Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07244484

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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.
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China, 110001

Actively Recruiting

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here