[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100552024":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":56,"collaborators":20,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":20,"enrollmentInfo":69,"targetDuration":20,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Determine the effect of tAN on serum concentrations of inflammatory mediators in TBI patients","EXPERIMENTAL","Subjects will receive treatment upon providing informed consent and will undergo transcutaneous auricular neurostimulation (tAN) once daily during their ICU stay, with the treatment duration not exceeding 10 days. Two blood samples will be collected daily: one before the tAN session and another two hours after the session. Participant data will be collected daily throughout the ICU stay. Additionally, surveys will be collected from registered nurses providing direct care to TBI patients enrolled in the tAN-TBI study to assess the compatibility of tAN with patient care processes in the ICU.",[13],"Device: Sparrow Ascent Transcutaneous Auricular Neurostimulation (tAN)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"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).",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Alex Valadka, MD","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","2146452300","alex.valadka@utsouthwestern.edu",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Aisha Qureshi","2146489905","Aisha.Qureshi@UTSouthwestern.edu",[35],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"UT Southwestern Medical Center","RECRUITING","Dallas","Texas","75390","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-96.80667,32.78306,{"lat":47,"lon":46},[50,52],{"name":23,"role":27,"phone":51,"phoneExt":20,"email":29},"214-645-2300",{"name":53,"role":27,"phone":54,"phoneExt":20,"email":55},"Tyfe Oderinde, MS","214-648-9905","bolutyfe.oderinde@utsouthwestern.edu",{"type":24,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Alex Valadka","Professor","100552024","transcutaneous-auricular-neurostimulation-for-icu-patients-with-traumatic-brain-injury-100552024",false,"NCT06467708","Transcutaneous Auricular Neurostimulation for ICU Patients With Traumatic Brain Injury","Delivering Transcutaneous Auricular Neurostimulation (tAN) to ICU Patients With Traumatic Brain Injury (tAN-TBI)","tAN-TBI","Inclusion Criteria:\n\n1. Post-resuscitation GCS score 12 or below and acute trauma-related intradural blood on head CT scan after TB\n2. Age 18 years or older (pediatric trauma patients are not routinely transported to Parkland)\n3. Consent from legally authorized representative\n\nExclusion Criteria:\n\n1. Hemodynamic instability\n2. Expected imminent mortality because of overwhelming neurological and\u002For systemic injury\n3. Unclear neurological status because of paralytic medications or intoxication with ethanol or other drugs\n4. Presence of other electrical stimulation devices (pacemaker, cochlear prosthesis, neurostimulator, etc.)\n5. Abnormal ear anatomy or ear infection\n6. Participant is pregnant or lactating\n7. Any other significant medical or psychosocial problems that, in the opinion of the investigator, would potentially cause harm to the participant, impact their ability to participate, or influence the results of the trial","ALL","18 Years",{"count":70,"type":71},42,"ESTIMATED","INTERVENTIONAL",[74],"NA","The overarching goal of this pilot study is to assess the feasibility and safety of transcutaneous auricular neurostimulation (tan) in ICU patients with TBi and to determine the effect of tan on serum markers of inflammation. exploratory analyses will examine effects on such physiological parameters as blood pressure, heart rate, and intracranial pressure (iCP), as well as measures of neurological function.",[77],"TBI (Traumatic Brain Injury)",[79],"Transcutaneous auricular neurostimulation (tAN)","2026-02-16",{"date":82,"type":83},"2026-02-18","ACTUAL",{"date":85,"type":83},"2025-02-11",{"date":87,"type":71},"2027-02-11",{"name":5,"class":6},1]