National Network for the Study of Predictors and Prevention of Sudden Unexpected Death in Drug-resistant...
Drug-resistant Partial EpilepsySudden 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.
Seizure Detection and Warning System in Epilepsy Patients
EpilepsyGeneralized Tonic-Clonic SeizuresThis is a phase III, pilot, prospective study of an Electromyography (EMG) based seizure detection system for detecting Generalized Tonic-Clonic Seizures (GTCS) in the home.
Cannabidiol for Pediatric Epilepsy (Compassionate Use)
Refractory Childhood EpilepsyThis is an open-label observational study of pure CBD for the treatment for 25 children with intractable epilepsy. As pure CBD is not FDA approved, the investigators are conducting this study via the FDA expanded access mechanism on a compassionate use basis. The target patient population is children with severe refractory epilepsy who have exhausted all other reasonable avenues of treatment. These are patients for whom the risks of a relatively untested product are outweighed by the potential benefit. Using seizure-diaries maintained on a routine clinical basis, seizure frequency will be assessed four weeks prior to initiation of CBD, one month after CBD initiation, and at least every 3 months thereafter. CBD will be administered as an adjunct to all current anti-epileptic therapies.
Cerebral Autoregulation in Patients With Epilepsy
EpilepsyThe purpose of this study is to determine whether patients with epilepsy exhibiting impaired dCA, which may contribute to subsequent stroke.
Thermographic Examination of Skin Temperatures in Individuals With Focal Onset Epilepsy
Focal Onset EpilepsyPartial EpilepsyThe specific aim is to determine if there are patterns of temperature differences in the abdominal and back regions of individuals with partial/focal onset epilepsy as compared to a non-epileptic control group. The hypothesis is that individuals with partial/focal onset epilepsy will have colder recorded temperatures in the abdominal area than individuals in a matched control group.
An Observational Study to Assess the Burden of Drug-resistant Partial Epilepsy in Italy
EpilepsyPartialobservational, non-interventional study in 120 patients with drug-resistant partial epilepsy, comprising two phases: a 3-month retrospective and a 6-month prospective. As control group, 120 patients with controlled partial epilepsy will be enrolled. The objective of the study is to describe the burden of illness in this epileptic population both in terms of costs and of quality of life. Costs and quality of life will be also compared between the two populations.
Safety and Tolerability of Cannabidiol in Subjects With Drug Resistant Epilepsy
EpilepsyThis is an observational, open-label, flexible dose study that will prospectively and longitudinally assess the effect of Cannabidiol (CBD) therapy in patients with drug-resistant epilepsies through a Physician Expanded Access Investigational New Drug protocol.
Epilepsy Motion Sensing
EpilepsyEvaluate patient motion during seizures.
Heart Rate Changes During Normal Activity, Exercise, and Seizures in Subjects With Epilepsy
EpilepsyCharacterization of the cardiac response (ECG) preceding an epileptic seizure.
Women With Epilepsy: Pregnancy Outcomes and Deliveries
EpilepsyThis is a three-center prospective case-control study to examine the patterns of fertility among women with epilepsy (WWE) compared to an age-matched group of women without epilepsy (WWoE).