[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638580":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":37,"centralContacts":41,"locations":46,"responsibleParty":68,"collaborators":12,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":12,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":12,"enrollmentInfo":80,"targetDuration":12,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":92,"overallStatus":110,"whyStopped":12,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"University of Texas Southwestern Medical Center","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Component 1: CA Monitoring and EVD Clamping Validation","NO_INTERVENTION","All enrolled aSAH patients. Multimodal CA monitoring (B4C extensometry, NIRS-derived indices, invasive ICP\u002FCPP from EVD where present) throughout ICU Days 1-14. Participants with open EVDs additionally undergo a standardized 15-minute EVD clamping sub-protocol for simultaneous invasive\u002Fnoninvasive CA index validation, up to one session per 24-hour period. No interventional procedures administered under Component 1.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Component 2: Autonomic Modulation (CSB and taVNS)","EXPERIMENTAL","Component 1 participants meeting Component 2 eligibility criteria after PI readiness declaration. Receive right-sided cervical sympathetic block (CSB; ultrasound-guided, C6) and transcutaneous auricular vagal nerve stimulation (taVNS; cymba conchae, TENS 7000; twice daily 20-minute sessions for up to 14 days). Within-subject before-after assessment of CA parameter effects. CA monitoring from Component 1 continues throughout.",[18,19],"Procedure: Right-Sided Cervical Sympathetic Block at C6","Device: Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Right-Sided Cervical Sympathetic Block at C6","Ultrasound-guided right-sided cervical sympathetic block targeting pre-ganglionic cervical sympathetic fibers at the C6 level using low-volume ropivacaine. Real-time ultrasound guidance with aspiration prior to injection. Continuous cardiac monitoring throughout. Coagulation parameters confirmed within 24 hours of each procedure. Expected transient ipsilateral Horner syndrome lasting 2-6 hours.",[14],[27,28],"Stellate Ganglion Block","Cervical Sympatholysis",{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Transcutaneous Auricular Vagal Nerve Stimulation (taVNS)","Noninvasive vagal augmentation delivered via electrode placed at the cymba conchae of the right ear using the TENS 7000 device. Parameters: 25 Hz, 200-500 microamps, 200 microsecond pulse width; 20-minute sessions twice daily for up to 14 days (maximum 28 sessions). Continuous cardiac telemetry required; immediate device removal if HR falls below 50 bpm. Intensity set below pain threshold based on participant comfort feedback.",[14],[35,36],"Auricular Vagus Nerve Stimulation","TENS 7000",[38],{"name":39,"affiliation":5,"role":40},"Noah Jouett, DO, PhD","PRINCIPAL_INVESTIGATOR",[42],{"name":39,"role":43,"phone":44,"phoneExt":12,"email":45},"CONTACT","2147862783","Noah.Jouett@UTSouthwestern.edu",[47],{"facility":48,"status":12,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":60},"UT Southwestern Medical Center - Clements University Hospital NSICU","Dallas","Texas","75390","United States","US",{"type":55,"coordinates":56},"Point",[57,58],-96.80667,32.78306,{"lat":58,"lon":57},[61,62,63,66],{"name":39,"role":43,"phone":44,"phoneExt":12,"email":45},{"name":39,"role":40,"phone":12,"phoneExt":12,"email":12},{"name":64,"role":65,"phone":12,"phoneExt":12,"email":12},"Ulrike Hoffmann, MD, PhD","SUB_INVESTIGATOR",{"name":67,"role":65,"phone":12,"phoneExt":12,"email":12},"DaiWai Olson, PhD, RN",{"type":40,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Noah Jouett","Principal Investigator, Department of Anesthesiology and Pain Management","100638580","noninvasive-ca-monitoring-validation-and-autonomic-modulation-in-aneurysmal-subarachnoid-hemorrhage-100638580",false,"NCT07577739","Noninvasive CA Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage","Non-Invasive Cerebral Autoregulation Monitoring Validation and Autonomic Modulation in Aneurysmal Subarachnoid Hemorrhage: A Two-Component Prospective Study of EVD Clamping Validation, CA Natural History, and the Effects of Cervical Sympathetic Block and Transcutaneous Auricular Vagal Nerve Stimulation on Cerebral Autoregulation Parameters","Inclusion Criteria (Component 1 - All Enrolled Participants):\n\n* Age 18 years or older\n* Primary diagnosis of aneurysmal subarachnoid hemorrhage (aSAH), confirmed by imaging\n* Admitted to the NSICU at Clements University Hospital, UT Southwestern Medical Center\n* Informed consent obtained from subject or legally authorized representative (as defined under Texas Health and Safety Code Section 166.039)\n* Brain4Care extensometry sensor placeable at an appropriate cranial site not occluded by surgical dressings or EVD hardware\n* Open EVD with active continuous ICP monitoring (required for EVD clamping sub-protocol only; not required for Aims 2 or 3)\n\nExclusion Criteria (Component 1):\n\n* Age younger than 18 years\n* Prisoner status\n* Primary NSICU admission diagnosis other than aSAH\n* Active declination by subject or legally authorized representative\n* Brain4Care sensor not placeable at any accessible cranial site\n* Active clinical deterioration making research monitoring impractical at time of approach\n* Physician-of-record declining research enrollment for clinical reasons\n* Inability to provide informed consent in English\n* Known pregnancy at time of enrollment\n\nAdditional Inclusion Criteria for Component 2 (Aim 3 - CSB and taVNS):\n\n* At least one successful EVD clamping session completed\n* PI documentation of Component 2 operational readiness, co-signed by qualified co-investigator or Department Director\n* INR 1.5 or less and platelet count 50,000\u002FuL or greater within 24 hours prior to each CSB procedure\n* No active infection or cellulitis at right anterolateral neck\n* No known allergy to ropivacaine or amide local anesthetics\n* No contralateral phrenic nerve palsy or severe pre-existing respiratory compromise\n* No cardiac pacemaker or implanted cardiac device contraindicating taVNS\n* No allergy to electrode adhesive materials\n* Continuous cardiac telemetry active and interpretable\n* Resting HR 60 bpm or greater on two readings within 24 hours prior to session\n* No current use of Class I or III antiarrhythmic medications\n* No clinically significant AV conduction abnormality\n\nAdditional Exclusion Criteria for Component 2:\n\n* Prior ipsilateral right-sided cervical surgery, radiation, or known anatomical distortion precluding safe C6 approach\n* Hemodynamic instability with active vasopressor escalation at time of planned CSB\n* Active uncontrolled tachyarrhythmia or bradyarrhythmia at time of taVNS session\n* Physician-of-record declining autonomic modulation procedures for any clinical reason\n* Known or suspected pregnancy","ALL","18 Years",{"count":81,"type":82},300,"ESTIMATED","INTERVENTIONAL",[85],"NA","This is a two-component prospective study of adult aneurysmal subarachnoid hemorrhage (aSAH) patients admitted to the Neurosciences Intensive Care Unit (NSICU) at UT Southwestern Medical Center. Component 1 (active upon IRB approval) validates Brain4Care (B4C) extensometry-derived noninvasive cerebral autoregulation (CA) indices against invasive ICP-derived equivalents in aSAH patients with open external ventricular drains (EVDs), and characterizes the prospective natural history of multi-modal CA parameter evolution through the delayed cerebral ischemia (DCI) window (admission through Day 14). Component 2 (activated upon PI readiness declaration) assesses the within-subject effect of cervical sympathetic block (CSB) and transcutaneous auricular vagal nerve stimulation (taVNS) on CA parameters in enrolled aSAH patients.",[88,89,90,91],"Subarachnoid Hemorrhage, Aneurysmal","Delayed Cerebral Ischemia","Cerebral Vasospasm","Autonomic Nervous System Diseases",[93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109],"aneurysmal subarachnoid hemorrhage","delayed cerebral ischemia","cerebral autoregulation","CPPopt","MAPopt","pressure reactivity index","Brain4Care","cervical sympathetic block","stellate ganglion block","transcutaneous auricular vagal nerve stimulation","taVNS","autonomic modulation","EVD clamping","external ventricular drain","near-infrared spectroscopy","noninvasive ICP monitoring","neurocritical care","NOT_YET_RECRUITING","2026-05-04",{"date":113,"type":114},"2026-05-11","ACTUAL",{"date":116,"type":82},"2026-07",{"date":118,"type":82},"2030-06",{"name":5,"class":6},1]