Clinical trial NCT06059157: Epileptogenic Network Visualisation With Advanced MRI
Official title: Epileptogenic Network Visualisation With Advanced MRI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Drug Resistant Epilepsy
Keywords: epilepsy
network
non-invasive investigation
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to improve non-invasive identification of epileptogenic networks in drug-resistant epileptic patient.

The investigators aim to compare epileptogenic network identification with stereo-EEG (used as glod standard) with the identification of the same network using advanced MRI (rs-fMRI, microstructural analysis of white matter, ...). The main goals are to:

1. Compare the accuracy of network identification.
2. Analyse the effect of the MRI sequences on candidates selection and target identification.

Participants will already have been selected for stereoEEG and will undergo a supplementary MRI (about 1h) with the additional MRI sequences. Follow-up MRI are scheduled for patient undergoing a second, therapeutic epileptic surgery.

Detailed description: Patient identified for SEEG will undergo, prior to the implantation procedure an MRI with the following sequences:

* 3D T1
* rsfMRI
* multishell diffusion

The rsfMRI will be post-processed to delineate the epileptogenic networks based on an Independant Component Analysis (ICA) methods. Once the epileptogenic network(s) has/have been identified, connexion between the different regions will be identified through post-processing of the diffusion using a MSMT-CSD algorithm. Finally, the identified tract between the different region will be quantitatively analysed using different algorithms (NODDI, DIAMOND, MF) to better grasp there integrity.

In a follow-up study, the patients that will later on benefit from a resection or disconnection (i.e. curative surgery) will also have an identical MRI 3 months after the said procedure to evaluate the evolution on the network(s) based on the same criteria.

Eligibility criteria: Inclusion Criteria:

* Patient suffering from drug-resistant epilepsy
* Patient already selected for SEEG implantation as part of their epileptic networks

Exclusion Criteria:

* Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)
* Contra-indication for MRI

Primary outcomes:
measure: Network identification with MRI
timeFrame: At the end of phase 1 - expected to be 3 years after first inclusion
measure: Prognosis of network targetting with surgery
timeFrame: One year after surgery (phase 2)
measure: Interest of adding epileptic network radiological analysis in a standard epileptic work-up
timeFrame: Approximately 1 year after the start of phase 3
Secondary outcomes:
measure: Network quantification
timeFrame: At the end of phase 1 - expected to be 3 years after first inclusion
measure: Network regulation with surgery
timeFrame: One year after surgery (phase 2)
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques Universitaires St-Luc
Study officials:
affiliation: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
name: Riëm El Tahry, PhD
role: PRINCIPAL_INVESTIGATOR
References: