Noninvasive ear vagus nerve stimulation for acute intracerebral hemorrhage

Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Acute Intracerebral Hemorrhage

This trial will test whether gentle electrical stimulation of the ear (taVNS) can reduce swelling around a recent intracerebral hemorrhage in adults treated within 72 hours of symptom onset.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 186 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Beijing Tiantan Hospital (Academic / other)
• Locations: 1 site (Beijing, Beijing Municipality)
• Trial ID: NCT06918964 on ClinicalTrials.gov

What this trial studies

This is a randomized, sham-controlled trial enrolling 186 adults with spontaneous supratentorial intracerebral hemorrhage who present within 72 hours. Participants are randomized 1:1 to active transcutaneous auricular vagus nerve stimulation (taVNS) delivered with the BS-TVNS800-1 device or to a sham device. The primary outcome is the relative volume of perihematomal edema measured on days 10–14 after randomization, and safety is monitored by systematic recording of adverse events. Key inclusion criteria include age 18–80, hematoma volume 5–40 mL, and Glasgow Coma Scale >8, while secondary causes of hemorrhage, large intraventricular extension, planned imminent surgery, severe cardiac disease, pacemaker, or pre-existing major disability are excluded.

Who should consider this trial

Good fit: Adults aged 18–80 with spontaneous supratentorial ICH who present within 72 hours, have hematoma volume 5–40 mL, and a GCS greater than 8 are the intended participants.

Not a fit: Patients with secondary causes of hemorrhage, large intraventricular extension, planned urgent surgery, severe cardiomyopathy or pacemaker, or pre-existing major disability (mRS ≥3) are unlikely to be eligible or to benefit from this intervention.

Why it matters

Potential benefit: If successful, taVNS could shrink perihematomal edema after ICH and potentially improve neurological recovery and functional outcomes.

How similar studies have performed: Preclinical work and small clinical studies of vagus nerve stimulation suggest anti-inflammatory effects, but using taVNS specifically for acute ICH is novel and not yet proven in large trials.

Eligibility criteria

Inclusion Criteria:

1. Patients with spontaneous supratentorial intracerebral hemorrhage.
2. Age between 18 and 80 years.
3. Onset within 72 hours.
4. Hematoma volume between 5 and 40 mL.
5. Glasgow Coma Scale (GCS) score greater than 8.
6. Written informed consent obtained from the patient or their legal representative.

Exclusion Criteria:

1. Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
2. Primary intraventricular hemorrhage.
3. Parenchymal hemorrhage that ruptures into the ventricles, with blood completely filling one lateral ventricle, the third ventricle, the fourth ventricle or more than half of both lateral ventricles.
4. Progressive neurological or other severe diseases.
5. Planned surgical treatment within 24 hours.
6. Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
7. Patients with severe cardiomyopathy, heart failure, pacemaker implantation, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or other severe arrhythmias.
8. Severe pulmonary disease, liver disease, renal insufficiency (glomerular filtration rate \< 30 mL/min), active gastrointestinal bleeding, or malignant tumors with an expected survival of less than 3 months.
9. Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
10. Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) within 7 days before screening.
11. Patients who cannot tolerate taVNS.
12. Congenital or acquired ear abnormalities preventing taVNS treatment.
13. Inability to comply with 10 days of treatment.
14. Pregnancy or within 30 days of delivery.
15. Participation in another interventional clinical trial.
16. Inability to obtain written informed consent from the participant or their legal representative.

Where this trial is running

Beijing, Beijing Municipality

• Beijing Tiantan Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Recruiting)

Conditions Intracerebral Hemorrhage; taVNS; perihemtomal edema; neuroinflammation; secondary brain injury