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Epilepsy in ChildrenISEPEENCT06271785

Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery

A study testing HR-EEG recording in people with Epilepsy in Children, run by University Hospital, Angers at 9 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children. Read more about this study

Who is it for?
Ages 2 to 17 years
Conditions the study is for
Epilepsy in Children
What is being tested?
HR-EEG recording
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
9 sitesFrance
Study dates
15 May 2024to 15 Nov 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age≥2 and <17 years;
  • Drug-resistant focal epilepsy (failure of at least 2 well-conducted drug trials);
  • Phase 1 pre-op evaluation with scalp video-EEG recording, MRI and PET-FDG suggesting that the patient could be a good candidate for epilepsy surgery;
  • Recent scalp EEG record (within 12 months) showing the presence of interictal spikes;
  • High-quality and recent (within 6 months) structural MRI with 3D-T1 sequences covering the whole brain and the scalp available.

Who cannot join

  • Behavioral deficits making recording of scalp EEG impossible without sedation;
  • Informed consent form not signed by the parents;
  • Patient not affiliated to a social security system

Trial locations and contacts

9 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Patrick Van Bogaert, Professor contact

+33 2 41 35 48 46

Patrick.VanBogaert@chu-angers.fr

9 sites in 1 country

France9 sites, 9 recruiting
  • Angers university hospital, Pédiatric department

    Angers, 49000

    Patrick Van Bogaert, Professor, 02 41 35 48 46, Patrick.VanBogaert@chu-angers.fr

    Recruiting
  • Lille University Hospital, Clinical Neurophysiology Department

    Lille, 59000

    Philippe DERAMBURE, Professor, 03 20 44 63 62, Philippe.DERAMBURE@CHRU-LILLE.FR

    Not yet recruiting
  • Civil Hospices of Lyon, Functional Neurology Department

    Lyon, 69677

    Julien Jung, Doctor, 04 72 35 79 00, julien.jung@chu-lyon.fr

    Not yet recruiting
  • Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department

    Marseille, 13000

    Fabrice BARTOLOMEI, Professor, 04 91 38 46 84, Fabrice.BARTOLOMEI@ap-hm.fr

    Not yet recruiting
  • Nancy University Hospital, Neurology Department

    Nancy, 54000

    Louis Maillard, Professor, 03 83 85 16 09, l.maillard@chru-nancy.fr

    Not yet recruiting
  • Paris Neck University Hospital, Pediatric department

    Paris, 75015

    Anna Kaminska, Doctor, 01 44 49 51 85, anna.kaminska@aphp.fr

    Not yet recruiting
  • Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations

    Paris, 75019

    François-Xavier MAUVAIS, Doctor, 01 40 03 20 00, francois-xavier.mauvais@aphp.fr

    Not yet recruiting
  • Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department

    Paris, 75019

    Emmanuel Raffo, Professor, 01 48 03 68 17, eraffo@for.paris

    Not yet recruiting
  • Rennes University Hospital, Pediatric department

    Rennes, 35000

    Silvia Adriana NAPURI PEIRANO, Doctor, 02 99 26 58 34, Silviaadriana.NAPURI.PEIRANO@chu-rennes.fr

    Not yet recruiting

Other trials in France

About this study

Official title: ISEPEE : Prognostic Value of High-resolution Electrical Source Imaging on the Success of Pediatric Focal Epilepsy Surgery

This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.

This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.

Read more

Electrical sources are then fused on structural magnetic resonance imaging (MRI).

Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.

Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.

Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.

Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.

Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.

To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.

This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.

The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.

Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.

Read the detailed description

This study investigates the usefulness of high resolution electrical source imaging (HR-ESI) in the setting of presurgical evaluation of drug-resistant focal epilepsy in children.

This method is based on an estimation of the intra-cerebral source that produces a signal recorded by scalp electrodes by solving the inverse problem, taking into account attenuation factors resulting from particular conductivity properties of the cerebral, peri-cerebral and cranial tissues.

Electrical sources are then fused on structural magnetic resonance imaging (MRI).

Scalp EEG recorded using 64 to 256 electrodes refers to as high resolution EEG (HR-EEG), leading to HR-ESI.

Studies based on small population of children or on mixt population of children and adults showed that HR-ESI has accuracy values, i.e. percentage of true positives (electrical source localized in the brain area resected and success of surgery) and true negatives (electrical source localized outside the brain area resected and failure of surgery) among the total population, ranging from 50 to 80%.

Discrepancies between studies could be explained by the limited number of patients included or by the mixture of pediatric and adult data.

Another limitation of previously published studies is that the spatial pattern of dipole source distribution was not taken into account to determine prediction accuracy of ESI.

Studies using magnetoencephalography (MEG) to perform magnetic source imaging (MSI) suggest that the spatial pattern of dipole source distribution needs to be considered, a spatially-restricted dipole distribution being associated with better post-surgical outcome when resected.

To tackle these issues, the investigators aim to conduct the first large prospective multicentric study in children with focal epilepsy candidates to surgery to assess prediction accuracy of ESI based on the finding of tight clusters of dipoles.

This is original as this pattern (tight versus loose cluster of dipoles) has been studied by several researchers using MEG but not using HR-EEG.

The investigators make the hypothesis that HR-EEG will allow to identity good candidates for epilepsy surgery and thus to offer this underutilized treatment in more children with better post-surgical outcome.

Among the secondary objectives, the investigators will address methodological issues related to the resolution of the inverse problem (methods using distributed sources models versus methods based on equivalent dipole estimation), the potential added value to model high-frequency oscillations (HFO), and the investigators will assess the cost-utility of the HR-ESI procedure.

The study focuses on epileptic children who are candidates to a procedure of epilepsy surgery aiming to make them seizure-free. The principle of epilepsy surgery is to remove the brain area that generates patient's seizures, i.e. the seizure onset zone (SOZ). Candidates are patients with focal seizures that do not completely respond to the medical treatment and impact their quality of life. This represents 5-10% of epileptic children. Pre-surgical evaluation of these patients consists to perform in a first step non-invasive methods aimed to localize the SOZ: video-EEG in order to characterize usual seizures of the patient and to record and localize interictal epileptiform discharges (IED), MRI to search for a structural epileptogenic lesion, and positron emission tomography (PET) with fluorodeoxyglucose (FDG) to search for a brain area showing abnormal FDG uptake. After this so-called phase 1 work-up, the case is discussed in a multidisciplinary meeting, resulting in one of the 3 following decisions: (1) surgical resection when information from phase 1 is considered as sufficient, (2) continuation of the surgical process by performing a phase 2 evaluation, i.e. an invasive EEG recording using intracranial electrodes implanted by stereotaxy (SEEG), when information from phase 1 is considered as insufficient but made possible to pose a hypothesis regarding the localization of the SOZ, and (3) rejection for surgery. In children, epilepsy makes patient seizure-free in 60-80% of the cases. HR-ESI is a relatively new method that has been developed to localize non-invasively the SOZ with the hope to decrease the number of patients rejected for surgery or oriented to phase 2, and to increase the rate of success of epilepsy surgery.

Being tested
HR-EEG recording

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HR-EEG recordingDiagnostic test

    All participants will have a HR-EEG recordings. It will be made at rest. Nap-like sleep is encouraged, but no sedatives will be given. Recording time will not exceed two hours.

Study groups in NCT06271785
Study groupRoleWhat they receive
HR-EEG recordingExperimentalNot described
Receives: Diagnostic Test: HR-EEG recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prediction accuracy index

    The main outcome is the prediction accuracy index, as assessed in fusing pre-op current equivalent dipoles to postop MRI, based on a tight cluster of spikes compared to the prediction accuracy index based on a loose cluster of spikes or on multiple clusters of spikes.

    Measured: 24 months

Secondary outcomes (6)
  1. Localization of the epileptogenic zone (Baseline)

    To assess the ability of HR-ESI to localize the epileptogenic zone. Spatial congruence between the brain areas involved by the sources of interictal spikes and the epileptogenic zone, defined by either a MRI lesion concordant with the electroclinical data, or the brain area resected in patients who achieved good outcome following surgery.

    Measured: Baseline

  2. Localization of the epileptogenic zone (After Surgery)

    To assess the ability of HR-ESI to localize the epileptogenic zone. Spatial congruence between the brain areas involved by the sources of interictal spikes and the epileptogenic zone, defined by either a MRI lesion concordant with the electroclinical data, or the brain area resected in patients who achieved good outcome following surgery.

    Measured: 24 months (= V3)

  3. preoperative accuracy of epileptogenic source localization

    To determine the preoperative accuracy of epileptogenic source localization delineated by HR-ESI.

    Spatial congruence between the brain areas involved by the sources of interictal spikes and the SOZ as assessed by intracranial EEG in patients oriented to intracranial EEG investigation.

    Measured: 12 months (= V2)

  4. prognostic value of HFO

    To determine the prognostic value of epileptogenic source localization delineated by HR-ESI based on high-frequency oscillations (HFO), on successful epilepsy surgery.

    Prediction accuracy index, as assessed in fusing pre-op current equivalent dipoles to postop MRI, based on of a unique, well delineated and completely resected cluster of HFO, compared to other situations.

    Measured: 24 months (= V3)

  5. Impact of method of sources reconstruction, conditions of EEG recordings and sampling rate

    To study the influence of some factors that could impact results of HR-ESI: type of method of sources reconstruction, conditions of EEG recordings (awake state versus sleep), and sampling rate.

    Congruence of the brain areas identified by HR-ESI according to the methods of sources reconstruction, the type of spikes (awake versus sleep) and the sampling rate.

    Measured: 3 months (= V1)

  6. health-economic modeling

    To perform a health-economic modeling to assess cost-utility and cost-effectiveness of the HR-ESI procedure. Evolution of Quality of life assessed with Child Health Utility 9 Dimensions (CHU9D) questionnaire

    Measured: 24 months (= V3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start15 May 2024
  3. Primary completion15 Nov 2026 (estimated)
  4. Study completion15 Nov 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271785
Sponsor's protocol ID
49RC22_0354
Acronym
ISEPEE
Status last verified
Sep 2025
First submitted
14 Feb 2024
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing HR-EEG recording in people with Epilepsy in Children, run by University Hospital, Angers at 9 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Patrick Van Bogaert, Professor (+33 2 41 35 48 46, Patrick.VanBogaert@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prediction accuracy index (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2025.

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