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NOT YET RECRUITING
NCT07454070
NA

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

Sponsor: Jing Han

View on ClinicalTrials.gov

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 .

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-03-08

Completion Date

2026-09-28

Last Updated

2026-03-06

Healthy Volunteers

No

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.

Locations (1)

Tang-Du Hospital,Department of Cardiology

Xi’an, Shanxi, China