Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety

Summary

The goal of this clinical trial is to test whether real-time fNIRS-BCI neurofeedback targeting the right dorsolateral prefrontal cortex (right DLPFC), using active volitional control during a slow-wave auditory acoustic paradigm, can suppress cardiac sympathetic activity and improve autonomic regulation in right-handed patients with stable coronary heart disease (CHD) and comorbid DSM-5 anxiety.

The main questions it aims to answer are:

Does real neurofeedback, compared with sham, reduce baseline-corrected heart rate during the auditory stimulation window? Does real neurofeedback, compared with sham, increase HRV spectral power around 0.0167 Hz (1/60 Hz) and produce stronger suppression of right DLPFC activation? Does suppression of right DLPFC activation mediate the effect of group assignment on heart rate?

If there is a comparison group: Researchers will compare the real neurofeedback group with the sham (non-contingent) feedback group, which uses identical audio and interface, to determine whether coupling feedback to right DLPFC activity yields autonomic benefits.

Participants will:

Complete eligibility screening in cardiology and psychiatry and provide informed consent; baseline demographics, medical history, vital signs, and medications are recorded (HAMA/HAMD used for eligibility only).

Undergo a 3-day adaptation phase to practice active volitional self-regulation while viewing a real-time energy bar mapped to right DLPFC statistics; adaptation data are not analyzed for outcomes.

Attend two formal sessions (Days 4-5), each with 15 blocks of 60 s (20 s rest + 40 s stimulus). The auditory stimulus is a 1 Hz amplitude-modulated pure tone at approximately 60 dB; 10-second white-noise bursts are randomly embedded within the 40-second window. During the stimulation period, participants receive real or sham feedback on right DLPFC activation and act to push the energy bar below an unlabeled threshold line using active volitional strategies.

Undergo synchronous fNIRS (HbO) and 3-lead ECG (1,000 Hz) recording throughout; online processing and rendering performance metrics are logged; adverse events are monitored and managed per protocol.

Conditions

• Coronary Heart Disease (CHD)
• Anxiety Disorders

Interventions

DEVICE

Real-time fNIRS-ECG neurofeedback

This intervention uses real-time neurofeedback based on right dorsolateral prefrontal cortex (right DLPFC) activity measured by functional near-infrared spectroscopy (fNIRS), with simultaneous ECG recording. During a slow-wave auditory paradigm (1 Hz amplitude-modulated tone with embedded white noise), participants attempt to downregulate right DLPFC activation via active volitional strategies, guided by a visual energy bar. Before formal intervention, a 3-day adaptation phase familiarises participants with the interface and task, under guidance. The formal training occurs on Days 4-5 (15 blocks/day), using identical auditory input and recording protocol. Participants are randomised to real or sham feedback groups, differing only in the statistical threshold used to generate feedback (T = -3.3 vs T = -1.0). Participants and assessors are blinded to allocation.

Sponsors & Collaborators

• The Second Hospital of Shenyang Medical College

  collaborator OTHER

• Shenyang Medical College

  lead OTHER

Principal Investigators

• Yun-En Liu, MD · Shenyang Medical College

• Lin Tao, MM · 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

2025-11-19

Primary Completion

2026-08-20

Completion

2026-08-21

Countries

• China

Study Locations