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

RecruitingNAAges 18 Years - anyAllShenyang Medical College
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In plain words

What the trial is, and whether it could suit you

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 neurofeedba

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ50% 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 โ‰ฅ16 and 17-item Hamilton Depression Rating Scale (HAMD-17) score โ‰ค17. 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.
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What it tests

  • Real-time fNIRS-ECG neurofeedback
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Where

1 site
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, China
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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