Impact of epilepsy on autonomic function in Dravet Syndrome
Neurodevelopmental Impact of Epilepsy on Autonomic Function in Dravet Syndrome
This study is trying to see how epilepsy affects the body's automatic functions in children and adults with Dravet Syndrome to better understand the risks of sudden unexpected death in epilepsy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 60 Years |
| Sex | All |
| Sponsor | Hospices Civils de Lyon Academic / other |
| Locations | 4 sites (Edegem and 3 other locations) |
| Trial ID | NCT05472389 on ClinicalTrials.gov |
What this trial studies
This study investigates the neurodevelopmental effects of epilepsy on autonomic function in patients with Dravet Syndrome, a severe form of epilepsy characterized by drug-resistant seizures and cognitive deficits. It involves the use of video-electroencephalography and blood samples to assess the relationship between seizure activity and autonomic dysfunction. The study aims to better understand the mechanisms behind sudden unexpected death in epilepsy (SUDEP) in this patient population. Participants will include children and adults diagnosed with Dravet Syndrome, with data collected over a specified period.
Who should consider this trial
Good fit: Ideal candidates for this study are children over 2 years and adults under 60 years with a confirmed diagnosis of Dravet Syndrome.
Not a fit: Patients unable to tolerate at least 24 hours of video-EEG recordings due to behavioral issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of autonomic dysfunction in patients with Dravet Syndrome, potentially reducing the risk of SUDEP.
How similar studies have performed: While there is ongoing research into SUDEP and its mechanisms, this specific approach focusing on autonomic function in Dravet Syndrome is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Edegem and 3 other locations
- Department of Paediatrics and Paediatric Neurology, Antwerp University Hospital — Edegem, Belgium (Not_yet_recruiting)
- HFME Hospices Civils de Lyon — Bron, Rhone, France (Recruiting)
- Hôpital Neurologique Pierre Wertheimer Hospices Civils de Lyon — Bron, Rhone, France (Recruiting)
- Klinik und Poliklinik für Epileptologie, Universitätsklinikum — Bonn, Germany (Not_yet_recruiting)
Study contacts
- Study coordinator: Sylvain RHEIMS, Pr
- Email: Sylvain.rheims@chu-lyon.fr
- Phone: 0472357106
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.