[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651410":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":54,"collaborators":58,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":40,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Beijing Tiantan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Active taVNS","EXPERIMENTAL","Participants receive active transcutaneous auricular vagus nerve stimulation at the left ear for 8 hours once daily for 6 weeks, in addition to standard postoperative and rehabilitation care.",[13],"Device: Active Transcutaneous Auricular Vagus Nerve Stimulation",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham taVNS","SHAM_COMPARATOR","Participants wear the same taVNS device with the electrode placed at the same left-ear location for 8 hours once daily for 6 weeks, but no electrical current is delivered. Standard postoperative and rehabilitation care is otherwise provided.",[19],"Device: Sham Transcutaneous Auricular Vagus Nerve Stimulation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Active Transcutaneous Auricular Vagus Nerve Stimulation","Active taVNS is delivered to the left ear at a frequency of 25 Hz, a pulse width of 500 microseconds, and a current intensity of 0.8-1.5 mA. Stimulation alternates between 30 seconds on and 30 seconds off for a total wearing period of 8 hours once daily. Treatment begins after randomization on postoperative day 5 (±1 day) and continues for 6 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Sham Transcutaneous Auricular Vagus Nerve Stimulation","The sham device is worn at the same left-ear location and for the same schedule as active taVNS (8 hours once daily for 6 weeks), but no electrical current is delivered.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Qingyuan Liu, M.D.","CONTACT","+86-13260457220","13260457220@163.com",[38],{"facility":39,"status":40,"city":41,"state":26,"zip":26,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Capital Medical University Affliated Beijing Tiantan Hospital, Beijing, Beijing","RECRUITING","Beijing","China","CN",{"type":45,"coordinates":46},"Point",[47,48],116.39723,39.9075,{"lat":48,"lon":47},[51,52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"name":53,"role":34,"phone":26,"phoneExt":26,"email":26},"Shuo Wang, M.D.",{"type":55,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Wang Shuo","Director of Department of Cerebrovascular Neurosurgery",[59,61,63],{"name":60,"class":6},"Beijing Friendship Hospital",{"name":62,"class":6},"First Affiliated Hospital of Fujian Medical University",{"name":64,"class":6},"Liaocheng People's Hospital","100651410","transcutaneous-auricular-vagus-nerve-stimulation-for-recovery-of-consciousness-after-surgery-for-spontaneous-intracerebral-hemorrhage-100651410",false,"NCT07761507","Transcutaneous Auricular Vagus Nerve Stimulation for Recovery of Consciousness After Surgery for Spontaneous Intracerebral Hemorrhage","Efficacy and Mechanisms of Transcutaneous Auricular Vagus Nerve Stimulation for Promoting Recovery of Consciousness After Surgery for Spontaneous Intracerebral Hemorrhage: A Multicenter, Prospective, Double-Blind, Randomized, Sham-Controlled Trial","TAVNS-SICH","Inclusion Criteria:\n\n* Spontaneous intracerebral hemorrhage.\n* Age 18 to 75 years.\n* Surgical intervention performed within 48 hours after symptom onset.\n* Glasgow Coma Scale score of 5 to 9 on postoperative day 5 while the participant is not sedated; for intubated participants, the verbal component is scored as 1T.\n* Surgical hematoma evacuation by craniotomy, endoscopic evacuation, or minimally invasive aspiration\u002Ffragmentation.\n* Written informed consent provided by the participant's legally authorized representative.\n\nExclusion Criteria:\n\n* • Intracranial hemorrhage caused by a confirmed intracranial aneurysm, cerebral vascular malformation, intracranial tumor, arterial thrombosis, or venous thrombosis.\n\n  * Injury to critical brain structures affecting consciousness, including brainstem hemorrhage or thalamic hemorrhage greater than 20 mL.\n  * Isolated intraventricular hemorrhage.\n  * Severe cardiomyopathy, heart failure, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or another severe cardiac arrhythmia.\n  * Unstable postoperative vital signs, defined as systolic blood pressure below 90 mm Hg or heart rate below 50 beats per minute.\n  * New cerebral infarction or recurrent intracranial hemorrhage between surgery and randomization.\n  * Acute myocardial ischemia or myocardial infarction between surgery and randomization.\n  * Previous vagus nerve electrical stimulation, previous cervical vagotomy, concurrent use of another stimulation device, or presence of an implanted electronic medical device, including a muscle stimulator, cardiac pacemaker, hearing aid, or any other implanted electronic device.\n  * Skin breakdown, infection, erythema, or another condition at the electrode-placement site that makes taVNS unsuitable.\n  * Pregnant, peripartum, or postpartum women.\n  * Current participation in another clinical trial.","ALL","18 Years","75 Years",{"count":77,"type":78},160,"ESTIMATED","INTERVENTIONAL",[81],"NA","Disorders of consciousness are common after surgery for severe spontaneous intracerebral hemorrhage and are associated with high mortality, disability, and long-term dependence. Transcutaneous auricular vagus nerve stimulation (taVNS) is a noninvasive neuromodulation technique that may enhance arousal-network activity, modulate secondary brain injury, and promote recovery of consciousness.\n\nThis multicenter, prospective, double-blind, randomized, sham-controlled trial will enroll 160 adults aged 18 to 75 years who underwent hematoma evacuation within 48 hours after spontaneous intracerebral hemorrhage and have a Glasgow Coma Scale score of 5 to 9 on postoperative day 5 while not sedated. Participants will be assigned 1:1 to active taVNS or sham stimulation for 8 hours once daily for 6 weeks. The primary outcome is the proportion of participants who remain in a disorder of consciousness (unresponsive wakefulness syndrome\u002Fvegetative state or minimally conscious state) at postoperative day 90, determined using the Coma Recovery Scale-Revised by blinded assessors.\n\nNested mechanistic substudies will investigate how taVNS may affect recovery through multimodal assessment of structural and functional brain networks, cerebral perfusion, electrophysiology, autonomic function, and circulating or cerebrospinal-fluid biomarkers. Depending on clinical stability, site capability, sample availability, and additional consent, assessments may include computed tomography, computed tomography angiography and perfusion, structural and functional magnetic resonance imaging, diffusion imaging, arterial spin labeling, electroencephalography, blood samples, and cerebrospinal fluid obtained during clinically indicated procedures.",[84,85],"Disorders of Consciousness","Spontaneous Intracerebral Hemorrhage",[87,88,89,90,91],"Spontaneous intracerebral hemorrhage","Postoperative disorder of consciousness","Transcutaneous auricular vagus nerve stimulation","Recovery of consciousness","Coma Recovery Scale-Revised","2026-08-11",{"date":94,"type":95},"2026-08-12","ACTUAL",{"date":97,"type":78},"2026-08",{"date":99,"type":78},"2027-12",{"name":5,"class":6},1]