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Clinical Trials/NCT06202976
NCT06202976
Recruiting
Not Applicable

Mapping Epileptic Networks Using Multimodal Imaging

Imagine Institute1 site in 1 country75 target enrollmentSeptember 14, 2017

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epilepsy in Children
Sponsor
Imagine Institute
Enrollment
75
Locations
1
Primary Endpoint
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.
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 14, 2017
End Date
September 13, 2033
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
Imagine Institute
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

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.

Time Frame: 15 years

Secondary Outcomes

  • 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)
  • Improving understanding of the pathophysiology of rare non-lesional epilepsies(15 years)
  • Study the pathophysiology of resistant lesional epilepsies(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)

Study Sites (1)

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