NCT03268824 Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain
| NCT ID | NCT03268824 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondation Ophtalmologique Adolphe de Rothschild |
| Condition | Epilepsies, Focal |
| Study Type | OBSERVATIONAL |
| Enrollment | 82 participants |
| Start Date | 2017-12-19 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 82 participants in total. It began in 2017-12-19 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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 * 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
Contact & Investigator
Vera Dinkelacker, MD PhD
PRINCIPAL INVESTIGATOR
Fondation Ophtalmologique A. de Rothschild
Frequently Asked Questions
Who can join the NCT03268824 clinical trial?
This trial is open to participants of all sexes, aged 18 Months or older, up to 16 Years, studying Epilepsies, Focal. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03268824 currently recruiting?
Yes, NCT03268824 is actively recruiting participants. Contact the research team at lsalomon@for.paris for enrollment information.
Where is the NCT03268824 trial being conducted?
This trial is being conducted at Paris, France.
Who is sponsoring the NCT03268824 clinical trial?
NCT03268824 is sponsored by Fondation Ophtalmologique Adolphe de Rothschild. The principal investigator is Vera Dinkelacker, MD PhD at Fondation Ophtalmologique A. de Rothschild. The trial plans to enroll 82 participants.