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Epileptogenic Network Visualisation With Advanced MRI (EPIVAM)

Primary Purpose

Drug Resistant Epilepsy

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Advanced MRI
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Drug Resistant Epilepsy focused on measuring epilepsy, network, non-invasive investigation

Eligibility Criteria

3 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Single Arm

    Arm Description

    Single Arm

    Outcomes

    Primary Outcome Measures

    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 %.
    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
    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)

    Secondary Outcome Measures

    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)
    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)

    Full Information

    First Posted
    September 6, 2023
    Last Updated
    September 22, 2023
    Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06059157
    Brief Title
    Epileptogenic Network Visualisation With Advanced MRI
    Acronym
    EPIVAM
    Official Title
    Epileptogenic Network Visualisation With Advanced MRI
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2026 (Anticipated)
    Study Completion Date
    October 2029 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: Compare the accuracy of network identification. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Drug Resistant Epilepsy
    Keywords
    epilepsy, network, non-invasive investigation

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Single Arm
    Arm Type
    Experimental
    Arm Description
    Single Arm
    Intervention Type
    Device
    Intervention Name(s)
    Advanced MRI
    Intervention Description
    resting-state functional MRI, diffusion with advanced post-processing (microstructure analysis), myelin mapping
    Primary Outcome Measure Information:
    Title
    Network identification with MRI
    Description
    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
    Title
    Prognosis of network targetting with surgery
    Description
    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)
    Title
    Interest of adding epileptic network radiological analysis in a standard epileptic work-up
    Description
    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 Outcome Measure Information:
    Title
    Network quantification
    Description
    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
    Title
    Network regulation with surgery
    Description
    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)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    No
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Riëm El Tahry, PhD
    Phone
    003227641080
    Email
    riem.eltahry@saintluc.uclouvain.be
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Riëm El Tahry, PhD
    Organizational Affiliation
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Data will be kept on RedCap and made available after reasonable request

    Learn more about this trial

    Epileptogenic Network Visualisation With Advanced MRI

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