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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: lye9901@163.com
• Phone: 86-24-62215130

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.