Status:
COMPLETED
Circulating microRNAs as Biomarkers of RESPIratory Dysfunction in Patients With Refractory epilePSY
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Drug Resistant Epilepsy
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Sudden and unexpected death in epilepsy (SUDEP) has become a major issue for patients with epilepsy and their physicians. SUDEP is a nontraumatic and non-drowning death in patients with epilepsy, unre...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT03419000
Start Date
March 16 2018
End Date
March 31 2022
Last Update
September 24 2025
Active Locations (2)
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1
Hospices Civils de Lyon
Bron, France, 69500
2
Service de Neurophysiologie Clinique Hôpital La Timone
Marseille, France, 13005