ClinicalTrials.gg
RecruitingNCT06059157EPIVAMUpdated Jun 15, 2026

Epileptogenic Network Visualisation With Advanced MRI

An interventional study of Advanced MRI in Drug Resistant Epilepsy, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 3 Years and older. Per ClinicalTrials.gov, last updated 2026-06-15.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Oct 2023; still recruiting 3 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
3 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 17 studies in Drug Resistant Epilepsy with a site in Belgium — 5 open to participants now, 6 under way, 1 of them phase 3. Drug Resistant Epilepsy · Belgium.

Planned enrollment
7th of 15
80 · median 40
Started
2023
with 1 other
No phase
8 of 17
4 open now
Registered
12th of 17
by date
Lead sponsor
4 of 17
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Among the 17 studies in Drug Resistant Epilepsy with a site in Belgium, this one is the 7th largest by planned enrollment of the 15 interventional ones that give a count, is one of 2 that started in 2023, is one of 8 with no phase, and was the 12th registered.

Drug Resistant Epilepsy

257 studies on the registry are indexed under Drug Resistant Epilepsy; 108 are open to participants now.

Browse Drug Resistant Epilepsy studies →

Open to participants now

5 of the 17 studies in Drug Resistant Epilepsy with a site in Belgium are open now. Recruiting first, the newest first:

All 5 open studies →

A study can be open while its sites in Belgium have not opened yet or have stopped. Only those recruiting at a site in Belgium →

Who these studies take

Of the 66 Drug Resistant Epilepsy studies recruiting now, 26 (39%) set no upper age limit and 39 (59%) stop at 75 or younger; 25 take children under 18; 6 take healthy volunteers.

This study: 3 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 17 studies in Drug Resistant Epilepsy with a site in Belgium, or all of them as a file.
02

Study 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.

Read the 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.

03

Conditions studied

  • Drug Resistant Epilepsy

Keywords

  • epilepsy
  • network
  • non-invasive investigation
04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient excluded from SEEG (pregnant women, children too young for the procedure, patient unable to undergo the procedure)
  • for MRI
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Single Arm

    Single Arm

    Device: Advanced MRI

Interventions

  • DeviceAdvanced MRI

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

06

What researchers measure

Primary outcomes

  1. 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 %.

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

  2. 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

    Time frame: One year after surgery (phase 2)

  3. 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)

    Time frame: Approximately 1 year after the start of phase 3

Secondary outcomes

  1. 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)

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

  2. 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)

    Time frame: One year after surgery (phase 2)

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Data will be kept on RedCap and made available after reasonable request

Supporting information: Study protocol, Statistical analysis plan

Time frame: 12 months after completion of the study

Access criteria: reasonable request evaluated by the research team

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2023 (actual). Primary completion is estimated for Oct 2026, 36 months after the start.

Of 90 non-industry interventional studies with no phase under Drug Resistant Epilepsy, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 21. This study's planned 36 months is close to that.

Counting every sponsor, half of 102 studies reached it within 34 months; a quarter within 21 and three quarters within 50.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2023
First posted
Sep 28, 2023
StartActual
Oct 25, 2023
Primary completionEst.
Oct 2026
CompletionEst.
Oct 2029
Last update
Jun 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06059157
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Oct 25, 2023
Primary completion
Oct 2026 (estimated)
Completion
Oct 2029 (estimated)
Last update
Jun 15, 2026

Study contacts

Riëm El Tahry, PhD
Contact
riem.eltahry@saintluc.uclouvain.be
003227641080
Riëm El Tahry, PhD
principal investigator · Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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