[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100639248":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":41,"responsibleParty":77,"collaborators":26,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":26,"enrollmentInfo":89,"targetDuration":26,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":101,"overallStatus":44,"whyStopped":26,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Northwestern University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"tcVNS Stimulation (Intervention)","ACTIVE_COMPARATOR","Transcutaneous vagal nerve stimulation (tcVNS)",[13],"Device: Transcutaneous vagal nerve stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham tcVNS stimulation (Control)","SHAM_COMPARATOR","Sham transcutaneous vagal nerve stimulation (Sham tcVNS)",[19],"Device: Sham (No Treatment)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Transcutaneous vagal nerve stimulation","The tcVNS device utilized in this study is not an implanted device, but rather is solely operated outside of the body by affixing it around the patient's ear. The device delivers stimulation of the vagus nerve at designated intensity, interval, and frequency.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham (No Treatment)","The stimulator is flipped upside down so that the participant does not receive stimulation of the vagal nerve.",[15],[32],{"name":33,"affiliation":5,"role":34},"Charles Hogue, MD","PRINCIPAL_INVESTIGATOR",[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Jordan Wood, BS","CONTACT","3126950915","jordan.wood1@northwestern.edu",[42],{"facility":43,"status":44,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Northwestern University Feinberg School of Medicine","RECRUITING","Chicago","Illinois","60611","United States","US",{"type":51,"coordinates":52},"Point",[53,54],-87.65005,41.85003,{"lat":54,"lon":53},[57,59,63,64,67,69,71,73,75],{"name":37,"role":38,"phone":58,"phoneExt":26,"email":40},"312-695-0915",{"name":60,"role":38,"phone":61,"phoneExt":26,"email":62},"Bin Zhang, MS","312-695-7771","bin.zhang1@northwestern.edu",{"name":33,"role":34,"phone":26,"phoneExt":26,"email":26},{"name":65,"role":66,"phone":26,"phoneExt":26,"email":26},"Ravindra A Gupta, MD","SUB_INVESTIGATOR",{"name":68,"role":66,"phone":26,"phoneExt":26,"email":26},"John Bebawy, MD",{"name":70,"role":66,"phone":26,"phoneExt":26,"email":26},"Eyal Kimchi, MD, PhD",{"name":72,"role":66,"phone":26,"phoneExt":26,"email":26},"Jacqueline Morano, MD",{"name":74,"role":66,"phone":26,"phoneExt":26,"email":26},"Jamie Uejima, MD",{"name":76,"role":66,"phone":26,"phoneExt":26,"email":26},"Kimberly Klafta, MD",{"type":34,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Charles Hogue","James E. Eckenhoff Professor, Chair, Department of Anesthesiology","100639248","effects-of-transcutaneous-vagal-nerve-stimulation-on-post-surgical-return-to-consciousness-delirium-and-depression-100639248",false,"NCT07610655","Effects of Transcutaneous Vagal Nerve Stimulation on Post-Surgical Return to Consciousness, Delirium, and Depression","tVNS","Inclusion Criteria:\n\n1. Aged \\> 18 years of age\n2. Patients undergoing lumbar surgery for degenerative disc disease or spinal stenosis involving two or more levels\n3. Montreal Cognitive Assessment (MoCA) score ≥ 18 - accept mild\n4. Ability to use a keyboard\n5. Able to understand and communicate in English\n6. Be able to consent independently\n7. Women of child-bearing age must be comfortable confirming a negative pregnancy prior to participating in the study.\n8. Must not be involved in any other research intervention study testing neurobehavioral functioning\n\nExclusion Criteria:\n\n1. Age \\\u003C 18 years of age\n2. History of vagotomy (cutting the vagus nerve)\n3. History of bradycardia, heart block, prolonged QT syndrome, brugada syndrome, heart failure with ejection fraction less than 35% and\u002For New York Heart Association symptoms\n4. MoCA \\\u003C 18\n5. History of seizure disorder or intracranial hemorrhage\n6. Patients with carotid stenosis\n7. Patients with aneurysms\n8. Other neurological diagnoses or a diagnosis of severe psychiatric disorder (e.g., psychosis) or a reported childhood learning disability\n9. Pregnancy, breastfeeding\n10. Active addiction history\n11. ECG adhesive allergy\n12. Severe aphasia, preventing subject from understanding the protocol and giving written consent\n13. Patients will be excluded postoperatively if there is neck swelling at the proposed site of left tcVNS.","ALL","18 Years",{"count":90,"type":91},40,"ESTIMATED","INTERVENTIONAL",[94],"NA","This study will examine whether noninvasive, transcutaneous vagal nerve stimulation (tcVNS) can help restore consciousness in patients in the operating room and the Post Anesthesia Care Unit (PACU). The study will also investigate if tcVNS can expedite discharge from the PACU and examine whether tcVNS administerd in the PACU helps reduce delirium and depression after surgery. The study will also evaluate whether tcVNS speeds cognitive recovery from emergence of anesthesia and surgery.",[97,98,99,100],"Post Operative Delirium","Cognitive Impairment","Vagus Nerve Stimulation","Depression",[102,103,104,99,105,106,100,107],"Anesthesia Care","Post Anesthesia Care","Post Surgical Care","Delirium","Cognitive Imparment","Hospital Length of Stay","2026-05-26",{"date":110,"type":111},"2026-05-28","ACTUAL",{"date":113,"type":111},"2026-04-23",{"date":115,"type":91},"2029-05-31",{"name":5,"class":6},1]