Status:
RECRUITING
Caracterization of the Combined Alterations in Respiration and AROUSal in Patients with Drug-resistant EpiLepsy
Lead Sponsor:
Hospices Civils de Lyon
Conditions:
Epilepsy
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, from cognitive dysfunctions to premature mortality. Both seizures and their complic...
Eligibility Criteria
Inclusion
- Patients :
- Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
- Aged 18 to 55 years old
- Diagnosis of focal epilepsy
- Epilepsy is refractory to treatment, as defined by the International League Against Epilepsy
- Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) during the past 18 months
- Patients who had undergone long-term video-EEG (VEEG) monitoring for presurgical evaluation in the past ten years within the Department of Functional Neurology and Epileptology at Hospices Civils de Lyon, ensuring access to detailed information about:
- occurrence of transient respiratory dysfunction during the focal seizures, transient hypoxemia during strictly focal seizures being observed in 40% of patients(39) and in 87% of patients with at least one FBTCS during the VEEG monitoring(46)
- localization of the epileptogenic zone, the risk of peri-ictal respiratory dysfunction being greater in seizures of temporal lobe origin than in extra-temporal seizures, even after FBTCS
- Healthy subjects
- Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study
- Aged 18 to 55 years old
Exclusion
- Patients
- Ongoing or chronic respiratory and/or cardiac insufficiency
- Obstructive sleep-apnea syndrome
- Ongoing treatment with selective serotonin reuptake inhibitor
- Patient treated with vagal nerve stimulation
- Pregnant women or breastfeeding women, based on declarations at V0
- Persons receiving psychiatric care
- Persons deprived of their liberty by a judicial or administrative decision
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Positive urine pregnancy test at V1, if applicable
- Healthy subjects
- History of epilepsy
- Ongoing or chronic respiratory and/or cardiac insufficiency
- Obstructive sleep-apnea syndrome
- Pregnant women, women in labor or breastfeeding women, based on declarations at V0
- Persons receiving psychiatric care
- Persons deprived of their liberty by a judicial or administrative decision
- Adults subject to a legal protection measure (guardianship, curatorship)
- Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
- Positive urine pregnancy test at V1, if applicable
Key Trial Info
Start Date :
November 4 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 4 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06545214
Start Date
November 4 2024
End Date
January 4 2027
Last Update
January 6 2025
Active Locations (1)
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1
Hôpital Pierre Wertheimer
Bron, Rhone, France, 69500