[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517699":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":10,"centralContacts":10,"locations":53,"responsibleParty":70,"collaborators":73,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":10,"eligibilityCriteria":86,"healthyVolunteers":87,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":94,"studyType":95,"phases":10,"briefSummary":96,"conditions":97,"keywords":10,"overallStatus":99,"whyStopped":10,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University of Catania","OTHER",[8,17,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Control",null,"Healthy patients",[13,14,15,16],"Diagnostic Test: TDI","Diagnostic Test: Trigeminal Test","Diagnostic Test: Visual Analogue Scale Ratings","Diagnostic Test: Quality of smell Questionnaire",{"label":18,"type":10,"description":19,"interventionNames":20},"Multiple Sclerosis 1","Patients with multiple Sclerosis and Trigeminal disorders",[13,14,21,22,15,16],"Diagnostic Test: Cognitive Evaluation by Montreal Cognitive Assessment","Diagnostic Test: Anxiety and Depression questionnaire",{"label":24,"type":10,"description":25,"interventionNames":26},"Multiple Sclerosis 2","Patients with Multiple Sclerosis without trigeminal concerns",[13,14,21,22,15,16],[28,33,37,41,45,49],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":10},"DIAGNOSTIC_TEST","TDI","Sniffin' Sticks Threshold and Identification Test",[9,18,24],{"type":29,"name":34,"description":35,"armGroupLabels":36,"otherNames":10},"Trigeminal Test","Test the trigeminal smell answer by a device that releases air and a substance that stimulates the trigeminal response",[9,18,24],{"type":29,"name":38,"description":39,"armGroupLabels":40,"otherNames":10},"Cognitive Evaluation by Montreal Cognitive Assessment","Montreal Cognitive assessment",[18,24],{"type":29,"name":42,"description":43,"armGroupLabels":44,"otherNames":10},"Anxiety and Depression questionnaire","Specific test to evaluate patient's mood",[18,24],{"type":29,"name":46,"description":47,"armGroupLabels":48,"otherNames":10},"Visual Analogue Scale Ratings","* Smell ability (How is your sense of smell right now? 0 cannot smell, 1-3 severe impairment, 4-6 moderate impairment, 7-9 mild impairment, 10 normal)\n* Nasal breathing (How well can you breathe through your nose right now? 0 complete nasal obstruction, 1-3 severe impairment, 4-6 moderate impairment, 7-9 mild impairment, 10 normal)",[9,18,24],{"type":29,"name":50,"description":51,"armGroupLabels":52,"otherNames":10},"Quality of smell Questionnaire","Patients will answer to a validated questionnaire",[9,18,24],[54],{"facility":55,"status":10,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Arianna Di Stadio","Catania","Sicily","95121","Italy","IT",{"type":62,"coordinates":63},"Point",[64,65],15.07041,37.49223,{"lat":65,"lon":64},[68],{"name":55,"role":69,"phone":10,"phoneExt":10,"email":10},"CONTACT",{"type":71,"investigatorFullName":55,"investigatorTitle":72,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Associate Professor (temporary)",[74,76,78],{"name":75,"class":6},"University of Roma La Sapienza",{"name":77,"class":6},"Hospital General Universitario Santa Lucia",{"name":79,"class":6},"Klinik und Poliklinik fur Kinderheilkunde","100517699","olfactory-and-trigeminal-functions-in-patients-with-multiple-sclerosis-case-control-study-100517699",false,"NCT06020937","Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis: Case-control Study","Olfactory and Trigeminal Functions in Patients With Multiple Sclerosis","Inclusion Criteria:\n\nAdult women (age 18 to 55) diagnosed with multiple sclerosis using the 2017 McDonald Criteria under treatment with Disease Modifying Therapy (DMTs) with or without trigeminal concerns, or newly diagnosed with MS\n\nExclusion Criteria:\n\n* Chronic rhinosinusitis with and without nasal polyposis; current allergic rhinitis; other nasal issues that lead to olfactory dysfunction\n* anamnestic COVID with incomplete recovery\n* Neurodegenerative disorders (Parkinson, Alzheimer, Fronto-temporal Dementia, cognitive impairment and brain vascular diseases)\n* History of stroke in the last three years\n* Depression or any psychiatric condition\n* intake of drugs with sedating side effects\n* major health issues that might affect olfactory function (e.g., significant renal insufficiency, uncontrolled diabetes)\n* Chronic alcoholism \u002F drug abuse\n* Severe head trauma\n* Severe facial injuries\n* Smoker over 20 cigarettes day or smoking from more than 15 years",true,"FEMALE","18 Years","55 Years",{"count":92,"type":93},200,"ESTIMATED","12 Months","OBSERVATIONAL","The sensation of smell is influenced by the somatosensory and chemesthetic sensati¬ons of the nose: for example, the cooling sensation of menthol or the prickle of carbon dioxide from carbonated drinks. These sensations are mediated in the nose by the trigeminal nerve and there is increasing evidence that trigeminal and olfactory functions are closely linked and potentially interdependent. In addition, trigeminal activation is crucial to the perception of nasal airflow. Some researchers speculate about the impact of trigeminal nerve on the entire olfactory sensation and about the presence of some specific \"trigeminal cells\" into the nose.Patients with Multiple sclerosis (MS) can suffer from quantitative olfactory disorders that generally are of light entity and do not interfere with daily life activities but it is important to underline that olfactory loss can be an onset sign of the MS. Considering the \"trigeminal component\" in the olfaction, because trigeminal nerve inflammation is quite common in MS patients due to central and peripheral inflammation, it could be possible that these patients suffer from changes in the quantitative, but more in the qualitative smell functions that are generally not identified because poorly investigated.",[98],"Multiple Sclerosis","NOT_YET_RECRUITING","2026-05-11",{"date":102,"type":103},"2026-05-12","ACTUAL",{"date":105,"type":93},"2026-05-30",{"date":107,"type":93},"2028-12-30",{"name":5,"class":6},1]