Mapping Epileptic Networks Using Multimodal Imaging

Epilepsy in Children Clinical Trial

— CREIM  

Official title:

Mapping Epileptic Networks Using Multimodal Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202976
• Other study ID #: IM-RCM-2017-02
• Status: Recruiting
• Start date: September 14, 2017
• Est. completion date: September 13, 2030

Study information

• Verified date: January 2024
• Source: Imagine Institute
• Contact: Nathalie Boddaert, Pr
• Phone: +33 (0)1 44 49 51 75
• Email: nathalie.boddaert[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 13, 2030
• Est. primary completion date: September 13, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy in Children

Intervention

Other:
• Secondary data collection
clinical data

Locations

Country	Name	City	State
France	Necker - Enfants Malades Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imagine Institute

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI		15 years
Secondary	Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI.		15 years
Secondary	Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities.		15 years
Secondary	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
Secondary	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
Secondary	Improving understanding of the pathophysiology of rare non-lesional epilepsies		15 years