Epileptogenic Network Visualisation With Advanced MRI

NCT06059157 | Recruiting DMC

• 1 other identifier: 2023/26JUI/281
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Compare the accuracy of network identification.
2. 2.Analyse the effect of the MRI sequences on candidates selection and target identification.

Conditions

Drug Resistant Epilepsy

Keywords

epilepsy; network; non-invasive investigation

Outcome Measures

Primary Outcomes (3)

• 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 %.

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

• 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

  One year after surgery (phase 2)

• 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)

  Approximately 1 year after the start of phase 3

Secondary Outcomes (2)

• Network quantification

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

• Network regulation with surgery

  One year after surgery (phase 2)

Study Arms (1)

Single Arm

EXPERIMENTAL

Single Arm

Device: Advanced MRI

Interventions

Advanced MRI DEVICE

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

Single Arm

Eligibility Criteria

• Age: 3 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient suffering from drug-resistant epilepsy
• Patient already selected for SEEG implantation as part of their epileptic networks

You may not qualify if:

• Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)
• Contra-indication for MRI

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

RECRUITING

MeSH Terms

Conditions

Drug Resistant Epilepsy; Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Riëm El Tahry, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Riëm El Tahry, PhD

CONTACT

003227641080; riem.eltahry@saintluc.uclouvain.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 28, 2023
• Study Start: October 25, 2023
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 18, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: 12 months after completion of the study
• Access Criteria: reasonable request evaluated by the research team

Locations

BE (1)