohort Study
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:
Read more
- How consistent is MEG with SEEG/ECoG in locating the epileptic focus in children with refractory epilepsy?
- What is the clinical efficacy of MEG in identifying epileptic foci?
Participants will:
- 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.
- 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
- Being tested
- Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography, Stereo-electroencephalography/Electrocorticography
- Keywords
- Epilepsy, Magnetoencephalography
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetoencephalography plus Stereo-electroencephalography/ElectrocorticographyDiagnostic 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/ElectrocorticographyDiagnostic test
Use Stereo-electroencephalography/Electrocorticography in the preoperative assessment of children with drug-resistant epilepsy, particularly in identifying the seizure focus.
| Study group | Role | What they receive |
|---|---|---|
| Case | Participants in the case group will undergo both MEG and SEEG/ECoG for preoperative assessment. Receives: Diagnostic Test: Magnetoencephalography plus Stereo-electroencephalography/Electrocorticography | |
| Control | Patients in the control group will undergo only SEEG/ECoG before surgery. Receives: Diagnostic Test: Stereo-electroencephalography/Electrocorticography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 12 months after surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2025
- Study start5 Nov 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory Epilepsy in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing X-Magtech Technology Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07064421
- Sponsor's protocol ID
- 446A01
- Status last verified
- Jul 2025
- First submitted
- 26 Feb 2025
- Last updated
- 14 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Helium Magnetoencephalography for Clinical Management of Refractory Epilepsy in Children: An Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07064421
- Acronym / sponsor ID
- 446A01
- Conditions
- Refractory Epilepsy in Children
- Keywords
- Epilepsy, Magnetoencephalography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Collaborators
- Beijing X-Magtech Technology Limited
- Study start
- 5 Nov 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- How consistent is MEG with SEEG/ECoG in locating the epileptic focus in children with refractory epilepsy?
- What is the clinical efficacy of MEG in identifying epileptic foci?
Participants will:
- 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.
- Be followed up at 1, 3, 6, and 12 months after surgery to assess seizure control, neurological function, and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Diagnostic Test: Magnetoencephalography plus Stereo-electroencephalography/ElectrocorticographyParticipants in the case group will undergo both MEG and SEEG/ECoG for preoperative assessment. |
| Control | – | Diagnostic Test: Stereo-electroencephalography/ElectrocorticographyPatients in the control group will undergo only SEEG/ECoG before surgery. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric patients of Guangzhou Women and Children's Medical Center
Key inclusion criteria (3 listed)
- Age range: 3-18 years old;
- Clinically diagnosed with refractory epilepsy;
- Capable of cooperating with magnetoencephalography evaluation and recording.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetoencephalography plus Stereo-electroencephalography/ElectrocorticographyUse Magnetoencephalography and Stereo-electroencephalography/Electrocorticography in the preoperative assessment of children with drug-resistant epilepsy, particularly in identifying the seizure focus. | Diagnostic test | Case |
| Stereo-electroencephalography/ElectrocorticographyUse Stereo-electroencephalography/Electrocorticography in the preoperative assessment of children with drug-resistant epilepsy, particularly in identifying the seizure focus. | Diagnostic test | Control |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Epilepsy in Children, run by Guangzhou Women and Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ye Song, Medical Doctor (+86-020-81886332, 15625984282@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement in Epileptogenic Zone Localization Between Magnetoencephalography (MEG) and Stereoelectroencephalography/Electrocorticography (SEEG/ECoG) (Kappa Coefficient) (time frame: From enrollment to 12 months after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2025.