[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100304267":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":48,"overallOfficials":65,"centralContacts":70,"locations":76,"responsibleParty":94,"collaborators":26,"id":97,"slug":26,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":26,"enrollmentInfo":107,"targetDuration":26,"studyType":110,"phases":26,"briefSummary":111,"conditions":112,"keywords":26,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"University of Giessen","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Dysphagia","Changes found in endoscopic swallowing study :\n\nPresence and severity of dysphagia (measured with Rosenbek's Penetration\u002FAspiration-scale)","96 hours after initial symptoms",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"Neuropsychological deficits","Agnosia, neglect",{"measure":18,"description":19,"timeFrame":12},"Lesion site","Side, vascular territory, swallowing relevant structures",{"measure":21,"description":22,"timeFrame":12},"Sensitivity","Sensitivity of faucial pillar region",{"measure":24,"description":25,"timeFrame":12},"Taste\u002FSmell","Smell-\u002FTaste-score",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"CASE_ONLY","PROSPECTIVE","Stroke is the second leading cause of death. At least 50% of stroke patients develop dysphagia, leading to aspiration pneumonia, which is the main cause of death in stroke \\[2\\].\n\nIt is assumed that normal sensitivity is vital for aspiration-free swallowing and for the triggering of the swallowing reflex.\n\nAli et al. demonstrated aspiration-free swallowing in healthy volunteers who underwent local anaesthesia of oral and pharyngeal structures \\[1\\]. Power et al. showed a reduced sensitivity of pharyngeal structures in stroke patients prone to aspiration \\[3\\].\n\nBy combining measuring sensitivity and flexible endoscopic swallowing studies, this study further investigates the role of sensitivity in swallowing Neuropsychological deficits of swallowing, such as swallowing apraxia or buccal hemineglect, is assessed by neuropsychological testing.\n\nAdditionally, there is no systematic research investigating the change in smell and taste in correlation with changes in stroke patients","Stroke patients are recruited in a university hospital's department of neurology.\n\nVolunteers \\>60years are recruited in a trauma surgery ward at the same university hospital.\n\nVolunteers \\\u003C60 are recruited without specified characteristics (aside from in-\u002Fexclusion criteria).",[33,39,42],{"label":34,"type":26,"description":35,"interventionNames":36},"Volunteers \u003C60 years","Volunteers, who are able to consent to participation in the study, as control.",[37,38],"Other: Sensitivity threshold","Diagnostic Test: Taste-\u002Fsmell-test",{"label":40,"type":26,"description":35,"interventionNames":41},"Volunteers >60 years",[37,38],{"label":43,"type":26,"description":44,"interventionNames":45},"Stroke patients","Stroke patients with supratentorial stroke, who are able to consent to participation in the study.",[46,37,38,47],"Diagnostic Test: FEES (flexible endoscopic evaluation of swallowing)","Diagnostic Test: Neuropsychological testing",[49,54,58,61],{"type":50,"name":51,"description":52,"armGroupLabels":53,"otherNames":26},"DIAGNOSTIC_TEST","FEES (flexible endoscopic evaluation of swallowing)","Endoscopical swallowing study in stroke patients only",[43],{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":26},"Sensitivity threshold","Determining sensitivity threshold using a pudendal electrode",[43,34,40],{"type":50,"name":59,"description":59,"armGroupLabels":60,"otherNames":26},"Taste-\u002Fsmell-test",[43,34,40],{"type":50,"name":62,"description":63,"armGroupLabels":64,"otherNames":26},"Neuropsychological testing","Neuropsychological testing for neglect, agnosia",[43],[66],{"name":67,"affiliation":68,"role":69},"Tobias Braun, M.D.","University Giessen","PRINCIPAL_INVESTIGATOR",[71],{"name":67,"role":72,"phone":73,"phoneExt":74,"email":75},"CONTACT","+49(0)-641-985","56827","tobias.braun@neuro.med.uni-giessen.de",[77],{"facility":78,"status":79,"city":80,"state":81,"zip":82,"country":83,"countryCode":84,"cosmosGeoPoint":85,"geoPoint":90,"contacts":91},"Universitätsklinikum Gießen","RECRUITING","Giessen","Hesse","35392","Germany","DE",{"type":86,"coordinates":87},"Point",[88,89],8.67554,50.58727,{"lat":89,"lon":88},[92],{"name":67,"role":72,"phone":93,"phoneExt":74,"email":75},"+49 641 985",{"type":69,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Tobias Braun","Principal Investigator","100304267",false,"NCT03240965","Changes in Sensitivity, Taste and Smell in Stroke Patients","Changes in Sensitivity of Swallowing-relevant Structures, Taste and Smell in Stroke Patients","5S","Inclusion Criteria:\n\nVolunteers:\n\n* informed consent\n\nStroke patients:\n\n* informed consent\n* new supratentorial stroke (\\\u003C72 hours old) confirmed by CT (computed tomography) or MRI (magnetic resonance imaging)\n\nExclusion Criteria:\n\n* pre-existing stroke oder dysphagia\n* extensive white matter lesions in CT- or MRI-scan\n* allergies to odorous substances or flavoring\n* contraindications for FEES (flexible endoscopic evaluation of swallowing), CT or MRI (stroke patients only)",true,"ALL","18 Years",{"count":108,"type":109},200,"ESTIMATED","OBSERVATIONAL","This study evaluates changes in swallowing using endoscopic swallowing studies and measuring of pharyngeal sensitivity, taste and smell in stroke patients. Younger (\\\u003C60 years) and older (\\>60 years) volunteers will serve as control.",[10,113],"Stroke","2023-11-30",{"date":116,"type":117},"2023-12-01","ACTUAL",{"date":119,"type":117},"2017-10-01",{"date":121,"type":109},"2026-12",{"name":5,"class":6},1]