Epileptogenic Network Visualisation With Advanced MRI

Not Applicable

Recruiting

• Conditions: Drug Resistant Epilepsy
• Interventions: Device: Advanced MRI

• Registration Number: NCT06059157
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2023-09-06
• Study First Submitted QC: 2023-09-22
• Study First Posted: 2023-09-28
• Study Start: 2023-10-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-14
• Last Update Posted: 2024-03-18
• Primary Completion: 2026-10
• Study Completion: 2029-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	Advanced MRI	Single Arm

Primary Outcome Measures

Name	Time	Method
Interest of adding epileptic network radiological analysis in a standard epileptic work-up	Approximately 1 year after the start of phase 3	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)
Network identification with MRI	At the end of phase 1 - expected to be 3 years after first inclusion	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 %.
Prognosis of network targetting with surgery	One year after surgery (phase 2)	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

Secondary Outcome Measures

Name	Time	Method
Network regulation with surgery	One year after surgery (phase 2)	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)
Network quantification	At the end of phase 1 - expected to be 3 years after first inclusion	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)

Trial Locations

Locations (1)

Cliniques Universitaires St-Luc; 🇧🇪 Brussel, Belgium