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This study uses video-EEG and blood samples to examine the neurodevelopmental impact of epilepsy on autonomic nervous system function in Dravet syndrome (a genetic form of epilepsy). It enrolls children aged 2-18 and adult patients under 60 with a confirmed diagnosis. It is a study without a phase; it is not currently recruiting but is still ongoing (active, not recruiting).
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Children (\> 2 years and \< 18 years) and adult patients (\< 60 years) with established diagnosis of Dravet Syndrome * Adults protected by a guardianship or curatorship * Diagnosis of Dravet syndrome will be confirmed by PI of each study center based on medical history, type of seizures, EEG data and results of genetic testing * No restriction related to the seizure frequency * Patient (or patient's parents or legal representative) who gave its written informed consent to participate to the study * At least one of the parents and/or legal representative understanding and speaking national language * Written consent form signed by both parents * Absence of known current pregnancy and breastfeeding * Patient affiliated to its national health care system Exclusion Criteria: * Patients (children or adults) unable to tolerate at least 24 hours of video-EEG recordings (behavioural problems resulting in technical issues for appropriate EEG recordings) * Patients with congenital heart or lung disease * Patients with congenital abnormalities or diseases, other than the epilepsy, which could interfere with sleep * Subject in exclusion period of another study