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Epileptogenic Network Visualisation With Advanced MRI (EPIVAM)

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ClinicalTrials.gov Identifier: NCT06059157
Recruitment Status : Recruiting
First Posted : September 28, 2023
Last Update Posted : March 18, 2024
Sponsor:
Information provided by (Responsible Party):
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Description
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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.


Condition or disease Intervention/treatment Phase
Drug Resistant Epilepsy Device: Advanced MRI Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Epileptogenic Network Visualisation With Advanced MRI
Actual Study Start Date : October 25, 2023
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : October 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arms and Interventions
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Arm Intervention/treatment
Experimental: Single Arm
Single Arm
 Device: Advanced MRI
resting-state functional MRI, diffusion with advanced post-processing (microstructure analysis), myelin mapping


Outcome Measures
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Primary Outcome Measures :
  1. Network identification with MRI [ 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 %.

  2. Prognosis of network targetting with surgery [ 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

  3. Interest of adding epileptic network radiological analysis in a standard epileptic work-up [ 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)


Secondary Outcome Measures :
  1. Network quantification [ 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)

  2. Network regulation with surgery [ 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)


Eligibility Criteria
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Ages Eligible for Study:   3 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06059157


Contacts
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Contact: Riëm El Tahry, PhD 003227641080 riem.eltahry@saintluc.uclouvain.be

Locations
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Belgium
Cliniques Universitaires St-Luc Recruiting
Brussel, Belgium, 1200
Contact: Riëm El Tahry, PhD    +3227642855    riem.eltahry@saintluc.uclouvain.be   
Contact: Vincent Joris, MD    +3227641085    vincent.j.joris@saintluc.uclouvain.be   
Principal Investigator: Riëm El Tahry, PhD         
Sub-Investigator: Vincent Joris, MD         
Sub-Investigator: Susana Ferrao-Santos, PhD         
Sub-Investigator: Alexane Fierain, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
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Principal Investigator: Riëm El Tahry, PhD Cliniques universitaires Saint-Luc- Université Catholique de Louvain
More Information
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Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier: NCT06059157    
Other Study ID Numbers: 2023/26JUI/281
First Posted: September 28, 2023    Key Record Dates
Last Update Posted: March 18, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be kept on RedCap and made available after reasonable request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: 12 months after completion of the study
Access Criteria: reasonable request evaluated by the research team

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain:
epilepsy
network
non-invasive investigation
Additional relevant MeSH terms:
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Epilepsy
Drug Resistant Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases