[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100523781":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":26,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":26,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":26,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.","ACTIVE_COMPARATOR","Subjects will be randomized to receive the active device on the day of surgery.\n\nSubjects will receive treatment according to the following time points:\n\n* Pre-operative: 30 minutes in the hour prior to surgery\n* Intra-operative: 30 minutes before the end of surgery\n* Post-operative: 30 minutes at 3 and 6 hours after surgery\n* Inpatient: Four 30-minute sessions on Day 2",[13],"Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham tAN + standard of care (SOC) for post-operative pain management for lumbar spine patients.","PLACEBO_COMPARATOR","Subjects will be randomized to receive the sham device on the day of surgery.\n\nSubjects will receive treatment according to the following time points:\n\n* Pre-operative: 30 minutes in the hour prior to surgery\n* Intra-operative: 30 minutes before the end of surgery\n* Post-operative: 30 minutes at 3 and 6 hours after surgery\n* Inpatient: Four 30-minute sessions on Day 2",[19],"Device: Sham Control Device",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)","This method of simultaneous vagal and trigeminal stimulation via the external ear is known as transcutaneous auricular neurostimulation (tAN), as the targets of electrical stimulation include the auricular branch of the vagus nerve (ABVN) and auriculotemporal nerve (ATN), which is a branch of the mandibular division of the trigeminal nerve. Electrodes applied to select dermatome regions can target ear neural structures and deliver non-invasive vagus nerve stimulation (VNS) and trigeminal nerve stimulation (TNS). Use of tAN for pain relief is an attractive alternative to pharmacologic and opioid-based approaches because it is safe and effective and presents no addiction liability.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Control Device","This device looks like the active device, but no stimulation will be delivered.",[15],[32],{"name":33,"affiliation":5,"role":34},"Alex Valadka, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","214-645-2300","alex.valadka@utsouthwestern.edu",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Tyfe Oderinde, MS","214-648-9905","Bolutyfe.Oderinde@utsouthwestern.edu",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":54,"coordinates":55},"Point",[56,57],-96.80667,32.78306,{"lat":57,"lon":56},[60,61],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},{"type":34,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Alex Valadka","Professor","100523781","transcutaneous-auricular-neurostimulation-after-lumbar-surgery-100523781",false,"NCT06100172","Transcutaneous Auricular Neurostimulation After Lumbar Surgery","Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery","Inclusion Criteria:\n\n1. Medically cleared to undergo a lumbar spine surgery, either spinal fusion with or without multilevel laminectomies, or lumbar multilevel laminectomies alone.\n2. 18-85 years of age\n3. English Proficiency\n4. Participants must be able to provide informed consent and function at an intellectual level sufficient for study requirements\n\nExclusion Criteria:\n\n1. Current evidence of an uncontrolled and\u002For clinically significant medical condition\n2. History of bleeding disorders or coagulopathy\n3. History of seizures or epilepsy\n4. History of neurological diseases or traumatic brain injury\n5. Use of illegal recreational drugs\n6. Presence of devices, e.g. pacemakers, cochlear prosthesis, neuro-stimulators\n7. Use of acupuncture within 4 weeks of surgery\n8. Grossly abnormal external ear anatomy or active ear infection\n9. Women of childbearing potential, not using effective contraception per investigator judgment or not willing to comply with contraception for the duration of the study\n10. Females who are pregnant or lactating\n11. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial","ALL","18 Years","85 Years",{"count":76,"type":77},20,"ESTIMATED","INTERVENTIONAL",[80],"NA","The purpose of this study, entitled \"Delivering Transcutaneous Auricular Neurostimulation as an Adjunct Non-Opioid Pain Management Therapy for Patients Undergoing Lumbar Surgery\", is to demonstrate whether transcutaneous auricular neurostimulation (tAN) can non-invasively reduce the perception of pain in patients undergoing lumbar surgery. tAN is placed on and around the ear to non-invasively stimulate branches of the vagus and trigeminal nerves and modulate specific brain regions associated with pain.",[83,84,85],"Pain, Postoperative","Opioid Use","Lumbar Spine Injury",[87,88],"Lumbar Surgery","Transcutaneous auricular neurostimulation (tAN)","2025-12-05",{"date":91,"type":92},"2025-12-15","ACTUAL",{"date":94,"type":92},"2024-10-29",{"date":96,"type":77},"2027-12",{"name":5,"class":6},1]