MedTrace Logo

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 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-03-06

No results posted yet for this study

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)

Interventions

DEVICE

Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention

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.

DEVICE

sham Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Control

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.

Sponsors & Collaborators

  • Jing Han

    lead OTHER

Principal Investigators

  • wangang Guo, Doctor of Philosophy · Department of Cardiology,Tang-Du Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-08
Primary Completion
2026-09-10
Completion
2026-09-28

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07454070 on ClinicalTrials.gov