Transcutaneous auricular vagus nerve stimulation for depression after heart procedures

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, double-blind, sham-controlled trial, adults with ACS who recently underwent PCI and have mild-to-moderate depression (HAMD 7–23, with higher HAMD than HAMA) will use taVNS or sham taVNS at home for 20 minutes, twice daily, for 8 weeks, with an additional 8-week follow-up. Primary outcomes focus on depression scores (HAMD), while secondary outcomes include anxiety (HAMA), PTSD symptoms (PCL-C), and cardiac function markers. Participants are 14 days to 12 months post-PCI, hemodynamically stable, and must meet DSM-5 criteria for depression without prior psychiatric treatment commitments; exclusion criteria include severe heart failure and uncontrolled hypertension. Lead sponsor is Jing Han, with the study conducted at Tang-Du Hospital in Xi'an, China.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 years
* Meeting the diagnostic criteria for ACS
* 14 days to 12 months after successful PCI, with stable vital signs
* Meeting the diagnostic criteria for depression according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)
* HAMD-17 score ≥7 and \<24 (mild-to-moderate depression), with HAMA score \<HAMD score;
* Refusal of psychiatric consultation, antidepressant medication, or psychological therapy by the patient or their legal representative after full informed consent
* Voluntary participation in the study and signing of the informed consent form

Exclusion Criteria:

* Severe heart failure (New York Heart Association \[NYHA\] class ≥III)
* Uncontrolled hypertension (systolic blood pressure ≥180 mmHg and diastolic blood pressure ≥110 mmHg)
* Electrocardiographic abnormalities (first-degree atrioventricular block with PR interval ≥0.20 s, second-degree type II or third-degree atrioventricular block at any time, 24-hour average heart rate ≤50 beats per minute, RR interval ≥3 s) or a history of syncope unrelated to the current ACS
* Dialysis-dependent patients
* Previous renal sympathetic denervation or vagal ganglion ablation
* Expected survival time \<4 months
* Pre-PCI diagnosis of severe mental illnesses, including schizophrenia, severe intellectual disability, or substance abuse
* Current use of antipsychotic medications
* High suicide risk
* Pregnant or lactating women
* Left ear diseases, acute exacerbation of asthma or chronic obstructive pulmonary disease, or other conditions precluding taVNS treatment
* Implanted cardiac pacemaker, implantable cardioverter-defibrillator (ICD), or other implantable stimulators (e.g., vagus nerve stimulator, deep brain stimulator)

Where it's running

• Tang-Du Hospital,Department of Cardiology
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Principal investigator: wangang Guo, Doctor of Philosophy — Department of Cardiology,Tang-Du Hospital
• Study coordinator: jing Han, Pursuing Master's Degree
• Email: 710694996@qq.com
• Phone: 8618506576253

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.