Actively Recruiting

Phase Not Applicable
Age: 2Years - 17Years
All Genders
NCT06271785

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

Led by University Hospital, Angers · Updated on 2025-09-19

120

Participants Needed

9

Research Sites

130 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 2Years - 17Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 2 to less than 17 years
  • Drug-resistant focal epilepsy with failure of at least 2 well-conducted drug trials
  • Phase 1 preoperative evaluation with scalp video-EEG, MRI, and PET-FDG suggesting suitability for epilepsy surgery
  • Recent scalp EEG within 12 months showing interictal spikes
  • High-quality, recent (within 6 months) structural MRI with 3D-T1 sequences covering whole brain and scalp available
Not Eligible

You will not qualify if you...

  • Behavioral deficits preventing scalp EEG recording without sedation
  • Informed consent form not signed by parents
  • Patient not affiliated with a social security system

AI-Screening

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Trial Site Locations

Total: 9 locations

1

Angers university hospital, Pédiatric department

Angers, France, 49000

Actively Recruiting

2

Lille University Hospital, Clinical Neurophysiology Department

Lille, France, 59000

Not Yet Recruiting

3

Civil Hospices of Lyon, Functional Neurology Department

Lyon, France, 69677

Not Yet Recruiting

4

Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department

Marseille, France, 13000

Not Yet Recruiting

5

Nancy University Hospital, Neurology Department

Nancy, France, 54000

Not Yet Recruiting

6

Paris Neck University Hospital, Pediatric department

Paris, France, 75015

Not Yet Recruiting

7

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

Paris, France, 75019

Not Yet Recruiting

8

Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department

Paris, France, 75019

Not Yet Recruiting

9

Rennes University Hospital, Pediatric department

Rennes, France, 35000

Not Yet Recruiting

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Research Team

P

Patrick Van Bogaert, Professor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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