Clinical Trial

Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome

Study acronym: HEART-SET-3
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
This study is a prospective, randomized, sham-controlled, participant- and assessor-blinded, parallel-group clinical trial designed to evaluate the clinical efficacy, mechanistic effects, and safety of right dorsolateral prefrontal cortex (DLPFC) closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback in patients with high-ischaemic-risk chronic coronary syndrome (CCS) and comorbid anxiety disorder. Participants will be randomly assigned in a 1:1 ratio to active neurofeedback or sham feedback. The intervention consists of 4 weeks of treatment, with 20 sessions in total (1 session per weekday, approximately 20 minutes per session). The primary endpoint is the between-group difference in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after treatment. Secondary endpoints include HAMA score and HAMA response rate at the end of treatment, as well as neurophysiological measures collected during Session 1, including right DLPFC activation, heart rate (HR), and heart rate variability (HRV). Exploratory long-term follow-up will assess cardiovascular and bleeding outcomes through 4 years after randomization.
Trial Details
NCT Number NCT07543185
Lead Sponsor Shenyang Medical College
Conditions Chronic Coronary Syndrome, Anxiety Disorder, High Ischemic Risk
Enrollment 214 participants
Start Date 2026-04-19
Primary Completion 2027-06-20 (estimated)
Study Completion 2031-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-04-21