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Efficacy and safety study of noninvasive transcutaneous auricular vagal nerve stimulation for the treatment of heart syndrome after acute ischemic stroke: a multicenter, randomized, controlled clinical trial

Efficacy and safety study of noninvasive transcutaneous auricular vagal nerve stimulation for the treatment of heart syndrome after acute ischemic stroke: a multicenter, randomized, controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500102219
Enrollment
Unknown
Registered
2025-05-12
Start date
2025-06-01
Completion date
Unknown
Last updated
2025-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute ischemic stroke

Interventions

Experimental group:Using non-invasive percutaneous auricular vagus nerve stimulator, stimulate the patients ear vagus nerve branch mainly distribution area, anatomical localization mainly for the auri
auricular electrodes are fixed in the distribution area of the vagus nerve in the ear cavity, and the power is turned on
the frequency is set at 25Hz 500ms with an interval of 30 s. Treatment time and duration: 1 treatment in the morning and 1 treatment in the evening every day, each time for 30 minutes, 7 consecutive d
Control group:The operation was the same as in the experimental group, but no stimulation was performed. No other brain stimulation treatments were performed, and the rest of the treatment measures fo

Sponsors

The First Affiliated Hospital of Chengdu Medical College
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male or female aged >18 years with onset within 24 hours; 2. Diagnosed with acute ischemic stroke according to the diagnostic criteria in the Chinese Guidelines for Diagnosis and Treatment of Acute Ischemic Stroke 2023, with 10 points <= NIHSS score <= 25 points; 3. cTn level within 24 hours is higher than the 99th percentile of the specificity reference line; 4. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Modified Rankin Scale (mRS) =1 before the onset of symptoms. 2. Patients with a clear history of previous cardiac disease, including coronary atherosclerotic heart disease, second- or third-degree atrioventricular block, and left ventricular systolic dysfunction. 3. Patients with severe neurological diseases, including epilepsy, encephalitis, and moderate-to-severe dementia. 4. Patients with severe cardiac, hepatic, or renal dysfunction, or patients in the terminal stage of disease, or patients with malignant tumors or severe hematologic diseases, or patients with immune system diseases, or patients with unstable vital signs. 5. Undergoing surgical debridement intervention. 6. Currently participating in any other interventional clinical trial. 7. Contraindications to transcutaneous auricular vagal nerve stimulation, e.g., cochlear implants, deep brain stimulation therapy. 8. Pregnant or planning a pregnancy.

Design outcomes

Primary

MeasureTime frame
Dynamics of cardio-enzymology;

Countries

China

Contacts

Public ContactLan Wen

The First Affiliated Hospital of Chengdu Medical College

l_wen1225@163.com+86 189 0820 7080

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026