Closed-loop neurofeedback targeting the right prefrontal cortex to improve heart regulation in people with coronary heart disease and 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

This trial will try real-time fNIRS neurofeedback aimed at the right dorsolateral prefrontal cortex to lower sympathetic heart activity and improve heart rate variability in right-handed adults with stable coronary heart disease and DSM-5 anxiety.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 56 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Shenyang Medical College (other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT07238920 on ClinicalTrials.gov

What this trial studies

This randomized, sham-controlled, parallel-group trial uses real-time fNIRS-BCI neurofeedback to modulate right DLPFC activity in right-handed adults with stable coronary heart disease and comorbid DSM-5 anxiety. Participants complete screening, a three-day adaptation phase, and then two consecutive formal experimental sessions consisting of 15 blocks of 60 seconds each (20 seconds rest, 40 seconds auditory stimulation) while wearing fNIRS and ECG sensors. Real feedback maps statistical measures of cortical activation to a visual energy bar for active volitional suppression, while the sham arm receives non-contingent feedback; the auditory paradigm uses a 1 Hz amplitude-modulated tone with randomized 10-second white-noise probes. Primary outcomes include baseline-corrected heart rate during stimulation and HRV spectral power near 0.0167 Hz, and analyses will test whether suppression of right DLPFC mediates heart rate effects.

Who should consider this trial

Good fit: Ideal candidates are right-handed adults over 18 with confirmed stable coronary heart disease, a DSM-5 anxiety disorder, HAMA score ≥16, HAMD-17 score ≤17, resting heart rate 60–100 bpm, and no acute or unstable cardiac conditions.

Not a fit: Patients with acute unstable angina, NYHA class IV heart failure, atrial fibrillation, significant valvular disease, unstable blood pressure, left-handedness, or who do not meet the anxiety or cardiac inclusion criteria are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could reduce sympathetic heart activity and improve autonomic balance, potentially lowering cardiac stress and easing anxiety-related autonomic symptoms.

How similar studies have performed: While HRV biofeedback and some neurofeedback approaches have demonstrated improvements in autonomic regulation and anxiety, closed-loop fNIRS-BCI specifically targeting right DLPFC for cardiac autonomic modulation is largely novel with limited prior evidence.

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Where this trial is running

Shenyang, Liaoning

• The Second Affiliated Hospital of Shenyang Medical College — Shenyang, Liaoning, China (RECRUITING)

Study contacts

• Principal investigator: Lin Tao, MM — Shenyang Medical College
• Study coordinator: Yun-En Liu, MD

Conditions: Coronary Heart Disease, Anxiety Disorders, Coronary heart disease, Anxiety, Neurofeedback, Heart rate variability