Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY
Paraules clau
Resum
Dates
| Darrera verificació: | 02/29/2020 |
| Primer enviat: | 01/25/2018 |
| Inscripció estimada enviada: | 01/25/2018 |
| Publicat per primera vegada: | 01/31/2018 |
| Última actualització enviada: | 03/12/2020 |
| Publicació de l'última actualització: | 03/15/2020 |
| Data d'inici de l'estudi real: | 03/15/2018 |
| Data estimada de finalització primària: | 03/16/2022 |
| Data estimada de finalització de l’estudi: | 03/16/2022 |
Condició o malaltia
Intervenció / tractament
Genetic: blood sample
Fase
Grups de braços
| Braç | Intervenció / tractament |
|---|---|
| Experimental: Patient Patients suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification and undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure | |
| Active Comparator: healthy volunteers Adult (≥ 18 years) Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders |
Criteris d'elegibilitat
| Edats elegibles per estudiar | 18 Years Per a 18 Years |
| Sexes elegibles per estudiar | All |
| Accepta voluntaris saludables | Sí |
| Criteris | Inclusion Criteria: For the patients : - Adult patient (≥ 18 years) suffering from drug-resistant focal epilepsy or from drug-resistant generalized epilepsy according to ILAE classification - Patient undergoing long-term video-EEG monitoring in Epilepsy unit of Lyon to record and characterize her/his seizure - Patient who gave her/his written informed consent to participate to the study - Patient affiliated to the French health care system For the healthy volunteers : - Adult (≥ 18 years) - Without history of neurological disorders and/or psychiatric disorders, and/or general medical disorders - Subject who gave her/his written informed consent to participate to the study - Subject affiliated to the French health care system Exclusion Criteria: For the patients : - Ongoing major depressive episode as defined by a score ≥ 15 at the French version of the NDDI-E scale* - Current panic disorder as defined by a score ≥ 7 at the French version of the GAD-7 scale* - Ongoing treatment with selective serotonin reuptake inhibitor - Patient who benefit from a protective measure For the healthy volunteers : - Presence of the symptoms of anxiety and/or depression as defined by a score ≥ 11 at the French version of the Hospital Anxiety and Depression Scale (HADS) - Ongoing treatment with selective serotonin reuptake inhibitor - Subjects with these psychiatric comorbidities and/or treatment will be excluded in order to limit risk that the relation previously reported between miR-135a, miR-16, miR-1202 and depression and/or panic disorder and/or response to selective serotonin |
Resultat
Mesures de resultats primaris
1. Relation between the expression level of circulating microRNAs and the occurrence of SpO2 <90% during at least 5 seconds within the course of the seizure and/or within the five minutes following the end of the seizure [Day 0]
Mesures de resultats secundaris
1. Relation between the expression level of circulating microRNAs and the desaturation nadir [Day 0]
2. Relation between the expression level of circulating microRNAs and the patient's age [Day 0]
3. Relation between the expression level of circulating microRNAs and the epilepsy duration [Day 0]
4. Relation between the expression level of circulating microRNAs and the total number of seizures (ie focal seizures and GTCS) over the past three months [Day 0]
5. Relation between the expression level of circulating microRNAs and the Number of GTCS over the past three months [Day 0]
