TaVNS for Acute Intracerebral Hemorrhage (NCT06918964) | Clinical Trial Compass
RecruitingNot Applicable
TaVNS for Acute Intracerebral Hemorrhage
China186 participantsStarted 2025-09-15
Plain-language 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.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. 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.
✕. 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.
✕. 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.