[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584872":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":40,"responsibleParty":75,"collaborators":77,"id":81,"slug":82,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":83,"sex":89,"minAge":90,"maxAge":91,"enrollmentInfo":92,"targetDuration":11,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":105,"overallStatus":110,"whyStopped":11,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"Fundación Cardiovascular de Colombia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy","EXPERIMENTAL",null,[13],"Device: Transcutaneous auricular vagus nerve stimulation + rehabilitation therapy",{"label":15,"type":16,"description":11,"interventionNames":17},"Sham stimulation + rehabilitation therapy","SHAM_COMPARATOR",[18],"Other: sham stimulation + rehabilitation therapy",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Transcutaneous auricular vagus nerve stimulation using INPULSE 3 times a week for six consecutive weeks. The stimulation parameters will be a frequency of 30Hz with a pulse width of 300 us and a stimulation time of 1.5 seconds for each respiratory cycle. The electrical current will be gradually increased to a maximum of 5 mA (0.25-mA increments) to allow adaptation to the stimulation until a comfortable tolerance level is achieved. Patients will receive physical rehabilitation therapy during stimulation, which will include reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"sham stimulation + rehabilitation therapy","Patients will receive physical rehabilitation therapy during placebo stimulation (No electrical stimulation), including reaching and grasping exercises, gross movements, turning objects, simulating specific tasks, inserting objects, opening and closing containers.",[15],[29],{"name":30,"affiliation":5,"role":31},"Sandra M Sanabria, Bacteriologist, PhD","STUDY_DIRECTOR",[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Nicolas Peña Novoa, Physiotherapist","CONTACT","(+57) 3008682154","nicolasnovoa2000@gmail.com",{"name":30,"role":35,"phone":11,"phoneExt":11,"email":39},"sandrasanabria@fcv.org",[41],{"facility":42,"status":11,"city":43,"state":44,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Neurology Center of Excellence - Hospital Internacional de Colombia - Fundación cardiovascular de Colombia","Piedecuesta","Santander Department","Colombia","CO",{"type":48,"coordinates":49},"Point",[50,51],-73.04953,6.98789,{"lat":51,"lon":50},[54,57,60,63,65,67,69,71,73],{"name":55,"role":35,"phone":56,"phoneExt":11,"email":37},"Nicolas Peña, Physiotherapist","3008682154",{"name":58,"role":59,"phone":11,"phoneExt":11,"email":11},"Tony F Álvarez, MD - Neurologist","PRINCIPAL_INVESTIGATOR",{"name":61,"role":62,"phone":11,"phoneExt":11,"email":11},"Ronald G Gómez, MD, MSc, PhD","SUB_INVESTIGATOR",{"name":64,"role":62,"phone":11,"phoneExt":11,"email":11},"Jorge A Ramos, Nurse, MSc, PhD",{"name":66,"role":62,"phone":11,"phoneExt":11,"email":11},"Sandra M Sanabria, Bacteriologist - PhD",{"name":68,"role":62,"phone":11,"phoneExt":11,"email":11},"Ligia C Rueda, MD - Psychiatrist",{"name":70,"role":62,"phone":11,"phoneExt":11,"email":11},"Federico A Silva, MD - Neurologist, MSc",{"name":72,"role":62,"phone":11,"phoneExt":11,"email":11},"Edwin O González, Electronic Engineer",{"name":74,"role":62,"phone":11,"phoneExt":11,"email":11},"Nicolas Peña, Phisiotherapist",{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[78],{"name":79,"class":80},"Ministerio de Ciencia Tecnología e Innovación - Minciencias","UNKNOWN","100584872","transcutaneous-auricular-vagus-nerve-stimulation-in-patients-with-stroke-100584872",false,"NCT06895005","Transcutaneous Auricular Vagus Nerve Stimulation in Patients With Stroke","Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation on Upper Limb Motor Recovery After Stroke","INPULSE","Inclusion Criteria:\n\n* Age \\>18 years and \\\u003C75 years\n* Unilateral supratentorial ischemic stroke that occurred at least 7 days but not more 30 days before enrollment.\n* Modified Rankin Scale between 0 and 1 before stroke\n* Contralesional UL motor impairment defined by NIHSS item 5 score ≥ 1 to ≤ 3.\n* Ability to provide written informed consent.\n* Hemodynamically stable patients.\n* Patients residing in the metropolitan area of Bucaramanga.\n\nExclusion Criteria:\n\n* Significant cognitive or language impairment that would interfere with study participation or informed consent. This criterion will be defined by NIHSS item 1a-c score \\> 2, item 9 score \\> 1, item 11 score = 2.\n* Medical conditions that could interfere with study participation, for example ear infections or skin wounds.\n* Bradycardia (\\\u003C 50 bpm) or hypotension (\\\u003C 90\u002F60 mmHg)\n* Significant pre-existing disability\n* History of stroke\n* History of cardiac arrhythmia\n* History of severe head trauma, brain surgery, deep brain stimulation, or brain injuries of other etiologies.\n* Pregnant or planning on becoming pregnant or breastfeeding during the study period.\n* Medical or mental instability (diagnosis of personality disorder, psychosis, or substance abuse) that would prevent subject from meeting protocol timeline.\n* Subjects who are currently in another clinical trial or plan to do so during the study period.\n* Patient receiving any therapy at study entry that would interfere with VNS (e.g., drugs that interfere with neurotransmitter mechanisms: anticholinergics, adrenergic blockers, etc.).\n* Prior injury to vagus nerve.\n* Any other implanted device such as a pacemaker or other neurostimulator; any other investigational device or drug.","ALL","18 Years","75 Years",{"count":93,"type":94},30,"ESTIMATED","INTERVENTIONAL",[97],"NA","This study will evaluate the effects of transcutaneous vagus nerve stimulation in combination with physical rehabilitation on upper limb motor function of patients with stroke.",[100,101,102,103,104],"Motor Impairment","Motor Impairments","Stroke","Stroke; Sequelae","Stroke, Ischemic",[102,106,107,108,109],"Vagus nerve","Vagus nerve stimulation","Transcutaneous vagus nerve stimulation","Rehabilitation","NOT_YET_RECRUITING","2025-03-25",{"date":113,"type":114},"2025-03-30","ACTUAL",{"date":116,"type":94},"2025-04-01",{"date":118,"type":94},"2025-12-24",{"name":5,"class":6},1]