Actively Recruiting
Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety
Led by Shenyang Medical College · Updated on 2026-04-22
56
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
S
Shenyang Medical College
Lead Sponsor
T
The Second Hospital of Shenyang Medical College
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years, any sex.
- Right-handed, with resting heart rate between 60 and 100 beats per minute.
- Confirmed diagnosis of coronary heart disease by positive stress test, documented myocardial infarction, or angiographic coronary artery stenosis ≥50%.
- Diagnosis of an anxiety disorder based on DSM-5.
- Hamilton Anxiety Rating Scale score ≥16 and Hamilton Depression Rating Scale score ≥17.
You will not qualify if you...
- Acute unstable angina.
- Severe congestive heart failure (New York Heart Association class IV).
- Valvular heart disease.
- History of atrial fibrillation.
- Unstable blood pressure (systolic >180 mmHg or <90 mmHg).
- Pregnancy.
- History of unstable medical conditions such as cerebrovascular disease, dementia, hyperthyroidism, pulmonary disease, or malignancy.
- 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 enrollment.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
L
Lin Tao, MM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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