Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain (NCT03268824) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain
France82 participantsStarted 2017-12-19
Plain-language 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.
Who can participate
Age range
18 Months – 16 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Correlation between the number of cerebral disconnections and the epileptogenicity index
Timeframe: Baseline
Trial details
NCT IDNCT03268824
SponsorFondation Ophtalmologique Adolphe de Rothschild