NCT Number: NCT06059157
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.
Interested in participating?
Request Info3 year and older
All sexes
Interventional
Not applicable
Brussels, 1200, Belgium
Location status: Recruiting
Alexane Fierain, MD
SUB_INVESTIGATOR
Riëm El Tahry, PhD
CONTACT
Riëm El Tahry, PhD
PRINCIPAL_INVESTIGATOR
Susana Ferrao-Santos, PhD
SUB_INVESTIGATOR
Vincent Joris, MD
CONTACT
Vincent Joris, MD
SUB_INVESTIGATOR
Patient identified for SEEG will undergo, prior to the implantation procedure an MRI with the following sequences:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
resting-state functional MRI, diffusion with advanced post-processing (microstructure analysis), myelin mapping
Time frame: 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 %.
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Other
Acronym: EPIVAM
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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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