Status:
RECRUITING
TaVNS for Acute Intracerebral Hemorrhage
Lead Sponsor:
Beijing Tiantan Hospital
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
Brief Summary
This study aims to evaluate the efficacy and safety of transcutaneous auricular vagus nerve stimulation (taVNS) in patients with acute intracerebral hemorrhage (ICH). The taVNS intervention will be de...
Eligibility Criteria
Inclusion
- Patients with spontaneous supratentorial intracerebral hemorrhage.
- Age between 18 and 80 years.
- Onset within 72 hours.
- Hematoma volume between 5 and 40 mL.
- Glasgow Coma Scale (GCS) score greater than 8.
- Written informed consent obtained from the patient or their legal representative.
Exclusion
- Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
- Primary intraventricular hemorrhage.
- 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.
- Progressive neurological or other severe diseases.
- Planned surgical treatment within 24 hours.
- Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
- Patients with severe cardiomyopathy, heart failure, pacemaker implantation, atrial fibrillation, frequent premature beats, second-degree or higher atrioventricular block, or other severe arrhythmias.
- 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.
- Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
- Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) within 7 days before screening.
- Patients who cannot tolerate taVNS.
- Congenital or acquired ear abnormalities preventing taVNS treatment.
- Inability to comply with 10 days of treatment.
- Pregnancy or within 30 days of delivery.
- Participation in another interventional clinical trial.
- Inability to obtain written informed consent from the participant or their legal representative.
Key Trial Info
Start Date :
September 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT06918964
Start Date
September 15 2025
End Date
December 1 2028
Last Update
September 19 2025
Active Locations (1)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100070