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Recruiting NCT06202976

Mapping Epileptic Networks Using Multimodal Imaging

— Observational Epilepsy in Children

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Secondary data collection.
Who it may be relevant to
Registry conditions: Epilepsy in Children. Basic parameters: up to 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Currently, mapping the epileptogenic zone is based on a comprehensive preoperative assessment involving clinical, imaging and electrophysiological examinations. To reduce the need for invasive stereoelectroencephalography (SEEG) explorations, electrophysiological and imaging methods have been developed, such as resting-state functional MRI (fMRI) coupled with electroencephalogram and arterial spin-labeling perfusion MRI (ASL-MRI). It has been published that these new methods enable precise delineation of the epileptogenic zone and better preparation for surgery. The aim is to determine whether, in children with focal lesional epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG enables precise identification of the epileptogenic zone to be defined by SEEG, the current reference examination.

Interventions

  • Other Secondary data collection
    clinical data

Primary outcome measures

  • Determine whether, in children with lesional focal epilepsy, the combination of ASL-MRI-EEG and resting-state fMRI-EEG can accurately identify the epileptogenic zone to be defined by SEEG, today's gold standard. [Time frame: 15 years]
Secondary outcome measures (7)
  • Study the pathophysiology of resistant lesional epilepsies [Time frame: 15 years]
  • Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI [Time frame: 15 years]
  • Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI. [Time frame: 15 years]
  • Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities. [Time frame: 15 years]
  • Compare ASL-MRI and resting-state fMRI data coupled with EEG to the results of deep electrodes (intracranial EEG - SEEG), which are today's gold standard. [Time frame: 15 years]
  • Evaluate whether these data will eventually make it possible to reduce the frequency of intracranial EEG explorations (stereo EEG, subdural grids), with a view to replacing invasive deep electrodes in the future with multimodal MRI coupled to EEG in MRI. [Time frame: 15 years]
  • Improving understanding of the pathophysiology of rare non-lesional epilepsies [Time frame: 15 years]

Eligibility criteria

Inclusion criteria

  • Be under 18 years of age on the day of inclusion.
  • Present with one of the following forms of epilepsy:
  • refractory focal lesional epilepsy
  • rare non-lesional epilepsy
  • Present abnormalities (spikes) on the intercritical EEG
  • Have been selected by the "Epilepsy" multidisciplinary staff.
  • In the case of refractory lesional epilepsy, be required to perform an EEG-video recording using intracranial electrodes (SEEG) as part of the pre-surgical workup.
  • Be affiliated to a health insurance scheme.

Exclusion criteria

  • Requiring general anesthesia for MRI
  • Require sedation specifically for research
  • Have generalized epilepsy
  • Be deprived of liberty or under guardianship.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Necker - Enfants Malades Hospital — Paris

Identifiers

NCT: NCT06202976 · IM-RCM-2017-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗