Clinical trial NCT02572297: National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
Official title: National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Drug-resistant Partial Epilepsy
Keywords: epilepsy
SUDEP
SpO2
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2015-10-08
Enrollment: 1072
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients suffering from drud-resistant partial epilepsy whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment

Brief summary: Sudden unexpected death in epilepsy (SUDEP) is the main concern of professionals and patient associations involved in epilepsy. These represent a priority for the Ligue Française Contre l'Epilepsie (LFCE). The SUDEP affect primarily young adults, between 18 and 40 years, suffering from epilepsy uncontrolled by medication. In this population of close to 100,000 people in France, the incidence of SUDEP is estimated at 0.5%, or nearly 500 deaths per year. It is clear that the majority of these deaths occur in the immediate consequences of a crisis..

Investigators suppose that a causal link exists between the occurrence of a SUDEP and a per / post-critic decline of SpO2 below 80 % (75 % of cases, 20 % of controls).The constitution of a cohort of 1500 patients clinically well described and a national database will allow other ambitious projects in a speciality where French centres benefit from a unique knowledge, recognized by their foreign colleagues, but underexploited to date. The LFCE (Ligue Française Contre l'Epilepsie) is developing structuring actions to facilitate such exploratory studies for the next two years.

The high death rate which characterizes the drug-resistant partial epilepsies and, in particular, Sudden Unexpected Deaths in Epilepsy (SUDEP) represents the main axis of research for the Ligue Française Contre l'Epilepsie (LFCE) as well as for associations of epileptic patients and the European representatives of the international league against epilepsy ( ILAE). Today, SUDEP occurrences cannot be anticipated. Patients can't be warned against SUDEP.

Although the SUDEP physiopathology remains uncertain, many elements plead for the essential role of a per-and post-critic apnea (central or obstructive). Investigators observe that about 20 % of the patients admitted in a EEG-video monitoring - EEG unit for recording their crisis are going to present experience an per / post-critic severe apnea, severe per / post-critic enough to have induce a SpO2 \< 80 % decrease.

However, today, no study has estimated the link relation between the arisen occurrence of such apneas and the later risk of SUDEP.


Eligibility criteria: Inclusion Criteria:

* patients suffering from drud-resistant partial epilepsy ;
* Patients who are at least 15 years ;
* Patients for whom a video-EEG monitoring of their seizures was scheduled as part of a pre-surgical assessment ;
* Patients having a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number
* Patients who have given their written consent ;
* Patients with a social security

Exclusion Criteria:

* Patients under 15 years
* Patients without drug-resistant partial epilepsy
* Patients without a registration number in the RNIP (Répertoire National d'Identification des Personnes Physiques) or a Social Security number)
* Patient without a consent signed

Primary outcomes:
measure: Number of patients with SpO2 < 80% decreases during the EEG-video monitoring
timeFrame: 6 and a half months
Secondary outcomes:
measure: Frequence of other known potential risk factors (composite measure : presence rate of each risk factor in SUDEP measured as percentage)
timeFrame: 6 and a half months
measure: Allelic frequency of genes involved in epileptogenesis (measured as percentage)
timeFrame: 6 and a half months
Other outcomes:
Locations:
city: Bron
country: France
facility: Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Pierre Wertheimer, Hospices Civils de Lyon
Study officials:
affiliation: Sercie de neurologie fonctionnelle et d'epileptologie, Hôpital Neurologique Pierre Wertheimer
name: Philippe RYVLIN, MD
role: PRINCIPAL_INVESTIGATOR
References: