Clinical trial NCT06918964: TaVNS for Acute Intracerebral Hemorrhage
Official title: Efficacy and Safety of Transcutaneous Auricular Vagus Nerve Stimulation for Acute Intracerebral Hemorrhage
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral Hemorrhage
taVNS
perihemtomal edema
neuroinflammation
secondary brain injury
Lead sponsor: Beijing Tiantan Hospital
Sponsor class: OTHER
First posted: 2025-04-09
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Primary outcomes:
measure: Volume of perihematoma edema assessed by CT
timeFrame: Day 10-14 after randomization
Secondary outcomes:
measure: Autonomic activity assessed by heart rate variability
timeFrame: Day 10-14 after randomization
measure: Autonomic activity assessed by baroreflex sensitivity
timeFrame: Day 10-14 after randomization
measure: National Institutes of Health stroke scale (NIHSS)
timeFrame: Day 10-14 after randomization
measure: GCS (Glasgow Coma Scale)
timeFrame: Day 10-14 after randomization
measure: MMSE (Mini-Mental State Examination)
timeFrame: Day 10-14 after randomization
measure: MoCA (Montreal Cognitive Assessment)
timeFrame: Day 10-14 after randomization
measure: PHQ-9 (Patient Health Questionnaire-9)
timeFrame: Day 10-14 after randomization
measure: 90-day National Institutes of Health stroke scale (NIHSS)
timeFrame: 90 ± 7 days after randomization
measure: 90-day modified Rankin Scale (mRS)
timeFrame: 90 ± 7 days after randomization
measure: 90-day EQ-5D (EuroQol 5-Dimension Questionnaire) score
timeFrame: 90 ± 7 days after randomization
measure: 90-day GCS (Glasgow Coma Scale)
timeFrame: 90 ± 7 days after randomization
measure: 90-day MMSE (Mini-Mental State Examination)
timeFrame: 90 ± 7 days after randomization
measure: 90-day MoCA (Montreal Cognitive Assessment)
timeFrame: 90 ± 7 days after randomization
measure: 90-day PHQ-9 (Patient Health Questionnaire-9)
timeFrame: 90 ± 7 days after randomization
Other outcomes:
measure: Safety assessment
timeFrame: In the 10-day treatment period
measure: Perihematomal blood-brain barrier permeability
timeFrame: Day 5-7 after randomization
measure: Evaluation of glymphatic system
timeFrame: Day 5-7 after randomization
measure: Assessment of microglial activation
timeFrame: Day 7-9 after randomization
measure: Interleukin-1β (IL-1β) level in peripheral blood
timeFrame: Day 10-14 after randomization
measure: Interleukin-6 (IL-6)
timeFrame: Day 10-14 after randomization
measure: Tumor Necrosis Factor-alpha (TNF-α)
timeFrame: Day 10-14 after randomization
measure: Interleukin-4 (IL-4)
timeFrame: Day 10-14 after randomization
measure: Interleukin-10 (IL-10)
timeFrame: Day 10-14 after randomization
measure: Transforming Growth Factor-beta (TGF-β)
timeFrame: Day 10-14 after randomization
measure: Neurofilament light chain (NFL)
timeFrame: Day 10-14 after randomization
measure: Monocyte subsets
timeFrame: Day 10-14 after randomization
measure: CD4+ T cells
timeFrame: Day 10-14 after randomization
measure: CD8+ T cells
timeFrame: Day 10-14 after randomization
measure: NK cells
timeFrame: Day 10-14 after randomization
measure: B cells
timeFrame: Day 10-14 after randomization
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
Study officials:
References: