Efficacy of Transcutaneous Auricular Vagus Nerve Stimulation on Alleviating Major Depressive Disorder in Patients With Acute Coronary Syndrome After Percutaneous Coronary Intervention:A Prospective, Double-Blind,Randomized Controlled Study

NCT07454070 | Not Yet Recruiting

• 1 other identifier: TangduH
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, controlled study. ACS follow- up patients aged 18 to 80 years old with hemodynamic stability, who are 14 days to 1 year after PCI, are screened through the HAMD score and the HAMA score. Patients with a HAMD score greater than 7 points and a HAMD score higher than that of the HAMA, are included in this study. Patients were allocated to the active taVNS group or sham taVNS group with a 1:1 ratio. Both groups received the stimulation for 20 minutes each time, twice a day with an 8-week treatment and a 8-week follow-up. All treatments were self-administered by the patients at home after they received training from the hospitals. The primary observation endpoints include the depression scores of the HAMD. The secondary observation endpoints include the HAMA 、GAD、 response and remission rates of HAMD ，as well as the PCL-C for post-traumatic stress disorder. We also observed the cardiac function indexes measured by echocardiography and the B-type natriuretic peptide .

Conditions

Depressive Disorder (Per DSM-V Criteria, Mild-to-moderate); Acute Coronary Syndrome (ACS); Percutaneous Coronary Intervention (PCI); Depressive Disorder; Postoperative Psychological Distress; Heart Rate Variability (HRV); Inflammatory Factors; Randomized Controlled Trial (RCT)

Keywords

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS); Acute Coronary Syndrome (ACS); Post-Percutaneous Coronary Intervention (PCI) Psychological Distress

Outcome Measures

Primary Outcomes (1)

• Change in depressive symptom severity as measured by the 17-item Hamilton Depression Rating Scale (HAMD-17) from baseline (Week 0) to Week 8

  The primary outcome is the change in total HAMD-17 scores from baseline (Week 0, prior to the initiation of transcutaneous auricular vagus nerve stimulation \[taVNS\] intervention) to the end of the 8-week taVNS intervention (Week 8). HAMD-17 scores range from 0 to 52, with higher scores indicating more severe depressive symptoms; a negative change score reflects a reduction in depressive symptom severity and clinical improvement. All assessments are conducted by trained clinicians who are masked to the participants' study group allocation (active taVNS vs. sham taVNS).

  from baseline (Week 0) to Week 8

Secondary Outcomes (15)

• Change in 17-item Hamilton Depression Rating Scale (HAMD-17) scores at multiple time points from baseline (Week 0) to Week 16

  From baseline to week 16 (every 4 weeks)

• Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline (Week 0) to Week 16

  From baseline to week 16 (every 4 weeks)

• Change in Generalized Anxiety Disorder 7-item (GAD-7) scale scores from baseline (Week 0) to Week 16

  From baseline to week 16 (every 4 weeks)

• Change in Beck Depression Inventory (BDI) scores from baseline (Week 0) to Week 16

  From baseline to week 16 (every 4 weeks)

• Change in Posttraumatic Stress Disorder Checklist (PCL) scores from baseline (Week 0) to Week 16

  From baseline to week 16 (every 4 weeks)

Study Arms (2)

Transcutaneous Auricular Vagus Nerve Stimulation Intervention (taVNS)

EXPERIMENTAL

Participants in this arm receive the active transcutaneous auricular vagus nerve stimulation (taVNS) intervention as defined in the corresponding Intervention section. The intervention is administered twice daily for 20 minutes per session, continuously for 8 weeks, with weekly follow-up visits to assess depressive symptoms and stimulation safety.

Device: Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention

Sham Transcutaneous Auricular Vagus Nerve Stimulation Control(sham taVNS)

SHAM COMPARATOR

Participants in this arm receive the sham transcutaneous auricular vagus nerve stimulation (sham taVNS) intervention as defined in the corresponding Intervention section. The sham intervention is delivered twice daily for 20 minutes per session over 8 weeks, matching the active group in procedure duration and frequency to maintain participant blinding, with weekly follow-up assessments identical to the active arm.

Device: sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control

Interventions

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention DEVICE

Transcutaneous auricular vagus nerve stimulation (taVNS) is delivered to the cymba conchae of the ear using a dedicated stimulator device, with parameters set as 20 Hz frequency, 0.5-3mA intensity, 20 minutes per session, twice daily for 8 weeks.

Also known as: aVNS

Transcutaneous Auricular Vagus Nerve Stimulation Intervention (taVNS)

sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control DEVICE

sham Transcutaneous Auricular Vagus Nerve Stimulation Control treatment with the same device of active stimulation group, wearing method, and parameter adjustments as active stimulation group However, stimulation will only be delivered for the first 5 seconds, with no subsequent electrical output. Treatment frequency will be identical to that of active stimulation group.

Sham Transcutaneous Auricular Vagus Nerve Stimulation Control(sham taVNS)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Male and female participants are permitted to enroll. Gender stratification will be implemented at the time of participant recruitment and randomization to facilitate subgroup analysis of trial outcomes by gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years
• Meeting the diagnostic criteria for ACS
• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Jing Han: lead

Study Sites (1)

Tang-Du Hospital,Department of Cardiology

Xi’an, Shanxi, 710038, China

Location

Related Links

• This study demonstrates the efficacy of transcutaneous auricular vagus nerve stimulation (taVNS) for mild-to-moderate major depressive disorder (MDD), providing critical evidence to support the rationale of the current trial.

MeSH Terms

Conditions

Depressive Disorder; Acute Coronary Syndrome

Interventions

Methods

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• wangang Guo, Doctor of Philosophy

  Department of Cardiology,Tang-Du Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

jing Han, Pursuing Master's Degree

CONTACT

8618506576253; 710694996@qq.com

wangang Guo, Doctor of Philosophy

CONTACT

8618629581753; Guowagon@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, Department of Cardiology, Tang-Du Hospital

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: March 6, 2026
• Study Start: March 8, 2026
• Primary Completion (Estimated): September 10, 2026
• Study Completion (Estimated): September 28, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)