TaVNS for Acute Intracerebral Hemorrhage (TAVANS-ICH)

Capital Medical University

Status: Enrolling

Conditions: Intracerebral Hemorrhage

Treatments: Device: transcutaneous auricular vagus nerve stimulation device; Device: Sham device

Study type: Interventional

Funder types: Other

Identifiers

NCT06918964

KangKJ

Details and patient eligibility

About

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 delivered using the BS-TVNS800-1 transcutaneous electrical stimulation therapy device (KERFUN, Shanxi, China). A total of 186 patients will be randomly assigned in a 1:1 ratio to either the taVNS group or the sham-taVNS group. The primary outcome is the relative volume of perihematoma edema assessed on day 10-14 after randomization. Adverse events associated with taVNS therapy will be systematically evaluated to assess its safety profile.

Enrollment: 186 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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186 participants in 2 patient groups

taVNS intervention

Active Comparator group

Description:

Patients will receive taVNS therapy twice daily for 10 consecutive days, in addition to receiving guideline-adherent conventional treatment during hospitalization.

Treatment:

Device: transcutaneous auricular vagus nerve stimulation device

Sham taVNS intervention

Sham Comparator group

Description:

Patients will receive sham taVNS twice daily for 10 consecutive days, in addition to receiving guideline-adherent conventional treatment during their hospital stay.

Treatment:

Device: Sham device