NCT06918964 TaVNS for Acute Intracerebral Hemorrhage
| NCT ID | NCT06918964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tiantan Hospital |
| Condition | Intracerebral Hemorrhage |
| Study Type | INTERVENTIONAL |
| Enrollment | 186 participants |
| Start Date | 2025-09-15 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 186 participants in total. It began in 2025-09-15 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT06918964 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Intracerebral Hemorrhage. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06918964 currently recruiting?
Yes, NCT06918964 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Tiantan Hospital to inquire about joining.
Where is the NCT06918964 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT06918964 clinical trial?
NCT06918964 is sponsored by Beijing Tiantan Hospital. The trial plans to enroll 186 participants.