Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-16
SponsorFondation Ophtalmologique Adolphe de Rothschild
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Severe mental retardation (IQ < 50)
Lack of French-language skills
Contraindications to MRI
Bi-hemispherical epilepsy or affecting multiple lobes
Trial population
Children/adolescents with drug resistant focal epilepsy.
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
Electroencephalogram (EEG)
DeviceIntracerebral 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).
Diffusion Tensor imaging
DeviceWe 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.
Language assessment
Other interventionThe language assessment will be adapted to the age of the child, with a predominant neuropsychological component.
Treatment groups
82 Participants
are divided into 2 treatment groupsGroup A: Children / adolescents with drug-resistant focal epilepsy3 interventions
Group B: Children / adolescents without drug-resistant focal epilepsy2 interventions
Trial outcomes
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
BaselineSponsors and contacts
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Source ClinicalTrials.gov