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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06202976
Other study ID # IM-RCM-2017-02
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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