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NCT Number: NCT06202976

Mapping Epileptic Networks Using Multimodal Imaging

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.

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Key information

Conditions

Epilepsy in Children Brain Diseases Central Nervous System Diseases Epilepsies, Partial Epilepsy Nervous System Diseases

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secondary data collection

Other

clinical data

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.

    Time frame: 15 years

Secondary outcomes

  1. Study the pathophysiology of resistant lesional epilepsies

    Time frame: 15 years

    Measurements of perfusion in ASL-MRI (inter and/or percritical) and the BOLD effect in resting-state fMRI

  2. Correlate cortical perfusion change on SL-ASMRI and BOLD signal abnormalities on resting-state fMRI

    Time frame: 15 years

  3. Compare cortical perfusion abnormalities and resting-state fMRI based on EEG data in MRI.

    Time frame: 15 years

  4. Correlate BOLD-MRI perfusion abnormalities with anatomical (DTI (tractography)) and functional (resting-state fMRI) brain connectivity abnormalities.

    Time frame: 15 years

  5. 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.

    Time frame: 15 years

  6. 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.

    Time frame: 15 years

  7. Improving understanding of the pathophysiology of rare non-lesional epilepsies

    Time frame: 15 years

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie Boddaert, Pr

CONTACT

[email protected]

+33 (0)1 44 49 51 75

Sponsors and collaborators

Lead sponsor

Imagine Institute

Other

Registry information

Acronym: CREIM

Important dates

Study start
2017
Primary completion
2033
Study completion
2033
First posted
Jan 12, 2024
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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