NCT07761507 Transcutaneous Auricular Vagus Nerve Stimulation for Recovery of Consciousness After Surgery for Spontaneous Intracerebral Hemorrhage
| NCT ID | NCT07761507 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Disorders of Consciousness |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2026-08 |
| Primary Completion | 2027-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2026-08 with a primary completion date of 2027-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 (unresponsive wakefulness syndrome/vegetative state or minimally conscious state) at postoperative day 90, determined using the Coma Recovery Scale-Revised by blinded assessors. Nested 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.
Eligibility Criteria
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: * • 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07761507 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Disorders of Consciousness. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07761507 currently recruiting?
Yes, NCT07761507 is actively recruiting participants. Contact the research team at 13260457220@163.com for enrollment information.
Where is the NCT07761507 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07761507 clinical trial?
NCT07761507 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 160 participants.