Epileptogenic Network Visualisation With Advanced MRI

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3+
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient suffering from drug-resistant epilepsy

Patient already selected for SEEG implantation as part of their epileptic networks

Disqualifiers

Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)

Contra-indication for MRI

Trial design

Design model

Single group

Treatments tested in this trial

  • Advanced MRI

    Device

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

Treatment groups

80 Participants
are divided into 1 treatment group
Group A: Single ArmExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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 %.

Time frame
At the end of phase 1 - expected to be 3 years after first inclusion
2

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

Time frame
One year after surgery (phase 2)
3

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)

Time frame
Approximately 1 year after the start of phase 3

Secondary outcomes

1

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)

Time frame
At the end of phase 1 - expected to be 3 years after first inclusion
2

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)

Time frame
One year after surgery (phase 2)

Other outcomes

Sponsors and contacts

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