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RecruitingNCT03268824EPITRACTUpdated Jan 5, 2026

Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain

An observational study in Epilepsies, Focal, Pediatrics and Drug Resistant Epilepsy, sponsored by Fondation Ophtalmologique Adolphe de Rothschild. Recruiting at 1 site in France. Open to participants aged 18 Months to 16 Years. Per ClinicalTrials.gov, last updated 2026-01-05.

Sponsored by Fondation Ophtalmologique Adolphe de Rothschild · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2026, 5 months ago, but the record still lists the study as recruiting.
  • Started Dec 2017; still recruiting 8 years 10 months later.
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
82
Ages
18 Months to 16 Years
Sex
All
01

Study summary

Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. This study intends to measure the impact of seizures on structural connectivity on a local and on a global level. In children examined with intracerebral electrodes to evaluate whether a surgical cure can be proposed, we combine intracerebral stereotactic electroencephalography (EEG) recordings with diffusion weighted imaging of white matter fibers. On the local level, the study will quantify the number of deficient connections in the seizure onset zone. On a global level, the study will compare the white matter fibers of the left and right hemisphere to probe whether physiological language lateralization is preserved.

Read the detailed description

Drug-resistant focal epilepsy is a debilitating disease as it is often accompanied by learning disabilities and behavioral disorders, that can be present at the disease onset and have ample repercussions on the child's quality of life.

Despite a focal onset of seizures, the dysfunction of the cerebral networks is diffuse. Structural brain connectivity can be measured with diffusion tractography, which has shown evidence of widespread network pathology in focal epilepsy, probably explaining the associated learning disabilities. Whether ongoing seizure activity further modifies network wiring and possibly generates abnormal pathways along the routes of seizure propagation is a matter of debate.

The study intends to probe the effect of seizures on cerebral connectivity, both on a local and on a global level. Children who undergo presurgical evaluation to probe whether their epilepsy can be cured by surgery are recorded with implanted intracerebral electrodes for clinical purposes. A diffusion Magnetic Resonance Imaging will be performed prior to implantation in order to relate tractography measures to seizure recordings. On the local level, intracerebral electroencephalogram (EEG) will be analysed to quantify the intensity of epileptic discharge (the epileptogenicity index) on each electrode contact. Loss of connectivity (or disconnections) is determined with diffusion tractography for each brain region. Then correlation between the degree of epileptogenicity and with the number of disconnections will be studied.

On a global level, the study will quantify all white matter fibers within the language area (Broca's) in the left and the corresponding area in the right hemisphere. The difference between hemispheres yields us the lateralization index. The secondary outcome probes whether children with focal epilepsy have atypical language organization, as a measure of diffuse changes in brain wiring.

02

Conditions studied

  • Epilepsies, Focal
  • Pediatrics
  • Drug Resistant Epilepsy
03

In context

Epilepsies, Partial

243 studies on the registry are indexed under Epilepsies, Partial; 49 are open to participants now.

This study's planned enrollment of 82 is below the median of 130 across 47 observational studies indexed under Epilepsies, Partial.

Browse Epilepsies, Partial studies →

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild is the lead sponsor of 316 studies on the registry; 78 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Months to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children/adolescents with drug resistant focal epilepsy.

Eligibility 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
  • 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
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

Observational model
Other
Time perspective
Cross-sectional
Enrollment
82 participants (estimated)
Patient registry
No

Groups and cohorts

  • Children / adolescents with drug-resistant focal epilepsy

    Device: Electroencephalogram (EEG) · Device: Diffusion Tensor imaging · Other: Language assessment

  • Children / adolescents without drug-resistant focal epilepsy

    Device: Diffusion Tensor imaging · Other: Language assessment

Interventions

  • DeviceElectroencephalogram (EEG)

    Intracerebral electroencephalogram (EEG) will be analysed to quantify the intensity of epileptic discharge (the epileptogenicity index) on each electrode contact (only for children with focal epilepsy).

  • DeviceDiffusion Tensor imaging

    We will perform Diffusion Tensor imaging in order to relate tractography measures to seizure recordings. Loss of connectivity (or disconnections) will be determined with diffusion tractography for each brain region. Then we will correlate the degree of epileptogenicity with the number of disconnections.

  • OtherLanguage assessment

    The language assessment will be adapted to the age of the child, with a predominant neuropsychological component.

06

What researchers measure

Primary outcomes

  1. Correlation between the number of cerebral disconnections and the epileptogenicity index

    The epileptogenicity index is based on measurement of the intensity of rapid frequency discharges in relation to the cerebral activity outside the seizures.

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03268824
Responsible party
Sponsor
First posted
Aug 31, 2017
Start date
Dec 19, 2017
Primary completion
Jun 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
Jan 5, 2026

Study contacts

Laurence Salomon, MD PhD
Contact
lsalomon@for.paris
0148036431 ext. +33
Vera Dinkelacker, MD PhD
Contact
vdinkelacker@for.paris
0148036853 ext. +33
Vera Dinkelacker, MD PhD
principal investigator · Fondation Ophtalmologique A. de Rothschild

Oversight

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

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