[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100496728":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":84,"collaborators":26,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":26,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":26,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":52,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Istituti Clinici Scientifici Maugeri SpA","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"relapsing-remitting multiple sclerosis","ACTIVE_COMPARATOR","Patients with relapsing-remitting multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.",[13,14,15],"Diagnostic Test: quantification of sensory and autonomic small nerve fibers by punch skin biopsy","Diagnostic Test: Cardiovascular Reflexes testing","Other: Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms",{"label":17,"type":10,"description":18,"interventionNames":19},"primary progressive multiple sclerosis","Patients with primary progressive multiple sclerosis will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment and will perform a functional and morphological study of sensory and autonomic nervous system, evaluation of peripheral sensory and autonomic nerve fibers performed by skin biopsy.",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIAGNOSTIC_TEST","quantification of sensory and autonomic small nerve fibers by punch skin biopsy","We'll perform a punch skin biopsy of 3mm from thigh, leg and fingertip and we'll quantify peripheral sensory and autonomic nerve fibers.",[17,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Cardiovascular Reflexes testing","Cardiovascular reflex tests including deep breathing, head-up Tilt, standing, isometric exercises, mental arithmetic and Valsalva maneuver.",[17,9],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Administration of clinical scales evaluating autonomic symptoms, pain small fiber neuropathy symptoms","We'll characterize patients' symptoms through the administration of clinical scales such as: COMPASS 31 autonomic symptoms scale; Small Fiber Neuropathy Symptom Inventory Questionnaire (SFN-SIQ), the Pain Detect Questionnaire and the Total neuropathy score",[17,9],[36],{"name":37,"affiliation":38,"role":39},"Vincenzo Provitera, MD","ICS MAUGERI - IRCCS TELESE TERME","PRINCIPAL_INVESTIGATOR",[41,45],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},"CONTACT","+390824909257","vincenzo.provitera@icsmaugeri.it",{"name":46,"role":42,"phone":47,"phoneExt":26,"email":48},"Giuseppe Caporaso","+390824909645","giuseppe.caporaso@icsmaugeri.it",[50,66],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"ICS Maugeri - IRCCS of Telese Terme","RECRUITING","Telese Terme","Benevento","82037","Italy","IT",{"type":59,"coordinates":60},"Point",[61,62],14.52681,41.21752,{"lat":62,"lon":61},[65],{"name":37,"role":42,"phone":43,"phoneExt":26,"email":44},{"facility":67,"status":52,"city":68,"state":26,"zip":69,"country":56,"countryCode":57,"cosmosGeoPoint":70,"geoPoint":74,"contacts":75},"Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples Federico II","Naples","80131",{"type":59,"coordinates":71},[72,73],14.26811,40.85216,{"lat":73,"lon":72},[76,80],{"name":77,"role":42,"phone":78,"phoneExt":26,"email":79},"Fiore Manganelli, MD","+0817462666","fiore.manganelli@unina.it",{"name":81,"role":42,"phone":82,"phoneExt":26,"email":83},"Rosa Iodice, MD","+39081746266","rosa.iodice@unina.it",{"type":85,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100496728","definition-of-autonomic-nervous-system-involvement-in-patients-with-multiple-sclerosis-100496728",false,"NCT05748015","Definition of Autonomic Nervous System Involvement in Patients With Multiple Sclerosis","Definition of Autonomic Nervous System Involvement in Patients With Relapsing-remitting and Primary Progressive Multiple Sclerosis","Inclusion Criteria:\n\n* diagnosis of relapsing-remitting and primary progressive multiple sclerosis.\n\nExclusion Criteria:\n\n* other forms of multiple sclerosis,\n* known other neurological disorders\n* assumption of potentially neurotoxic substances or drugs.","ALL","18 Years",{"count":96,"type":97},60,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this interventional non-pharmacological study is to evaluate the involvement of the autonomic nervous system in patients with relapsing-remitting and primary progressive multiple sclerosis.\n\nThe main questions it aims to answer are:\n\n* Is it possible to define the characteristics of dysautonomia to improve treatment on patients with multiple sclerosis through the management of conditions such as orthostatic hypotension or thermoregulation disorders that inevitably condition the patient's life and the response to rehabilitation ?\n* Does the severity of the functional alterations correlate with impairment of small somatic and autonomic cutaneous nerve fibers in patients with multiple sclerosis ?\n* How much the involvement of the autonomic nervous system affects the clinical history and progression of the disease ?\n* Do different clinical variants of multiple sclerosis manifest with different patterns of involvement of the sensory-autonomic nervous system ?\n\nParticipants will be hospitalized in Maugeri Clinical Institute of Telese Terme for a rehabilitation treatment. Patients will perform a sensory and autonomic functional study and a morphological analysis of cutaneous nerves through skin biopsy.\n\nResearchers will compare results between the two groups (relapsing-remitting and primary progressive) and between patients and data from control subjects.",[103],"Multiple Sclerosis",[105,106,107,108],"autonomic nervous system","sensory nervous system","rehabilitation","skin biopsy","2026-04-14",{"date":111,"type":112},"2026-04-17","ACTUAL",{"date":114,"type":112},"2021-03-04",{"date":116,"type":97},"2027-05-30",{"name":5,"class":6},2]