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Efficacy and Safety of Non-Invasive Transcutaneous Auricular Vagus Nerve Stimulation for the Prevention of Stroke-Associated Pneumonia in Patients with Ischemic Stroke: A Prospective, Multicenter, Randomized Controlled Trial

Efficacy and Safety of Non-Invasive Transcutaneous Auricular Vagus Nerve Stimulation for the Prevention of Stroke-Associated Pneumonia in Patients with Ischemic Stroke: A Prospective, Multicenter, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110588
Enrollment
Unknown
Registered
2025-10-16
Start date
2025-10-17
Completion date
Unknown
Last updated
2025-10-20

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

Conditions

Ishemic stroke

Interventions

Intervention Group:Use a non-invasive transcutaneous auricular vagus nerve stimulator to stimulate the main distribution areas of the auricular vagal branches, anatomically localized to the concha and
earlobe electrodes are securely fixed bilaterally over the vagal nerve distribution areas in the concha, and the device is powered on. Set the stimulation waveform to a dense-sparse pattern at 4/20 Hz
all other treatments follow specialty guidelines.
Control Group:The procedure is identical to that of the intervention group, except that no stimulation is delivered. No additional brain stimulation therapies will be administered, and all other treat

Sponsors

Xindu District People’s Hospital of Chengdu
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Age 18–80 years, with symptom onset within 24 hours; 2. Diagnosis of acute ischemic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke (2023), with an NIHSS score >=8; 3. Informed consent signed by the patient and/or legal representative.

Exclusion criteria

Exclusion criteria: 1. Newly developed pulmonary infection or recent craniocerebral trauma; 2. Presence of severe neurological disorders, including epilepsy, encephalitis, or moderate-to-severe dementia; 3. Severe cardiac, hepatic, or renal dysfunction; patients in the terminal stage of disease; patients with malignancies or severe hematological disorders; or those with acute myocardial infarction; 4. Special populations, such as pregnant patients; 5. Patients with poor compliance.

Design outcomes

Primary

MeasureTime frame
Incidence of SAP ;

Secondary

MeasureTime frame
Pneumonia Severity Index;Heart rate variability (HRV; Blood pressure variability (BPV) ; Skin adverse reactions ;Inflammatory markers (Serum IL-6, TNF-a, C-reactive protein, procalcitonin, and routine blood tests);Proteomic analysis of blood samples and single-cell sequencing of bronchoalveolar lavage fluid (if necessary);

Countries

China

Contacts

Public ContactZhang Jun

Xindu District People’s Hospital of Chengdu

501838695@qq.com+86 180 8092 5075

Outcome results

None listed

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