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Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety
Sponsor: Shenyang Medical College
Summary
The goal of this clinical trial is to test whether closed-loop fNIRS-BCI neurofeedback(NF) targeting the left dorsolateral prefrontal cortex(DLPFC) can reduce cardiac autonomic arousal, indexed by baseline-corrected heart rate(HR) under cold-induced pain stress, in adults with stable coronary heart disease(CHD) and comorbid anxiety. The main questions it aims to answer are: Does real left DLPFC neurofeedback, compared with sham neurofeedback, lead to a greater reduction in baseline-corrected HR during the cold-induced pain stimulation window? Does real neurofeedback produce stronger volitional upregulation of left DLPFC activation and higher inter-hemispheric synchronisation between left and right DLPFC than sham neurofeedback? Are changes in baseline-corrected HR statistically associated with, and partly mediated by, changes in left DLPFC activation or DLPFC inter-hemispheric synchronisation? What adverse events(AEs) occur during adaptive training and the formal experimental session, and do AE rates differ between the two groups? Researchers will compare a real neurofeedback group with a sham neurofeedback group to determine whether targeting the left DLPFC via closed-loop fNIRS-BCI yields superior modulation of cardiac autonomic responses and prefrontal activation patterns in CHD patients with anxiety. Participants will: undergo cardiac and psychiatric screening to confirm stable CHD, DSM-5 anxiety disorder, and other eligibility criteria; attend three adaptive training sessions(days 1-3) with fNIRS-BCI neurofeedback targeting the left DLPFC, combined with slow-wave auditory stimulation and mild cold-water exposure, while ECG is recorded; on day 4, complete one formal experimental session consisting of 15 blocks of cold-induced pain stimulation and slow-wave auditory stimulation, with simultaneous fNIRS and ECG recording, receiving either real or sham left DLPFC neurofeedback according to randomisation, and continuous monitoring for adverse events.
Official title: Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety - A Randomized, Sham-Controlled Trial (HEART-SET-2)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
56
Start Date
2025-11-23
Completion Date
2026-05-30
Last Updated
2025-11-24
Healthy Volunteers
No
Interventions
Real-time fNIRS-based neurofeedback
Real-time fNIRS-based neurofeedback is a non-invasive brain-computer interface procedure that uses functional near-infrared spectroscopy to monitor cortical haemodynamic activity online and return it as visual feedback. In this trial, an optode montage is placed over the bilateral prefrontal cortex, with the left dorsolateral prefrontal cortex (DLPFC) defined as the target region. Oxygenated haemoglobin (HbO) signals from the left DLPFC are preprocessed in real time and entered into a sliding-window general linear model to generate a task-related test statistic. A sign-inverted version of this statistic is mapped to an on-screen "energy bar", such that stronger left DLPFC activation corresponds to a lower bar. Participants are instructed to use self-regulation strategies to push the bar below a preset threshold while exposed to cold-induced pain and 1 Hz slow-wave auditory stimulation, thereby forming a closed loop between prefrontal activation and feedback.
Locations (1)
Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China