Mapping Epileptic Networks Using Multimodal Imaging

NCT06202976 | Recruiting

• 1 other identifier: IM-RCM-2017-02
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy in Children

Keywords

Focal Epilepsy; Lesional Epilepsy; Nonlesional Epilepsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Study the pathophysiology of resistant lesional epilepsies

  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

Study Arms (1)

Patients

Other: Secondary data collection

Interventions

Secondary data collection OTHER

clinical data

Patients

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Children with refractory focal epilepsy, possibly due to lesions

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Imagine Institute: lead

Study Sites (1)

Necker - Enfants Malades Hospital

Paris, 75015, France

RECRUITING

MeSH Terms

Conditions

Epilepsies, Partial

Condition Hierarchy (Ancestors)

Epilepsy; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Nathalie Boddaert, Pr

CONTACT

+33 (0)1 44 49 51 75; nathalie.boddaert@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: September 14, 2017
• Primary Completion (Estimated): September 13, 2033
• Study Completion (Estimated): September 13, 2033
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)