[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100532224":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":29,"responsibleParty":50,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":10,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":31,"whyStopped":10,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"130",null,"Patients with diagnosis of DRE and DSE will be recruited among patients who are regularly followed at our Epilepsy Outpatients Service (OSR). The diagnosis of DRE and DSE focal cryptogenic epilepsy will be based on the most recent sets of criteria of different types of epilepsy. A small group of NDE patients will be also enrolled\n\nA population of 30 focal cryptogenic epilepsy patients diagnosed with DRE (drug resistant epilepsy) A population of 90 focal cryptogenic epilepsy patients diagnosed with DRE (drug sensitive epilepsy) 10 patients newly diagnosed for focal cryptogenic epilepsy (NDE) will be recruited too.",[13],"Diagnostic Test: Neuropsychological Assessment",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DIAGNOSTIC_TEST","Neuropsychological Assessment","Cognitive evaluation and clinical monitoring of seizure frequency",[9],[21,26],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Anna Bellini, MD","CONTACT","+390226432154","bellini.anna@hsr.it",{"name":27,"role":23,"phone":24,"phoneExt":10,"email":28},"Davide Gusmeo Curti, MD","curti.davide@hsr.it",[30],{"facility":5,"status":31,"city":32,"state":10,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"RECRUITING","Milan","20132","Italy","IT",{"type":37,"coordinates":38},"Point",[39,40],9.18951,45.46427,{"lat":40,"lon":39},[43,47],{"name":44,"role":23,"phone":45,"phoneExt":10,"email":46},"Massimo Filippi, MD","00390226433054","filippi.massimo@hsr.it",{"name":48,"role":23,"phone":49,"phoneExt":10,"email":25},"Anna A. Bellini, MD","00390226432154",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Prof. Massimo Filippi","Professor Massimo Filippi","100532224","cognitive-impairment-in-drug-resistant-and-drug-responsive-focal-cryptogenic-epilepsy-100532224",false,"NCT06210022","Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy","Cognitive Impairment in Drug-resistant and Drug-responsive Focal Cryptogenic Epilepsy: a Longitudinal Observational Study","Inclusion Criteria:\n\n* Inclusion criteria for all study subjects:\n\n  * monolingual native Italian speakers;\n  * age between 18-60 years;\n  * normal or corrected-to-normal visual acuity;\n  * oral and written informed consent to study participation.\n  * if assuming psychotropic drugs (i.e., benzodiazepines, antipsychotics, antidepressants), they should be at stable dosage for more than 4 weeks.\n* Inclusion criteria for DRE patients:\n\n  * diagnosis of focal cryptogenic epilepsy;\n  * previous failure of at least 2 anti-seizure medication (ASM at adequate dose;\n  * at least 3 seizures in the last 2 months; • available brain MRI (\\\u003C5 years).\n* Inclusion criteria for DSE patients:\n\n  * diagnosis of focal cryptogenic epilepsy;\n  * seizure control obtained after not more than 2 ASM;\n  * seizure freedom for at least 6 months;\n  * available brain MRI (\\\u003C5 years).\n* Inclusion criteria for NDE patients:\n\n  * new diagnosis of focal cryptogenic epilepsy (\\\u003C3 months)\n  * not more than 1 ASM tested\n  * available brain MRI (\\\u003C3 months)\n\nExclusion Criteria:\n\n* Age\\> 60 years;\n* Documented developmental delay;\n* Evidence of focal abnormalities at neuroimaging (except of hippocampal sclerosis);\n* Neurological degenerative conditions;\n* history of other systemic (including systemic neoplasms in the last 3 years and abnormal hepatorenal functions), neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations;\n* alcohol and\u002For psychotropic drugs abuse","ALL","18 Years","60 Years",{"count":65,"type":66},130,"ESTIMATED","12 Months","OBSERVATIONAL","This is a national monocentric (San Raffaele Hospital - OSR, Via Olgettina, 60, 20132 Milan, Italy) observational low-risk-intervention study, prospective and multiparametric (clinical, EEG, neuropsychological evaluations) study.\n\nPatients with a diagnosis of DRE and DSE will be screened to evaluate their eligibility. They will undergo clinical and cognitive assessments in addition to 32channel EEG at baseline (T0). DRE patients will also undergo clinical and cognitive assessments, and 32-channel EEG at 6 months (T1), and 12 months (T2). Patients newly diagnosed with focal cryptogenic epilepsy (NDE) will undergo clinical and cognitive assessments, and 32-channel EEG at baseline (T0), at 6 months (T1), and 12 months (T2).\n\nHigh-definition EEG will be performed to investigate patterns of cortical sources and functional connectivity alteration specific to DRE and DSE and to explore their prognostic value. Longitudinal EEGs will be acquired to explore the evolution of EEG patterns.\n\nCognitive evaluation will be performed by an experienced neuropsychologist. At baseline, DRE, DSE, and NDE patients will undergo a screening and a comprehensive cognitive battery in order to define performance differences among groups. The DRE and NDE group only will perform the same neuropsychological assessment at month 6 and 12 for monitoring the potential progression of cognitive and\u002For behavioural disturbances in these patients.",[71,72],"Epilepsy","Focal Epilepsy",[74,75,76],"epilepsy","focal cryptogenic epilepsy","drug resistant epilepsy","2024-06-20",{"date":79,"type":80},"2024-06-24","ACTUAL",{"date":77,"type":80},{"date":83,"type":66},"2027-03-01",{"name":5,"class":6},1]