National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant Partial Epilepsies

NCT ID: NCT02572297

Last Updated: 2025-12-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1072 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-05-18
• Study Completion Date: 2015-08-23

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.

Conditions

Drug-resistant Partial Epilepsy

Keywords

epilepsy; SUDEP; SpO2

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

video-EEG

Patients suffering from drug-resistant partial epilepsy for whom a video-EEG monitoring of their seizures was scheduled as part of pre-surgical assessment

video-EEG

Intervention Type: OTHER

Registration of seizures during video-EEG

Interventions

video-EEG

Registration of seizures during video-EEG

Intervention Type: OTHER

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

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe RYVLIN, MD

Role: PRINCIPAL_INVESTIGATOR

Sercie de neurologie fonctionnelle et d'epileptologie, Hôpital Neurologique Pierre Wertheimer

Locations

Service de Neurologie Fonctionnelle et d'Epileptologie, Hôpital Pierre Wertheimer, Hospices Civils de Lyon

Bron, , France

Countries

France

Other Identifiers

2009.582

Identifier Type: -

Identifier Source: org_study_id