Neurodevelopmental Impact of Epilepsy on Autonomic Function in Dravet Syndrome

Launched by HOSPICES CIVILS DE LYON · Jul 22, 2022

Keywords

ClinConnect Summary

The AUTONOMIC project is a clinical trial studying how epilepsy affects breathing and heart function in patients with Dravet Syndrome, a severe form of epilepsy that often starts in childhood and is difficult to treat. The researchers want to understand the relationship between the frequency of seizures, the underlying neurological condition, and changes in autonomic functions (which control automatic bodily processes like breathing and heart rate) both during and between seizures. This research is important because it aims to identify ways to prevent sudden unexpected death in epilepsy (SUDEP), a serious risk for patients with Dravet Syndrome.

To participate in this study, children over 2 years old and adults under 60 with a confirmed diagnosis of Dravet Syndrome can join. Participants will go through a period where their seizure frequency is monitored, followed by a 24-48 hour recording of their brain activity (video-EEG) and a full-night sleep study. The study will take place across three clinical centers over the next two years, and families will be involved in the process by providing consent. Overall, this project seeks to gather important information that could lead to better treatments and understanding of the risks associated with Dravet Syndrome.

Gender

ALL

Eligibility criteria

• 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