Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07238920

Closed-Loop Neurofeedback Targeting the Right 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

39 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 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 neurofeedback group with the sham (non-contingent) feedback group, which uses identical audio and interface, to determine whether coupling feedback to right DLPFC activity yields autonomic benefits. Participants will: Complete eligibility screening in cardiology and psychiatry and provide informed consent; baseline demographics, medical history, vital signs, and medications are recorded (HAMA/HAMD used for eligibility only). Undergo a 3-day adaptation phase to practice active volitional self-regulation while viewing a real-time energy bar mapped to right DLPFC statistics; adaptation data are not analyzed for outcomes. Attend two formal sessions (Days 4-5), each with 15 blocks of 60 s (20 s rest + 40 s stimulus). The auditory stimulus is a 1 Hz amplitude-modulated pure tone at approximately 60 dB; 10-second white-noise bursts are randomly embedded within the 40-second window. During the stimulation period, participants receive real or sham feedback on right DLPFC activation and act to push the energy bar below an unlabeled threshold line using active volitional strategies. Undergo synchronous fNIRS (HbO) and 3-lead ECG (1,000 Hz) recording throughout; online processing and rendering performance metrics are logged; adverse events are monitored and managed per protocol.

CONDITIONS

Official Title

Closed-Loop Neurofeedback Targeting the Right 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 at least one of: positive stress test, documented myocardial infarction with ECG changes and enzyme elevation, or angiographically confirmed coronary artery stenosis ≥50%
  • Diagnosed anxiety disorder according to DSM-5
  • Hamilton Anxiety Rating Scale (HAMA) score ≥16 and Hamilton Depression Rating Scale (HAMD-17) score ≥17
Not Eligible

You will not qualify if you...

  • Acute unstable angina
  • Severe congestive heart failure (NYHA 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
  • 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

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Trial Site Locations

Total: 1 location

1

The Second Affiliated Hospital of Shenyang Medical College

Shenyang, Liaoning, China, 110001

Actively Recruiting

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Research Team

Y

Yun-En Liu, MD

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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