Epileptogenic Network Visualisation With Advanced MRI
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Advanced MRI.
- Who it may be relevant to
- Registry conditions: Drug Resistant Epilepsy. Basic parameters: from 3 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Device Advanced MRI
resting-state functional MRI, diffusion with advanced post-processing (microstructure analysis), myelin mapping
Primary outcome measures
- Network identification with MRI [Time frame: At the end of phase 1 - expected to be 3 years after first inclusion]
- Prognosis of network targetting with surgery [Time frame: One year after surgery (phase 2)]
- Interest of adding epileptic network radiological analysis in a standard epileptic work-up [Time frame: Approximately 1 year after the start of phase 3]
Secondary outcome measures (2)
- Network quantification [Time frame: At the end of phase 1 - expected to be 3 years after first inclusion]
- Network regulation with surgery [Time frame: One year after surgery (phase 2)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Belgium · 1 center
- Cliniques Universitaires St-Luc — Brussels
Identifiers
NCT: NCT06059157 · 2023/26JUI/281