Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety - A Randomized, Sham-Controlled Trial

What this Trial Is About

This research aims to evaluate whether closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback targeting the left dorsolateral prefrontal cortex (DLPFC) can reduce cardiac autonomic arousal during cold-induced pain stress in adults with stable coronary heart disease (CHD) and anxiety disorders. The trial also compares real neurofeedback with sham neurofeedback to study effects on heart rate and brain activation patterns, exploring the link between anxiety and heart function. It is a randomized, sham-controlled, exploratory clinical trial involving adults with confirmed CHD and DSM-5 anxiety disorders. Participants are randomly assigned to either a real neurofeedback group or a sham neurofeedback group. Both groups receive three days of adaptive training sessions involving self-regulation strategies to activate the left DLPFC with visual feedback, slow-wave auditory stimulation, and mild cold-water exposure while electrocardiography (ECG) is recorded. On day 4, participants complete a formal experimental session with 15 blocks of cold-pain stimulation and auditory cues, during which fNIRS and ECG data are recorded simultaneously. The real neurofeedback group receives feedback tightly linked to true brain activation, while the sham group receives feedback minimally coupled to actual brain signals. Participants undergo cardiac and psychiatric screening before enrollment and are monitored for adverse events throughout the trial. Assessments include heart rate changes during the cold-pain task and brain imaging data measuring left DLPFC activation and inter-hemispheric synchronisation. Safety evaluations focus on events related to cardiac function, cold-pain tolerance, and sensor irritation. The study duration includes four days of training and testing, with detailed physiological recordings and statistical analyses to compare effects between groups.

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