TaVNS for Acute Intracerebral Hemorrhage

NCT06918964 | Recruiting DMC

• 1 other identifier: KangKJ
• Study Type: interventional
• Target: 186
• Locations: 1 country
• Sites: 1

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

Keywords

Intracerebral Hemorrhage; taVNS; perihemtomal edema; neuroinflammation; secondary brain injury

Outcome Measures

Primary Outcomes (1)

• Volume of perihematoma edema assessed by CT

  Relative edema volume.

  Day 10-14 after randomization

Secondary Outcomes (14)

• Autonomic activity assessed by heart rate variability

  Day 10-14 after randomization

• Autonomic activity assessed by baroreflex sensitivity

  Day 10-14 after randomization

• National Institutes of Health stroke scale (NIHSS)

  Day 10-14 after randomization

• GCS (Glasgow Coma Scale)

  Day 10-14 after randomization

• MMSE (Mini-Mental State Examination)

  Day 10-14 after randomization

Other Outcomes (16)

• Safety assessment

  In the 10-day treatment period

• Perihematomal blood-brain barrier permeability

  Day 5-7 after randomization

• Evaluation of glymphatic system

  Day 5-7 after randomization

Study Arms (2)

taVNS intervention

ACTIVE COMPARATOR

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

Device: transcutaneous auricular vagus nerve stimulation device

Sham taVNS intervention

SHAM COMPARATOR

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

Device: Sham device

Interventions

transcutaneous auricular vagus nerve stimulation device 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.

taVNS intervention

Sham device DEVICE

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

Sham taVNS intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Secondary intracerebral hemorrhage (e.g., traumatic, tumor-related, vascular malformation, aneurysm, or coagulopathy-related).
• Primary intraventricular hemorrhage.
• 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.
• Planned surgical treatment within 24 hours.
• Pre-existing disability caused by previous illnesses: Modified Rankin Scale (mRS) score ≥ 3.
• 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.
• Patients with hyperthyroidism, hypothyroidism, syncope, epilepsy, multiple sclerosis, Parkinson's disease, multiple system atrophy, or other known disorders affecting autonomic nervous function.
• Use of medications that interfere with autonomic function (e.g., beta-blockers, theophylline, tricyclic antidepressants, or steroids) 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.

Sponsors & Collaborators

• Beijing Tiantan Hospital: lead

Study Sites (1)

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, 100070, China

RECRUITING

MeSH Terms

Conditions

Cerebral Hemorrhage; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The participants and outcome assessors are unaware of the trial grouping.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: April 9, 2025
• Study Start: September 15, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)