Clinical trial Recruiting at 1 site Observational Ages 18 Months to 16

How seizures affect brain wiring in children with focal epilepsy

Official title: Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain: Combination of Intracerebral Stereotactic Electroencephalography Recording and Diffusion Tensor Imaging in Children With Drug-resistant Focal Epilepsy

Run by Fondation Ophtalmologique Adolphe de Rothschild · NCT03268824 · Data updated 2026-11-12

This project tests whether ongoing seizures change the brain's white-matter wiring in children with drug-resistant focal epilepsy who are being evaluated for surgery.

Quick facts

Study typeObservational
Ages18 Months to 16 Years
SexAll
Enrollment82 (estimated)
SponsorFondation Ophtalmologique Adolphe de Rothschild
Research network
Locations1 site (Paris)
StatusRecruiting
StartedDecember 19, 2017
Main results expectedJune 2026
Study endsJuly 2026
Registry record updatedJanuary 5, 2026
Trial IDNCT03268824 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are children with drug-resistant focal epilepsy who are undergoing presurgical intracerebral electrode evaluation, can tolerate MRI, speak French, and do not have severe intellectual disability, multi-lobar or bihemispheric epilepsy, major sensory loss, or congenital connectivity disorders.

Probably not a fit

Children with IQ below 50, contraindications to MRI, bi-hemispheric or multi-lobar epilepsy, congenital brain connectivity disorders, autism, or major sensory impairments are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study combines intracerebral stereotactic EEG (SEEG) recordings with diffusion-weighted MRI tractography in children undergoing presurgical evaluation for drug-resistant focal epilepsy. Diffusion MRI is acquired before electrode implantation to map white-matter fibers, and SEEG recordings are used to compute an epileptogenicity index for each contact to quantify local seizure discharge intensity. Locally, the study correlates regions of reduced structural connectivity with epileptogenicity at nearby contacts; globally, it compares left and right hemisphere fiber patterns to probe preservation of language lateralization. A control group without drug-resistant focal epilepsy is included to help distinguish seizure-related changes from developmental or congenital differences.

Why it matters

Potential benefit: If ongoing seizure-related changes to brain connections are demonstrated, the findings could help guide surgical targeting and explain cognitive problems, potentially improving surgical outcomes and long-term development.

How similar studies have gone: Prior diffusion tractography studies have shown widespread connectivity alterations in focal epilepsy, but directly linking those changes to intracerebral seizure activity using combined SEEG-DWI methods is relatively novel and not yet proven.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

\- Drug resistant focal epilepsy

Inclusion Criteria for control patients:

\- without drug resistant focal epilepsy

Exclusion Criteria:

* Severe mental retardation (IQ \< 50)
* Lack of French-language skills
* Contraindications to MRI
* Bi-hemispherical epilepsy or affecting multiple lobes

Exclusion Criteria for control patients:

* Severe mental retardation (IQ \< 50)
* Lack of French-language skills
* Contraindications to MRI
* Congenital pathology altering cerebral connectivity
* Parenchymal brain lesions
* Unilateral or bilateral blindness
* Unilateral or bilateral deafness
* Autistic disorders

Where it's running

  • Fondation Ophtalmologique A. de Rothschild
    Paris, France
    Recruiting

Study contacts

  • Principal investigator: Vera Dinkelacker, MD PhD — Fondation Ophtalmologique A. de Rothschild
  • Study coordinator: Laurence Salomon, MD PhD
  • Email: lsalomon@for.paris
  • Phone: 0148036431

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.