Study of Non-Invasive Ear Vagus Nerve Stimulation to Reduce Depression in Adults With Acute Coronary Syndrome After Heart Procedure PCI

What this Trial Is About

Researchers are evaluating the effects of transcutaneous auricular Vagus Nerve Stimulation taVNS on patients aged 18 to 80 years who have had Acute Coronary Syndrome ACS and undergone Percutaneous Coronary Intervention PCI within the past year. This study focuses on those with mild-to-moderate depression, as measured by the Hamilton Depression Rating Scale HAMD, and aims to assess whether taVNS can reduce depressive symptoms compared to a sham treatment. The trial also explores anxiety, post-traumatic stress disorder, quality of life, and cardiac function in this population. Participants are randomly assigned to receive either active taVNS or sham taVNS devices. Both groups self-administer stimulation twice daily for 20 minutes over eight weeks at home after training. The active device delivers electrical stimulation to the left ears cymba conchae, while the sham device only stimulates briefly without ongoing current. Following the treatment, an eight-week follow-up period monitors continued effects. Weekly visits occur during treatment to evaluate symptoms and safety. Throughout the 16-week study, participants complete various psychological assessments including HAMD, Hamilton Anxiety Rating Scale, Beck Depression Inventory, and Posttraumatic Stress Disorder Checklist. Physiological tests such as heart rate variability, echocardiography, and blood markers are performed at baseline, during treatment, and follow-up. Researchers track major cardiovascular events and adverse effects. Participants keep diaries to record treatment adherence and any issues, with regular review by the study team.

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