Mapping Epileptic Networks Using Multimodal Imaging (CREIM)

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy in Children
• Intervention / Treatment: Other: Secondary data collection

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Nathalie Boddaert, Pr; Phone Number: +33 (0)1 44 49 51 75; Email: nathalie.boddaert@aphp.fr

Study Locations

• France
  • Paris, France, 75015
    • Recruiting
    • Necker - Enfants Malades Hospital
    • Contact: Nathalie Boddaert, Pr; Phone Number: +33 (0)1 44 49 51 75; Email: nathalie.boddaert@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with refractory focal epilepsy, possibly due to lesions

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients	Other: Secondary data collection; clinical data

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.	15 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Study the pathophysiology of resistant lesional epilepsies	Measurements of perfusion in ASL-MRI (inter and/or percritical) and the BOLD effect in resting-state fMRI	15 years
Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI		15 years
Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI.		15 years
Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities.		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.		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.		15 years
Improving understanding of the pathophysiology of rare non-lesional epilepsies		15 years

Collaborators and Investigators

• Sponsor: Imagine Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2017
• Primary Completion (Estimated): September 13, 2033
• Study Completion (Estimated): September 13, 2033

Study Registration Dates

• First Submitted: January 2, 2024
• First Submitted That Met QC Criteria: January 2, 2024
• First Posted (Actual): January 12, 2024

Study Record Updates

• Last Update Posted (Actual): April 17, 2025
• Last Update Submitted That Met QC Criteria: April 14, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Focal Epilepsy; Lesional Epilepsy; Nonlesional Epilepsy
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: IM-RCM-2017-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No