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

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.

Conditions

• Chronic Coronary Syndrome
• Anxiety Disorder
• High Ischemic Risk

Interventions

DEVICE

Active right DLPFC closed-loop fNIRS-BCI neurofeedback

A closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback intervention targeting the right dorsolateral prefrontal cortex (DLPFC). Participants receive 20 sessions over 4 weeks, delivered once daily on weekdays, with each session lasting approximately 20 minutes. The training uses a 60-second cycle consisting of 20 seconds of rest and 40 seconds of auditory cueing, with a 1 Hz sinusoidally amplitude-modulated pure tone as the main cue. During training, the system provides real-time feedback coupled to right DLPFC hemodynamic activity to guide intentional downregulation.

DEVICE

Sham right DLPFC closed-loop fNIRS-BCI neurofeedback

A sham closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback condition delivered with procedures identical to the active intervention, including the same visit schedule, auditory cues, training duration, interface appearance, and follow-up assessments. Participants receive 20 sessions over 4 weeks, delivered once daily on weekdays, with each session lasting approximately 20 minutes. The feedback signal is not meaningfully coupled to real-time right DLPFC activity.

Sponsors & Collaborators

• Shenyang Medical College

  lead OTHER

Principal Investigators

• Lin Tao, Assoc.Prof. · Shenyang Medical College

• Yun-En Liu, MD · Shenyang Medical College

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-19

Primary Completion

2027-06-20

Completion

2031-02-20

Countries

• China

Study Locations