[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559306":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":10,"centralContacts":26,"locations":36,"responsibleParty":53,"collaborators":55,"id":58,"slug":10,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":71,"studyType":72,"phases":10,"briefSummary":73,"conditions":74,"keywords":78,"overallStatus":39,"whyStopped":10,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"IRCCS National Neurological Institute \"C. Mondino\" Foundation","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Responders",null,"Patients with high frequency episodic or chronic migraine undergoing treatment with monoclonal antibodies directed against calcitonin gene related peptide pathway (mAbs) who obtained a reduction in monthly migraine days equal or higher than 50% compared to pre-treatment values.",[13],"Drug: MAbs",{"label":15,"type":10,"description":16,"interventionNames":17},"NON-Responders","Patients with high frequency episodic or chronic migraine undergoing mAbs treatment who obtained a reduction in monthly migraine days \\\u003C 50% compared to pre-treatment values.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","MAbs","Monthly or quarterly mAbs administration",[15,9],[25],"Monoclonal antibody targeting the CGRP pathway (ligand or receptor) (mAbs)",[27,32],{"name":28,"role":29,"phone":30,"phoneExt":10,"email":31},"Roberto De Icco","CONTACT","00390382380425","roberto.deicco@mondino.it",{"name":33,"role":29,"phone":34,"phoneExt":10,"email":35},"Cinzia Fattore","00390382380385","cinzia.fattore@mondino.it",[37],{"facility":38,"status":39,"city":40,"state":10,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Headache Science & Neurorehabilitation Unit","RECRUITING","Pavia","27100","Italy",{"type":44,"coordinates":45},"Point",[46,47],9.15917,45.19205,{"lat":47,"lon":46},[50],{"name":51,"role":29,"phone":52,"phoneExt":10,"email":31},"Roberto De Icco, Prof","00382380425",{"type":54,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[56],{"name":57,"class":6},"University of L'Aquila","100559306",false,"NCT06562413","Searching for Novel Biological Phenotypes in Migraine Patients Resistant to Treatments","Unraveling the Spectrum of Migraine Resistant to Treatments: Searching for Novel Biological PHEnotypes and theRApeutic Approaches (SPHERA Project)","SPHERA_WP1_2","Inclusion Criteria:\n\n* male and female patients aged 18 to 75 years\n* diagnosis of episodic migraine or chronic migraine according to ICHD-3 criteria\n* for episodic migraine: 8-14 monthly migraine days in the previous 3 months\n* diagnosis of resistant migraine, defined by having failed at least 3 classes of migraine preventatives and suffer from at least 8 debilitating monthly headache days for at least 3 consecutive months\n* patients naive to CGRP targeting treatments\n\nExclusion Criteria:\n\n* history of major psychiatric or other neurological conditions\n* diagnosis of other primary or secondary headache disorders (only sporadic tension-type headache is allowed if the patients can clearly differentiate between the 2 types of headaches)\n* changes in ongoing preventive treatment (if any) in the previous 3 months\n* clinically significant medical conditions\n* chronic pain conditions\n* alcohol and\u002For drug abuse\n* pregnancy or lactation","ALL","18 Years","75 Years",{"count":69,"type":70},100,"ESTIMATED","6 Months","OBSERVATIONAL","The investigators aim to define the neurofunctional phenotype of migraine patients who did not respond to at least 3 preventive treatments, including monoclonal antibodies (mAbs) targeting calcitonin gene-related peptide (CGRP) pathway (NON-responders).\n\nPrimary aim will be to assess and compare changes in functional resting-state connectivity at baseline and after three months of mAbs treatment between patients who will achieve a reduction of monthly migraine days \\>\u002F= than 50% (namely Responders) and those who will not (namely Responders).\n\nThe 2 groups will undergo a neurofunctional profile by means of High Density-electroencephalogram (HD-EEG) and functional-magnetic resonance imaging (fMRI).",[75,76,77],"Migraine Disorders","Chronic Migraine","Episodic Migraine",[79,80,81,82,83,84],"migraine","anti CGRP mABs","calcitonin gene related peptide","HD EEG","functional MRI","brain connectivity","2024-08-17",{"date":87,"type":88},"2024-08-20","ACTUAL",{"date":90,"type":88},"2023-05-10",{"date":92,"type":70},"2026-05",{"name":5,"class":6},1]