Epileptogenic Network Visualisation With Advanced MRI (EPIVAM)

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.

Study Overview

• Status: Recruiting
• Conditions: Drug Resistant Epilepsy
• Intervention / Treatment: Device: Advanced MRI

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Riëm El Tahry, PhD; Phone Number: 003227641080; Email: riem.eltahry@saintluc.uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires St-Luc
    • Contact: Riëm El Tahry, PhD; Phone Number: +3227642855; Email: riem.eltahry@saintluc.uclouvain.be
    • Contact: Vincent Joris, MD; Phone Number: +3227641085; Email: vincent.j.joris@saintluc.uclouvain.be
    • Principal Investigator: Riëm El Tahry, PhD
    • Sub-Investigator: Vincent Joris, MD
    • Sub-Investigator: Susana Ferrao-Santos, PhD
    • Sub-Investigator: Alexane Fierain, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Single Arm	Device: Advanced MRI; resting-state functional MRI, diffusion with advanced post-processing (microstructure analysis), myelin mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Network identification with MRI	Analysis of the anatomical overlap of radiological network (with MRI) and the electrophysiological network (with SEEG) using coregistration and a sublobar analysis. Overlap will be quantified in %.	At the end of phase 1 - expected to be 3 years after first inclusion
Prognosis of network targetting with surgery	Analysis of the impact on epileptic outcome in accordance with effect of the surgery on the network. The impact of the surgery on the network will be assessed by coregistration to determine which part of the network has been removed or disconnected. The epileptic outcome will be assessed using the Engel classification	One year after surgery (phase 2)
Interest of adding epileptic network radiological analysis in a standard epileptic work-up	Analyse the impact on therapeutic and/or diagnostic decision of the network radiological analysis in a standard clinical practice. This impact will be assessed by measuring the change in the type of decision (further work-up, invasive EEG, "curative" surgery, "palliative" surgery or no modification) or the modification in the extent of surgery (more/less electrodes for invasive EEG, more/less tissue targeted with surgery)	Approximately 1 year after the start of phase 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Network quantification	Analysis of the strength of the network using radiological data (r², Z-score, diffusion metrics obtained via microfingerprinting such as fiber volume fraction and fiber fraction) vs electrophysiological metrics (epileptogenic index, h²)	At the end of phase 1 - expected to be 3 years after first inclusion
Network regulation with surgery	Analysis of the impact of the surgery on the radiological parameters of the network cited in outcome 4 (r² and Z-score for rsfMRI, number of tracts for tractography and strenght of tract with fiber fraction and fiber volume fraction for microfingerprinting)	One year after surgery (phase 2)

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Investigators: Principal Investigator: Riëm El Tahry, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029

Study Registration Dates

• First Submitted: September 6, 2023
• First Submitted That Met QC Criteria: September 22, 2023
• First Posted (Actual): September 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 15, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: epilepsy; network; non-invasive investigation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Drug Resistant Epilepsy; Epilepsy
• Other Study ID Numbers: 2023/26JUI/281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be kept on RedCap and made available after reasonable request
• IPD Sharing Time Frame: 12 months after completion of the study
• IPD Sharing Access Criteria: reasonable request evaluated by the research team
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No