Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06918964

TaVNS for Acute Intracerebral Hemorrhage

Led by Beijing Tiantan Hospital · Updated on 2026-01-15

186

Participants Needed

1

Research Sites

167 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

TaVNS for Acute Intracerebral Hemorrhage

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related)
  • Primary intraventricular hemorrhage
  • Parenchymal hemorrhage rupturing into the ventricles with extensive ventricular blood filling
  • Progressive neurological or other severe diseases
  • Planned surgical treatment within 24 hours
  • Pre-existing disability caused by previous illnesses with Modified Rankin Scale score ≥ 3
  • 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 expected survival less than 3 months
  • Hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other disorders affecting autonomic nervous function
  • Use of medications interfering with autonomic function 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China, 100070

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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TaVNS for Acute Intracerebral Hemorrhage | DecenTrialz