Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety
Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety - A Randomized, Sham-Controlled Trial
Shenyang Medical College
56 participants
Nov 19, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Age >18 years, any sex.
- Right-handed, with resting heart rate between 60 and 100 beats per minute.
- Confirmed diagnosis of CHD, defined as at least one of the following:
- (i) positive stress test; (ii) documented myocardial infarction (MI) with electrocardiographic changes and concurrent elevation of creatine kinase MB isoenzyme or troponin; (iii) angiographically confirmed coronary atherosclerosis with ≥50% stenosis in at least one coronary artery.
- Diagnosis of an anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).
- Hamilton Anxiety Rating Scale (HAMA) score ≥16 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≤17.
Exclusion Criteria10
- Acute unstable angina.
- Severe congestive heart failure (New York Heart Association \[NYHA\] class IV).
- Valvular heart disease.
- History of atrial fibrillation.
- Unstable blood pressure, defined as systolic blood pressure >180 mmHg or <90 mmHg.
- Pregnancy.
- History of unstable medical conditions, including cerebrovascular disease, dementia, hyperthyroidism, pulmonary disease, or malignancy. These are assessed through medical history, electronic health records, physical examination, and ECG findings.
- High risk of suicide or homicide.
- Presence of other psychiatric disorders, including psychotic disorders, bipolar disorder, or active substance use disorders.
- Use of psychotropic medication within 1 month prior to enrolment, to avoid potential interference with haemodynamic measurements.
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Interventions
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.
Locations(1)
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NCT07238920