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New treatment option for Epilepsy
Official title Caracterization of the Combined Alterations in Respiration and aROUSal in Patients With Drug-resistant EpiLepsy
ClinicalTrials.gov ID: NCT06545214
What this study is testing
- What it's testing
- 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 complications are modulated by patients' vigilance states, with a tight and bi-directional interplay between sleep and epilepsy.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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...
- 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...
- 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 people
- 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
- 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 people
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bron, Rhone, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bron, Rhone, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.