CompletedNot Applicable

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

France1,072 participantsStarted 2010-05-18

Plain-language 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.

Who can participate

Age range

15 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial specifically studied people with drug-resistant partial epilepsy — does my diagnosis fit that category, and what does it mean that I haven't responded to medications so far?
2The trial tracked episodes where blood oxygen dropped below 80% during video-EEG monitoring — is that kind of dangerous oxygen drop something my doctor thinks could be happening to me during my seizures without us knowing?
3Since this study has already been completed, are there published results showing which patients were most at risk for these oxygen drops, and could those findings change how my seizures are monitored or managed?
4This trial focused on understanding predictors of sudden unexpected death in epilepsy (SUDEP) — is SUDEP a real risk I should be talking about with my care team given my type of epilepsy, and what steps can I take to lower that risk?
5Now that this research is done, are there any follow-up studies or clinical programs at my hospital that use what was learned here to actively prevent dangerous events in people with drug-resistant partial epilepsy like mine?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with SpO2 < 80% decreases during the EEG-video monitoring

Timeframe: 6 and a half months

Trial details

NCT IDNCT02572297

SponsorHospices Civils de Lyon

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2015-02

View on ClinicalTrials.gov More Drug-resistant Partial Epilepsy trials