Epileptogenic Network Visualisation With Advanced MRI

Drug Resistant Epilepsy Clinical Trial

— EPIVAM  

Official title:

Epileptogenic Network Visualisation With Advanced MRI

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06059157
• Other study ID #: 2023/26JUI/281
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: October 2029

Study information

• Verified date: March 2024
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: Riëm El Tahry, PhD
• Phone: 003227641080
• Email: riem.eltahry[@]saintluc.uclouvain.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: October 2029
• Est. primary completion date: October 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Drug Resistant Epilepsy
• Epilepsy

Intervention

Device:
• Advanced MRI
resting-state functional MRI, diffusion with advanced post-processing (microstructure analysis), myelin mapping

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St-Luc	Brussel

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)
Primary	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	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
Secondary	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)