[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579272":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":48,"collaborators":11,"id":50,"slug":51,"hasResults":52,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":52,"sex":58,"minAge":59,"maxAge":11,"enrollmentInfo":60,"targetDuration":11,"studyType":63,"phases":64,"briefSummary":66,"conditions":67,"keywords":11,"overallStatus":72,"whyStopped":11,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Rheinburg-Klinik","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VNS group","EXPERIMENTAL",null,[13],"Device: transcutaneous auricular vagus nerve stimulation",{"label":15,"type":16,"description":11,"interventionNames":17},"control group","SHAM_COMPARATOR",[18],"Device: sham-stimulation",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","transcutaneous auricular vagus nerve stimulation","Stimulation parameters:\n\n* Stimulating side: ipsilateral to the infarcted brain hemisphere\n* Location of pStimulation: Cymba conchae\n* Impulse shape: bi-phasic\n* Impulse intensity: at least 0.5 mA (max. 2.0 mA).\n* Impulse duration: 28 sec on, 32 sec off\n* Impulse frequency: 20-30 Hz.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"sham-stimulation","An electrode is only attached to the ear without applying electrical impulses.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Felix Fluri, PD Dr. med.","CONTACT","+41 58 511 70 01","felix.fluri@kliniken-valens.ch",[36],{"facility":37,"status":11,"city":38,"state":11,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":11,"geoPoint":11,"contacts":42},"Rheinburg Klinik","Walzenenhausen","9824","Switzerland","CH",[43,45],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":44},"felix.fluri@gmx.ch",{"name":46,"role":47,"phone":11,"phoneExt":11,"email":11},"Katharina Kreiger, MSc, MSc","SUB_INVESTIGATOR",{"type":49,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100579272","effect-of-vagus-nerve-stimulation-via-the-outer-ear-on-motor-and-cognitive-deficits-after-ischemic-stroke-100579272",false,"NCT06822140","Effect of Vagus Nerve Stimulation Via the Outer Ear on Motor and Cognitive Deficits After Ischemic Stroke","Effect of Transcutaneous Auricular Vagus Nerve Stimulation on Motor and Cognitive Deficits After Ischemic Stroke","EVAMOS","Inclusion Criteria:\n\n* Onset of stroke ≥15 days and ≤30 days after randomization\n* Ischemic stroke in the anterior cerebral circulation detected by MR imaging or computer tomography\n* National Institutes of Health Stroke Scale (NIHSS) score ≥3 points\n* Montreal Cognitive Assessment (MoCA) score ≤ 26 points\n* First ever stroke\n* Right-handed\n* Ability to participate in a standardized rehabilitation therapy\n* Written informed consent signed by the subject or next kin\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Pregnant and breastfeeding women\n* Severe concomitant neurological (brain tumor, encephalitis, Parkinson disease, epilepsy prior to stroke onset) or mental disorders (psychiatric conditions such as schizophrenia, uncontrolled depression or bipolar disorder before stroke onset)\n* Severe aphasia (i.e. unable to follow two-stage-commands)\n* Pre-existing hemiparesis\n* Documented history of dementia before index stroke\n* Primary intracranial hematoma or subarachnoid hemorrhage\n* Active implantable medical device (e.g., pacemaker, deep brain stimulator, cochlear implants, cerebral shunts)\n* Metal cervical spine hardware or metallic implant near the stimulation site\n* Modified Rankin scale (mRS) ≥ 2 prior to stroke onset\n* Low heart rate (\\\u003C 60 bpm)\n* Severe vision and hearing problems\n* Alcohol and drug abuse\n* Active post-stroke delirium, unable to cooperate\n* Type 1 and 2 diabetes mellitus\n* Sore and diseased skin of the auricle\n* Patients receiving any therapy (medication or otherwise) at study entry that would interfere with VNS","ALL","18 Years",{"count":61,"type":62},144,"ESTIMATED","INTERVENTIONAL",[65],"NA","The goal of this clinical trial is to learn if transcutaneous auricular vagus nerve stimulation (taVNS) works to treat motor and neurocognitive deficits after ischemic stroke when applied within 30 days after onset of stroke.\n\nThe main questions it aims to answer are:\n\n* Does tVNS improve motor deficits measured by the Fugl-Mayer assessment after ischemic stroke?\n* Does tVNS ameliorate stroke-related cognitive impairment? Researchers will compare tVNS to a placebo (sham stimulation, i.e. an electrode is fixed on the ear without applying electrical impulses ) to see if tVNS works to treat motor and cognitive deficits after stroke .\n\nParticipants will:\n\n* Receive tVNS or sham stimulation for 30 minutes 5 days a week during 5 weeks after ischemic stroke\n* Receive smotor and cognitive training during the tVNS or sham stimulation\n* Will take part on a standardized stroke rehabilitation program during the 5 weeks in a rehabilitation clinic.",[68,69,70,71],"Ischemic Stroke","Motor Deficits","Cognitive Impairment","Vagus Nerve Stimulation","NOT_YET_RECRUITING","2025-02-16",{"date":75,"type":76},"2025-02-19","ACTUAL",{"date":78,"type":62},"2025-04-01",{"date":80,"type":62},"2028-04-30",{"name":5,"class":6},1]