Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery

NCT06271785 | Recruiting

• 1 other identifier: 49RC22_0354
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 9

Brief Summary

This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children. This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues. Electrical sources are then fused on structural magnetic resonance imaging (MRI). Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI. Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%. Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data. Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI. Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected. To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles. This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG. The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome. Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.

Conditions

Epilepsy in Children

Outcome Measures

Primary Outcomes (1)

• Prediction accuracy index

  The main outcome is the prediction accuracy index, as assessed in fusing pre-op current equivalent dipoles to postop MRI, based on a tight cluster of spikes compared to the prediction accuracy index based on a loose cluster of spikes or on multiple clusters of spikes.

  24 months

Secondary Outcomes (6)

• Localization of the epileptogenic zone (Baseline)

  Baseline

• Localization of the epileptogenic zone (After Surgery)

  24 months (= V3)

• preoperative accuracy of epileptogenic source localization

  12 months (= V2)

• prognostic value of HFO

  24 months (= V3)

• Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate

  3 months (= V1)

Study Arms (1)

HR-EEG recording

EXPERIMENTAL

Diagnostic Test: HR-EEG recording

Interventions

HR-EEG recording DIAGNOSTIC_TEST

All participants will have a HR-EEG recordings. It will be made at rest. Nap-like sleep is encouraged, but no sedatives will be given. Recording time will not exceed two hours.

HR-EEG recording

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age≥2 and \<17 years;
• Drug-resistant focal epilepsy (failure of at least 2 well-conducted drug trials);
• Phase 1 pre-op evaluation with scalp video-EEG recording, MRI and PET-FDG suggesting that the patient could be a good candidate for epilepsy surgery;
• Recent scalp EEG record (within 12 months) showing the presence of interictal spikes;
• High-quality and recent (within 6 months) structural MRI with 3D-T1 sequences covering the whole brain and the scalp available.

You may not qualify if:

• Behavioral deficits making recording of scalp EEG impossible without sedation;
• Informed consent form not signed by the parents;
• Patient not affiliated to a social security system

Sponsors & Collaborators

• University Hospital, Angers: lead

Study Sites (9)

Angers university hospital, Pédiatric department

Angers, 49000, France

RECRUITING

Lille University Hospital, Clinical Neurophysiology Department

Lille, 59000, France

NOT YET RECRUITING

Civil Hospices of Lyon, Functional Neurology Department

Lyon, 69677, France

NOT YET RECRUITING

Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department

Marseille, 13000, France

NOT YET RECRUITING

Nancy University Hospital, Neurology Department

Nancy, 54000, France

NOT YET RECRUITING

Paris Neck University Hospital, Pediatric department

Paris, 75015, France

NOT YET RECRUITING

Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations

Paris, 75019, France

NOT YET RECRUITING

Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department

Paris, 75019, France

NOT YET RECRUITING

Rennes University Hospital, Pediatric department

Rennes, 35000, France

NOT YET RECRUITING

Central Study Contacts

Patrick Van Bogaert, Professor

CONTACT

+33 2 41 35 48 46; Patrick.VanBogaert@chu-angers.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 22, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): November 15, 2026
• Study Completion (Estimated): November 15, 2026
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (9)