NCT03268824

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
2mo left

Started Dec 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Dec 2017Jul 2026

First Submitted

Initial submission to the registry

August 29, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 31, 2017

Completed
4 months until next milestone

Study Start

First participant enrolled

December 19, 2017

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

January 5, 2026

Status Verified

December 1, 2025

Enrollment Period

8.5 years

First QC Date

August 29, 2017

Last Update Submit

December 30, 2025

Conditions

Epilepsies, FocalPediatricsDrug Resistant Epilepsy

Outcome Measures

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.

    Baseline

Study Arms (2)

Children / adolescents with drug-resistant focal epilepsy

Device: Electroencephalogram (EEG)Device: Diffusion Tensor imagingOther: Language assessment

Children / adolescents without drug-resistant focal epilepsy

Device: Diffusion Tensor imagingOther: Language assessment

Interventions

Electroencephalogram (EEG)DEVICE

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).

Children / adolescents with drug-resistant focal epilepsy
Diffusion Tensor imagingDEVICE

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.

Children / adolescents with drug-resistant focal epilepsyChildren / adolescents without drug-resistant focal epilepsy
Language assessmentOTHER

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

Children / adolescents with drug-resistant focal epilepsyChildren / adolescents without drug-resistant focal epilepsy

Eligibility Criteria

Age18 Months - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Children/adolescents with drug resistant focal epilepsy.

You may qualify if:

  • \- Drug resistant focal epilepsy
  • \- without drug resistant focal epilepsy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondation Ophtalmologique A. de Rothschild

Paris, France

RECRUITING

MeSH Terms

Conditions

Epilepsies, PartialDrug Resistant Epilepsy

Interventions

ElectroencephalographyDiffusion Tensor Imaging

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisNeuroimagingDiagnostic ImagingDiffusion Magnetic Resonance ImagingMagnetic Resonance ImagingTomographyInvestigative Techniques

Study Officials

  • Vera Dinkelacker, MD PhD

    Fondation Ophtalmologique A. de Rothschild

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Laurence Salomon, MD PhD

CONTACT

0148036431lsalomon@for.paris

Vera Dinkelacker, MD PhD

CONTACT

0148036853vdinkelacker@for.paris

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2017

First Posted

August 31, 2017

Study Start

December 19, 2017

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

January 5, 2026

Record last verified: 2025-12

Locations

FR(1)