Clinical trial NCT06202976: Mapping Epileptic Networks Using Multimodal Imaging
Official title: Mapping Epileptic Networks Using Multimodal Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy in Children
Keywords: Focal Epilepsy
Lesional Epilepsy
Nonlesional Epilepsy
Lead sponsor: Imagine Institute
Sponsor class: OTHER
First posted: 2024-01-12
Enrollment: 75
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with refractory focal epilepsy, possibly due to lesions

Brief summary: 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.


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.

Primary outcomes:
measure: 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.
timeFrame: 15 years
Secondary outcomes:
measure: Study the pathophysiology of resistant lesional epilepsies
timeFrame: 15 years
measure: Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI
timeFrame: 15 years
measure: Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI.
timeFrame: 15 years
measure: Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities.
timeFrame: 15 years
measure: 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.
timeFrame: 15 years
measure: 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.
timeFrame: 15 years
measure: Improving understanding of the pathophysiology of rare non-lesional epilepsies
timeFrame: 15 years
Other outcomes:
Locations:
city: Paris
country: France
facility: Necker - Enfants Malades Hospital
Study officials:
References: