[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579669":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":35,"responsibleParty":65,"collaborators":25,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":74,"eligibilityCriteria":75,"healthyVolunteers":70,"sex":76,"minAge":77,"maxAge":25,"enrollmentInfo":78,"targetDuration":25,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Campus Bio-Medico University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Real t-VNS","EXPERIMENTAL","real t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.",[13],"Device: Non Invasive vagus nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham t-VNS","ACTIVE_COMPARATOR","sham t-VNS on left ear for 40 minutes, daily for 3 consecutive days, simultaneously with speech therapy.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Non Invasive vagus nerve stimulation","Transcutaneous Auricular Vagus Nerve Stimulation",[9,15],null,[27,32],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Fioravante Capone, PhD","CONTACT","06225411220","f.capone@policlinicocampus.it",{"name":33,"role":29,"phone":25,"phoneExt":25,"email":34},"Fabio Pilato, MD","f.pilato@policlinicocampus.it",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Università Campus Bio-Medico di Roma","RECRUITING","Roma","RM","00128","Italy","IT",{"type":45,"coordinates":46},"Point",[47,48],11.10642,44.99364,{"lat":48,"lon":47},[51,55,57,59,61,63],{"name":52,"role":29,"phone":53,"phoneExt":25,"email":54},"Vincenzo Di Lazzaro","+3906225411220","v.dilazzaro@unicampus.it",{"name":28,"role":56,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":33,"role":58,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"name":60,"role":58,"phone":25,"phoneExt":25,"email":25},"Vitaliana Luccarelli",{"name":62,"role":58,"phone":25,"phoneExt":25,"email":25},"Chiara Grattarola",{"name":64,"role":58,"phone":25,"phoneExt":25,"email":25},"Davide Norata, MD",{"type":56,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Di Lazzaro Vincenzo","Prof","100579669","transcutaneous-auricular-vagus-nerve-stimulation-for-treating-post-stroke-dysphagia-100579669",false,"NCT06827301","Transcutaneous Auricular Vagus Nerve Stimulation for Treating Post-stroke Dysphagia","Transcutaneous Auricular Vagus Nerve Stimulation Combined With Rehabilitation Therapy for the Treatment of Post-stroke Dysphagia","LOGIC","Inclusion Criteria:\n\n* Acute ischemic or hemorrhagic stroke (within 7 days of onset)\n* Dysphagia diagnosed by FEES with a Fiberoptic Endoscopic Dysphagia Severity Scale (FEDSS) score between 3 and 5\n\nExclusion criteria:\n\n* Pre-existing stroke dysphagia\n* Dementia or other medical conditions that may interfere with the study","ALL","18 Years",{"count":79,"type":80},30,"ESTIMATED","INTERVENTIONAL",[83],"NA","The aim of the present project is to use transcutaneous auricular vagus nerve stimulation (t-VNS) for the treatment of dysphagia in acute stroke patients to improve swallowing function and reduce mortality and disability related to this condition.\n\n30 patients will be randomized into one of the two arms of the study:\n\n* REAL: real t-VNS + speech therapy\n* SHAM: t-VNS placebo + speech therapy. The experimental treatment consists in the association between t-VNS (real or placebo) and speech therapy exercises to improve swallowing functionality. Each patient will undergo a speech therapy rehabilitation session lasting approximately 40 minutes a day for 3 consecutive days, simultaneously with t-VNS on left ear.\n\nSwallowing function and clinical conditions will be evaluated before the intervention (baseline, T0), immediately after the intervention (T1) and 3 months after the intervention (T2).",[86],"Dysphagia Following Cerebrovascular Accident",[88,89,90],"vagus nerve stimulation","dysphagia","stroke","2025-02-10",{"date":93,"type":94},"2025-02-14","ACTUAL",{"date":96,"type":94},"2024-11-23",{"date":98,"type":80},"2026-06",{"name":5,"class":6},1]