[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558664":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":49,"centralContacts":54,"locations":49,"responsibleParty":64,"collaborators":49,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":49,"eligibilityCriteria":73,"healthyVolunteers":74,"sex":75,"minAge":76,"maxAge":49,"enrollmentInfo":77,"targetDuration":49,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":86,"overallStatus":91,"whyStopped":49,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":49},{"fullName":5,"class":6},"Columbia University","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Group +\u002F+","EXPERIMENTAL","Group +\u002F+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.",[13,14],"Device: Active transcranial direct current stimulation","Device: Active vagus nerve stimulation",{"label":16,"type":17,"description":18,"interventionNames":19},"Group +\u002F-","ACTIVE_COMPARATOR","Group +\u002F- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.",[13,20],"Other: Sham vagus nerve stimulation",{"label":22,"type":17,"description":23,"interventionNames":24},"Group -\u002F+","Group -\u002F+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.",[14,25],"Other: Sham transcranial direct current stimulation",{"label":27,"type":28,"description":29,"interventionNames":30},"Group -\u002F-","SHAM_COMPARATOR","Group -\u002F- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.",[25,20],[32,39,45,50],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":37},"DEVICE","Active transcranial direct current stimulation","Ten minutes of active transcranial direct current stimulation",[9,16],[38],"tDCS",{"type":33,"name":40,"description":41,"armGroupLabels":42,"otherNames":43},"Active vagus nerve stimulation","Ten minutes of active vagus nerve stimulation",[9,22],[44],"VNS",{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":49},"Sham transcranial direct current stimulation","Ten minutes of sham tDCS",[22,27],null,{"type":6,"name":51,"description":52,"armGroupLabels":53,"otherNames":49},"Sham vagus nerve stimulation","Ten minutes of sham VNS",[16,27],[55,60],{"name":56,"role":57,"phone":58,"phoneExt":49,"email":59},"Paul S. Garcia, MD PhD","CONTACT","212-304-7523","pg2618@cumc.columbia.edu",{"name":61,"role":57,"phone":62,"phoneExt":49,"email":63},"Oriana Lujan, MD","212-3047523","ol2274@cumc.columbia.edu",{"type":65,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":49,"oldOrganization":49},"PRINCIPAL_INVESTIGATOR","Paul Garcia","Associate Professor of Anesthesiology, Division Chief of Neuroanesthesia","100558664","effects-of-tdcs-and-vns-on-postoperative-analgesia-100558664",false,"NCT06554067","Effects of tDCS and VNS on Postoperative Analgesia","Inclusion Criteria:\n\n* Adults aged 18 years or above with the capacity to provide informed consent who are undergoing an elective surgery requiring general anesthesia\n\nExclusion Criteria:\n\n* cardiac bradyarrhythmia: taking beta-blockers;\n* patients with metal implants around the chest, neck, or head (e.g. implantable pacemakers and defibrillators, deep brain stimulation devices);\n* pregnancy\n* history of epilepsy or seizures.\n* patients undergoing surgical procedures involving the head, neck or spine, or those requiring the use of cardiopulmonary bypass",true,"ALL","18 Years",{"count":78,"type":79},200,"ESTIMATED","INTERVENTIONAL",[82],"NA","This study seeks to evaluate the efficacy of transcranial direct current stimulation (tDCS) and Afferent Vagus nerve simulation (VNS) in treating acute postoperative pain of patients in the post-anesthesia care unit after general surgery.\n\nStudy outcomes will include changes in pain levels and vital signs. For patients who are admitted after surgery, opioid consumption in the 24 hours after surgery and time from surgery to discharge are recorded as secondary outcomes.\n\nPatients will be divided in the following comparison groups:\n\n* Group +\u002F+ will receive ten minutes of active tDCS followed by ten minutes of active VNS.\n* Group +\u002F- will receive ten minutes of active tDCS followed by ten minutes of sham VNS.\n* Group -\u002F+ will receive ten minutes of sham tDCS followed by ten minutes of active VNS.\n* Group -\u002F- will receive ten minutes of sham tDCS followed by ten minutes of sham VNS.",[85],"Acute Postoperative Pain",[87,88,89,90],"Postoperative pain","Chronic Pain","Transcranial direct current stimulation","Vagus nerve stimulation","NOT_YET_RECRUITING","2024-08-12",{"date":94,"type":95},"2024-08-14","ACTUAL",{"date":97,"type":79},"2024-08",{"date":99,"type":79},"2026-08",{"name":5,"class":6}]