[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"drug-resistant-focal-epilepsy\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:drug-resistant-focal-epilepsy":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":4},"100616110","easee-system-pivotal-study-for-the-united-states-of-america-100616110",false,"NCT07301346","EASEE® System Pivotal Study for the United States of America","EASEE4US","Inclusion Criteria:\n\n* Adult between 18-75 years of age\n* Diagnosis of drug-resistant focal epilepsy\n* At least four (4) observable seizure manifestations per month\n* Stable anti-seizure medication regimen\n\nExclusion Criteria:\n\n* Diagnostic of non-epileptic seizures\n* Active idiopathic generalized epilepsy\n* Recent status epileptics (\\\u003C12 months)\n* Clinically significant or unstable medical condition\n* Active psychosis, major depression, suicidal ideation (\\\u003C6 months)\n* Pregnancy\n* Implanted with brain stimulation device or active Vagus Nerve Stimulation","ALL","18 Years","75 Years",{"count":20,"type":21},200,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are:\n\n1. Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase?\n2. Is the use of EASEE(R) System safe after up to 28 and up to 84 days?\n\nParticipants will be asked to:\n\n* Complete a seizure diary for the duration of the clinical trial\n* Attend study visits for 20 months of their clinical trial participation\n* Undergo EASEE(R) System implant\n* Not be aware if neurostimulation is delivered during the Blinded Phase (6 months)\n* Receive neurostimulation for at least 12 months",[27],"Drug-Resistant Focal Epilepsy",[29,30,31,32,33],"EASEE System","Precisis","Neurostimulation","Epilepsy","Focal Cortex Stimulation","NOT_YET_RECRUITING","2026-04-27",{"date":37,"type":38},"2026-05-01","ACTUAL",{"date":40,"type":21},"2026-07-01",{"date":42,"type":21},"2030-07-01",{"name":44,"class":45},"Precisis US, Inc.","INDUSTRY",{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100612088","impact-of-epilepsy-on-the-brainstem-adenosine-pathway-and-its-relation-with-arousal-and-respiratory-reactivity-100612088","NCT07249034","Impact of Epilepsy on the Brainstem Adenosine Pathway and Its Relation With Arousal and Respiratory Reactivity","BRAVE","Inclusion Criteria:\n\n* For patients\n\n  1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study\n  2. Aged 18 to 55 years old\n  3. Diagnosis of focal epilepsy or of idiopathic generalized epilepsy, as defined by the International League Against Epilepsy\n  4. Diagnosis of refractory epilepsy, as defined by the International League Against Epilepsy\n  5. Patients with ≥3 focal to bilateral tonic-clonic seizure (FBTCS) during the past 18 months\n  6. For women of childbearing potential, use effective contraception during study participation\n* For healthy volunteers\n\n  1. Written informed consent obtained from study subject and ability for study subject to comply with the requirements of the study\n  2. Aged 18 to 55 years old\n  3. For women of childbearing potential, use effective contraception during study participation\n\nExclusion Criteria:\n\n* For patients\n\n  1. Ongoing or chronic respiratory and\u002For cardiac insufficiency\n  2. Obstructive sleep-apnea syndrome\n  3. Ongoing treatment with selective serotonin reuptake inhibitor\n  4. MRI contra-indication (presence of metallic elements, claustrophobia)\n  5. Patient treated with vagal nerve stimulation or deep brain stimulation\n  6. Pregnant women, women in laboror breastfeeding women, based on declarations at V0\n  7. Persons under psychiatric care\n  8. Persons deprived of their liberty by a judicial or administrative decision\n  9. Adults subject to a legal protection measure (guardianship, curatorship)\n  10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n  11. Positive urine pregnancy test at V2, if applicable\n  12. Hypersensitivity to \\[18F\\]-CPFPX\n* For healthy volunteers\n\n  1. History of epilepsy\n  2. Ongoing or chronic respiratory and\u002For cardiac insufficiency\n  3. Obstructive sleep-apnea syndrome\n  4. Ongoing treatment with selective serotonin reuptake inhibitor\n  5. MRI contra-indication (presence of metallic elements, claustrophobia)\n  6. Pregnant women, women in labor or breastfeeding women, based on declarations at V0\n  7. Persons under psychiatric care\n  8. Persons deprived of their liberty by a judicial or administrative decision\n  9. Adults subject to a legal protection measure (guardianship, curatorship)\n  10. Persons not affiliated to a social security scheme or beneficiaries of a similar scheme\n  11. Positive urine pregnancy test at V2, if applicable\n  12. Hypersensitivity to \\[18F\\]-CPFPX",true,"55 Years",{"count":56,"type":21},50,[24],"Despite the continuous development of new antiseizure medications over the past 25 years, 30% of patients with epilepsy suffer from drug-resistant seizures and are at risk of epilepsy-related complications, like cognitive dysfunctions, sleep-disordered breathing or Sudden and Unexpected Death in Epilepsy (SUDEP). SUDEP typically occurs during sleep, after a nocturnal seizure, and primarily results from a postictal central respiratory dysfunction in patients with generalized convulsive seizure (GCS), suggesting that interaction between respiratory dysfunction and sleep state may play a role in its pathophysiology.\n\nPost-mortem data in SUDEP patients showed alteration of neuronal populations involved in respiratory control in the medulla. Accordingly, pharmacologic strategies aimed at reducing the severity of postictal respiratory dysfunction has appeared as one of the most promising way to prevent SUDEP. However, no encouraging result has hitherto been reported.\n\nInterconnections between the complex network that regulates arousal and sleep and the respiratory network are numerous. They primarily include the relation between chemosensitive regulation and arousal system to ensure asphyxia-induced arousal (i.e. arousal to elevated CO2), especially through serotonin (5HT)-dependent connections in brain stem. The link between alterations of the brainstem networks involved in arousal regulation and respiratory dysfunction has not been characterized in patients with epilepsy yet.\n\nLike 5HT, adenosine is deeply implicated in the regulation of sleep and central respiratory control.\n\nSeizures transiently increase adenosine extracellular levels. Adenosine physiological effects in the brain are mediated through the activation of two types of Adenosine receptors (ARs), A1Rs and A2ARs. Extracellular adenosine promotes sleep via A1R-dependant inhibition of glutamatergic neurons in the basal forebrain, but also via A2AR-dependant activation of neurons in the nucleus accumbens. Respiration is also inhibited by A1R and A2AR. Most importantly, it has been shown that drug-resistant epilepsy is associated with long-term alterations of ARs cortical expression. However, whether or not a similar epilepsy-related plasticity of ARs occurs in the brainstem and may participate to chronic arousal and respiratory dysfunction in epilepsy has never been investigated.\n\nConsidering the tight interplay between central respiratory control, arousal regulation and brainstem adenosine, the main hypothesis of the BRAVE study is that epilepsy might result in alterations of the distribution of A1Rs in the brainstem structures involved in respiratory regulation and\u002For arousal control, especially in the brainstem structures involved in respiratory regulation under hypercapnic condition.\n\nThe study combines clinical respiratory characterization, morphological, functional and metabolic imaging, using the hybrid simultaneous 3T MRI-PET scanner (Siemens Biograph mMR) of the CERMEP. Combining PET with anatomical and functional MR imaging enables non-invasively in vivo mapping of receptor binding and functional neuronal assessment of a physiological task in the entire brain with high spatial resolution.\n\nInvestigators already performed fMRI study of respiratory centers, showing number of functional changes in brainstem regions participating to the central control of respiration, including reduced activation during breath-holding fMRI, in patients with epilepsy. The BRAVE study will use the same respiratory paradigm as the one used in this past study.\n\nPET imaging will be focused on A1R, using \\[18F\\]CPFPX, a selective A1R antagonist.",[32,60,61],"Drug-resistant Focal Epilepsy","Healthy Controls",[32,63,64,65,66],"adenosine pathway","respiratory reactivity","PET-MRI","[18F]CPFPX","2025-11-21",{"date":69,"type":38},"2025-11-25",{"date":71,"type":21},"2026-01-01",{"date":73,"type":21},"2028-03-01",{"name":75,"class":76},"Hospices Civils de Lyon","OTHER",1]