TaVNS for Acute Intracerebral Hemorrhage

Launched by BEIJING TIANTAN HOSPITAL · Apr 7, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called transcutaneous auricular vagus nerve stimulation (taVNS) for people who have experienced an acute intracerebral hemorrhage, which is bleeding inside the brain. The goal is to see if this treatment can help reduce swelling around the bleeding area and improve recovery. In this study, 186 participants will be randomly divided into two groups: one will receive the taVNS treatment, while the other will receive a placebo, which is a sham treatment that looks like the real one but has no active effect.

To qualify for the trial, participants must be between 18 and 80 years old and have had a stroke caused by bleeding in the brain within the last 72 hours. They should also be alert enough to answer questions and give consent for participation. Throughout the study, participants will have their health monitored to ensure safety and gather information on how well the treatment is working. It’s important to note that certain medical conditions and treatments could exclude someone from joining the trial, so potential participants should discuss their eligibility with their healthcare provider.

Gender

ALL

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.