EPIVAM: Epileptogenic Network Visualisation With Advanced MRI

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06059157
Collaborator
(none)
80
1
72

Study Details

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:

  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
  • Device: Advanced MRI
N/A

Study Design

Study Type:
Interventional
Anticipated 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
Anticipated Study Start Date :
Oct 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2026
Anticipated Study Completion Date :
Oct 1, 2029

Arms and Interventions

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

Primary Outcome Measures

  1. Network identification with MRI [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 [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 [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 [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 [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

Criteria

Ages Eligible for Study:
3 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

No locations specified.

Sponsors and Collaborators

  • Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Investigators

  • Principal Investigator: Riëm El Tahry, PhD, Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
ClinicalTrials.gov Identifier:
NCT06059157
Other Study ID Numbers:
  • 2023/26JUI/281
First Posted:
Sep 28, 2023
Last Update Posted:
Sep 28, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 28, 2023