Epileptogenic Network Visualisation With Advanced MRI

NCT ID: NCT06059157

Last Updated: 2024-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-25

Study Completion Date

2029-10-31

Brief Summary

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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

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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.

Conditions

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Drug Resistant Epilepsy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

Single Arm

Group Type EXPERIMENTAL

Advanced MRI

Intervention Type DEVICE

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

Interventions

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Advanced MRI

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Riëm El Tahry, PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Locations

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Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Riëm El Tahry, PhD

Role: CONTACT

003227641080

Facility Contacts

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Riëm El Tahry, PhD

Role: primary

+3227642855

Vincent Joris, MD

Role: backup

+3227641085

Other Identifiers

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2023/26JUI/281

Identifier Type: -

Identifier Source: org_study_id

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