[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"epilepsies-focal\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:epilepsies-focal":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100306407","impact-of-epileptic-discharge-on-the-structural-connectivity-of-the-developing-brain-100306407",false,"NCT03268824","Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain","Impact of Epileptic Discharge on the Structural Connectivity of the Developing Brain: Combination of Intracerebral Stereotactic Electroencephalography Recording and Diffusion Tensor Imaging in Children With Drug-resistant Focal Epilepsy","EPITRACT","Inclusion Criteria:\n\n\\- Drug resistant focal epilepsy\n\nInclusion Criteria for control patients:\n\n\\- without drug resistant focal epilepsy\n\nExclusion Criteria:\n\n* Severe mental retardation (IQ \\\u003C 50)\n* Lack of French-language skills\n* Contraindications to MRI\n* Bi-hemispherical epilepsy or affecting multiple lobes\n\nExclusion Criteria for control patients:\n\n* Severe mental retardation (IQ \\\u003C 50)\n* Lack of French-language skills\n* Contraindications to MRI\n* Congenital pathology altering cerebral connectivity\n* Parenchymal brain lesions\n* Unilateral or bilateral blindness\n* Unilateral or bilateral deafness\n* Autistic disorders","ALL","18 Months","16 Years",{"count":21,"type":22},82,"ESTIMATED","OBSERVATIONAL","Focal epilepsy is associated with widespread alterations in structural brain connectivity, often present at the disease onset and related to learning disabilities. Whether ongoing seizure activity contributes to network pathology is a matter of debate. This study intends to measure the impact of seizures on structural connectivity on a local and on a global level. In children examined with intracerebral electrodes to evaluate whether a surgical cure can be proposed, we combine intracerebral stereotactic electroencephalography (EEG) recordings with diffusion weighted imaging of white matter fibers. On the local level, the study will quantify the number of deficient connections in the seizure onset zone. On a global level, the study will compare the white matter fibers of the left and right hemisphere to probe whether physiological language lateralization is preserved.",[26,27,28],"Epilepsies, Focal","Pediatrics","Drug Resistant Epilepsy","RECRUITING","2025-12-30",{"date":32,"type":33},"2026-01-05","ACTUAL",{"date":35,"type":33},"2017-12-19",{"date":37,"type":22},"2026-07",{"name":39,"class":40},"Fondation Ophtalmologique Adolphe de Rothschild","NETWORK",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":17,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":75},"100581868","home-ultra-long-term-eeg-monitoring-for-rare-epilepsies-and-developmental-and-epileptic-encephalopathies-100581868","NCT06855901","Home Ultra-long Term EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies","Home Ultra-longterm EEG Monitoring for Rare Epilepsies and Developmental and Epileptic Encephalopathies. an Open Label Nonpharmacological Interventional Prospective Study by Means of Minimally Invasive Wearable EEG Device","EMIRE","Inclusion Criteria:\n\n* Age \\> 12 years old, with or without intellectual disabilities;\n* Diagnosis of drug resistant seizures, DEE or rare epilepsies ;\n* One or more seizure types as established by previous epilepsy history thus allowing to define seizure type and scalp topography of the ictal discharge;\n* Availability for the duration of the study (3 months);\n\nExclusion Criteria:\n\n* Subjects with psychiatric disorders including schizophrenia, bipolar affective disorder, emotionally unstable personality disorder, schizoaffective disorder;\n* Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement;\n* Subject has an infection at implant site;\n* Subjects at high risk of surgical complications, such as active systemic infection and hemorrhagic disease;\n* Subject has or is exposed to a medical device that delivers electrical energy into the area around the implant (cochlear implant(s));\n* Subject has a profession or hobby that includes activity imposing an unacceptable risk for trauma to the device or implant site, e.g. martial arts or boxing;\n* Subject has a contraindication to the use of local anesthetic drugs used during implantation- and removal of the device;\n* Subject is unable or does not have the necessary assistance to properly operate the device system.\n* Pregnancy","12 Years",{"count":52,"type":22},30,"INTERVENTIONAL",[55],"NA","With this study the Investigator expects to develop a precise patient-centered model of care by means of home ultra-long-term EEG monitoring with a minimally invasive wearable EEG device (sqEEG).\n\nThe following aims will be pursued:\n\n1. to assess the sensitivity, reliability, and safety of sqEEG to record seizures over prolonged periods;\n2. to verify sensitivity and reliability of automated seizure detection algorithms and to assess circadian and ultradian seizure\u002Finterictal epileptic discharges; distribution for the development of personalized seizure action plan;\n3. to evaluate whether data collected with sqEEG can improve the clinical management of the patients and treatment outcomes.\n\nThe investigator expects to use this wearable at-home EEG device to obtain an objective quantification of electrographic and electro-clinical seizures over a twelve-week period up to twenty-four weeks at home. The precise quantification of seizures is essential for a tailored treatment approach and to effectively monitor the response to treatment adjustments.\n\nThe potential innovation of this approach relies on the possibility of managing the patient at home, reducing the side effects related to hospitalization and objectively quantifying the disease burden in the real-life setting with the aim of improve globally the patients' quality of life.",[58,26,59],"Epilepsies","Epileptic Encephalopathy",[61,62,63,64],"Epilepsy","Epileptic encephalopathies","subscalp EEG","Ultra-long EEG monitoring","2025-02-27",{"date":67,"type":33},"2025-03-04",{"date":69,"type":33},"2024-01-17",{"date":71,"type":22},"2026-12-30",{"name":73,"class":74},"Azienda Ospedaliero-Universitaria di Modena","OTHER",4]