REPOMSE - Cohort of patients with refractory epilepsy initially admitted to video-EEG monitoring unit
Head :
Ryvlin Philippe, INSERM U821 (DYNAMIQUE CÉRÉBRALE ET COGNITION) et CTRS-INSERM COGNITIVE DEVELOPMENT IN EPILEPSY UNIVERSITÉ CLAUDE BERNARD LYON 1
Last update : 06/24/2014 | Version : 1 | ID : 60180
| General | |
| Identification | |
| Detailed name | Cohort of patients with refractory epilepsy initially admitted to video-EEG monitoring unit |
| Sign or acronym | REPOMSE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°910398 - AFSSAPS : B1001-08-40 - CPP : 2010-006-2 |
| General Aspects | |
| Medical area |
Neurology Radiology and medical imaging |
| Keywords | sudden unexpected death in epilepsy (SUDEP), accidents caused by epileptic seizures, status epilepticus, recovery, improvement, stability, hospitalised subjects, Health episodes, death, comorbidities, suicide, progression, aggravation, health system |
| Scientific investigator(s) (Contact) | |
| Name of the director | Ryvlin |
| Surname | Philippe |
| Address | 69622 VILLEURBANNE |
| Phone | + 33 (0)4 72 35 71 17 |
| ryvlin@cermep.fr | |
| Unit | INSERM U821 (DYNAMIQUE CÉRÉBRALE ET COGNITION) et CTRS-INSERM COGNITIVE DEVELOPMENT IN EPILEPSY UNIVERSITÉ CLAUDE BERNARD LYON 1 |
| Organization | Inserm |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Mixed |
| Details | Programme hospitalier de recherche clinique, les 14 CHU concernés, Ligue Française contre l'Epilepsie, Laboratoires pharmaceutiques EISAI au travers de donations à la LFCE |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Hospices civils de Lyon |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Prospective |
| Database objective | |
| Main objective | General Objective: To determine the main risk factors for sudden unexpected death in epilepsy (SUDEP), focusing on the impact of critical and post-critical apnoea as well as the origin site of a seizure. Secondary objective: to obtain systematic data related to: - inpatient treatment modalities for EGG-video monitoring; - long-term follow-up of patients on a medical or medico-economic plan; - results of epilepsy surgery; - serious comorbidities associated with epilepsy (including increased mortality); - Genetic susceptibility factors (systematic genotyping). |
| Inclusion criteria | Patients with refractory epilepsy admitted to a video-EEG monitoring unit to characterise their seizure type (for surgical treatment for epilepsy or to better identify their epileptic syndrome) |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout France (14 centres): The 14 centres participating in the study represent the bulk of institutions benefiting from long-term video-EGG monitoring treatment for patients who meet the inclusion criteria |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 06/2010 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 933 (juillet 2013) |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Declarative data (detail) |
Paper self-questionnaire Face to face interview |
| Paraclinical data (detail) | Imaging and electrophysiology Patients will be included during long-term video-EEG monitoring in order to record and characterise their seizures. This monitoring will provide very precise clinical (video of seizure) and electroencephalographic (scalp EEG see intracranial) information for critical and intercritical events. Using other sophisticated investigative data (MRI, functional MRI, positron emission tomography, ictal SPECT, MEG), this information will be used to establish the probable origin site of seizures and to look at surgical resection of the latter in order to control the disorder. This vital information is key to the phenotypic characterisation of the cohort and requires a significant number of man hours in order to be properly collected and coded. It is particularly relevant concerning the criteria for evaluating the health of the population being examined (especially SUDEP risk). |
| Biological data (detail) | Type of samples taken: blood sample |
| Presence of a biobank |
Yes |
| Contents of biobank |
DNA |
| Details of biobank content | DNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: entry from a paper questionnaire (manual input); Interviews: entry from a paper questionnaire (manual input); Biological analysis: handwritten (manual input) |
| Participant monitoring |
Yes |
| Details on monitoring of participants | (Indefinite duration) |
| Links to administrative sources |
Yes |
| Linked administrative sources (detail) | PMSI, CépiDc, CRAM, INSEE database for vital status. Epilepsy database accessible online in order to obtain cohort patient data: GRENAT (National Epilepsy Group Register) |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.lfce.fr/Publication_a80.html |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Data may not be used by industrial teams |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
