Evaluating high-resolution electrical imaging for epilepsy surgery in children

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

This study is testing if a new brain imaging technique can help doctors better plan surgery for children with epilepsy that doesn't respond to medication.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 2 Years to 17 Years
• Sex: All
• Sponsor: University Hospital, Angers (Government)
• Locations: 9 sites (Angers and 8 other locations)
• Trial ID: NCT06271785 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of high-resolution electrical source imaging (HR-ESI) in assessing children with drug-resistant focal epilepsy before surgery. The approach involves using scalp electrodes to estimate the brain's electrical sources and fusing this data with structural MRI images. By analyzing the accuracy of HR-ESI in predicting surgical outcomes, the study aims to improve the presurgical evaluation process for pediatric patients. The research focuses on children aged 2 to 17 who have not responded to at least two anti-epileptic drug trials.

Who should consider this trial

Good fit: Ideal candidates are children aged 2 to 17 with drug-resistant focal epilepsy who have undergone prior evaluations suggesting they may benefit from surgery.

Not a fit: Patients with behavioral deficits that prevent EEG recording or those without signed informed consent from parents may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the accuracy of surgical evaluations, leading to better outcomes for children with epilepsy.

How similar studies have performed: Previous studies using similar imaging techniques have shown varying success rates, indicating potential but also the need for further investigation.

Eligibility criteria

Inclusion Criteria:

1. Age≥2 and \<17 years;
2. Drug-resistant focal epilepsy (failure of at least 2 well-conducted drug trials);
3. 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;
4. Recent scalp EEG record (within 12 months) showing the presence of interictal spikes;
5. High-quality and recent (within 6 months) structural MRI with 3D-T1 sequences covering the whole brain and the scalp available.

Exclusion Criteria:

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

Where this trial is running

Angers and 8 other locations

• Angers university hospital, Pédiatric department — Angers, France (Recruiting)
• Lille University Hospital, Clinical Neurophysiology Department — Lille, France (Not_yet_recruiting)
• Civil Hospices of Lyon, Functional Neurology Department — Lyon, France (Not_yet_recruiting)
• Marseille Timone University Hospital, Epileptology and Cerebral Rhythmology Department — Marseille, France (Not_yet_recruiting)
• Nancy University Hospital, Neurology Department — Nancy, France (Not_yet_recruiting)
• Paris Neck University Hospital, Pediatric department — Paris, France (Not_yet_recruiting)
• Paris Robert-Debré University Hospital, Department of Physiology, Pediatric functional explorations — Paris, France (Not_yet_recruiting)
• Rothschild Ophtalmologic Fondation, Pediatric neurosurgery Department — Paris, France (Not_yet_recruiting)
• Rennes University Hospital, Pediatric department — Rennes, France (Not_yet_recruiting)

Study contacts

• Study coordinator: Patrick Van Bogaert, Professor

Conditions Epilepsy in Children