TaVNS for Acute Intracerebral Hemorrhage

NCT ID: NCT06918964

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2028-12-31

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 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.

Conditions

Intracerebral Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

taVNS intervention

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

Group Type: ACTIVE_COMPARATOR

transcutaneous auricular vagus nerve stimulation device

Intervention Type: DEVICE

Place the stimulation device on the left auricle and set the stimulation parameters according to the following conditions: a. Waveform: biphase, square wave; b. Wave width: 200 μs; c. Frequency: Alternating between low frequency (4 Hz for 4 s), high frequency (40 Hz for 8 s), and a 4 s pause; d. Intensity: The maximum intensity that induces the strongest sensation the individual can tolerate without causing pain, usually 1.5-3.5 mA; e. Treatment duration: Each treatment lasted 30 minutes, twice daily (8:00, 16:00) for 10 days.

Sham taVNS intervention

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

Group Type: SHAM_COMPARATOR

Sham device

Intervention Type: DEVICE

The sham taVNS group received the same parameters with a current intensity of 0.06 mA.

Interventions

transcutaneous auricular vagus nerve stimulation device

Place the stimulation device on the left auricle and set the stimulation parameters according to the following conditions: a. Waveform: biphase, square wave; b. Wave width: 200 μs; c. Frequency: Alternating between low frequency (4 Hz for 4 s), high frequency (40 Hz for 8 s), and a 4 s pause; d. Intensity: The maximum intensity that induces the strongest sensation the individual can tolerate without causing pain, usually 1.5-3.5 mA; e. Treatment duration: Each treatment lasted 30 minutes, twice daily (8:00, 16:00) for 10 days.

Intervention Type: DEVICE

Sham device

The sham taVNS group received the same parameters with a current intensity of 0.06 mA.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kaijiang Kang

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Kaijiang Kang, MD

Role: primary

kangkaijiang678@126.com

+8618210554710

Chuanying Wang, MD

Role: backup

chuanying616@163.com

+8618515356680

Other Identifiers

KangKJ

Identifier Type: -

Identifier Source: org_study_id