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โ† Trials
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Transcutaneous Auricular Vagus Nerve Stimulation for Recovery of Consciousness After Surgery for Spontaneous Intracerebral Hemorrhage

RecruitingNAAges 18 Years - 75 YearsAllBeijing Tiantan Hospital
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In plain words

What the trial is, and whether it could suit you

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. This 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 (

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Spontaneous intracerebral hemorrhage. * Age 18 to 75 years. * Surgical intervention performed within 48 hours after symptom onset. * 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. * Surgical hematoma evacuation by craniotomy, endoscopic evacuation, or minimally invasive aspiration/fragmentation. * Written informed consent provided by the participant's legally authorized representative. Exclusion Criteria: * โ€ข Intracranial hemorrhage caused by a confirmed intracranial aneurysm, cerebral vascular malformation, intracranial tumor, arterial thrombosis, or venous thrombosis. * Injury to critical brain structures affecting consciousness, including brainstem hemorrhage or thalamic hemorrhage greater than 20 mL. * Isolated intraventricular hemorrhage. * Severe cardiomyopathy, heart failure, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or another severe cardiac arrhythmia. * Unstable postoperative vital signs, defined as systolic blood pressure below 90 mm Hg or heart rate below 50 beats per minute. * New cerebral infarction or recurrent intracranial hemorrhage between surgery and randomization. * Acute myocardial ischemia or myocardial infarction between surgery and randomization. * 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. * Skin breakdown, infection, erythema, or another condition at the electrode-placement site that makes taVNS unsuitable. * Pregnant, peripartum, or postpartum women. * Current participation in another clinical trial.
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What it tests

  • Active Transcutaneous Auricular Vagus Nerve Stimulation
  • Sham Transcutaneous Auricular Vagus Nerve Stimulation
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Where

1 site
Capital Medical University Affliated Beijing Tiantan Hospital, Beijing, Beijing
Beijing, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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