Actively Recruiting
Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety - A Randomized, Sham-Controlled Trial
Led by Shenyang Medical College · Updated on 2026-04-22
56
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating whether real-time functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback targeting the right dorsolateral prefrontal cortex (right DLPFC) can reduce cardiac sympathetic activity and improve autonomic regulation. This study focuses on right-handed adults with stable coronary heart disease (CHD) and comorbid anxiety diagnosed by DSM-5. The goal is to determine if this neurofeedback, compared with sham feedback, can lower heart rate during auditory stimulation and increase heart rate variability (HRV). Participants practice controlling right DLPFC activation over a 3-day adaptation phase using a visual energy bar reflecting brain activity. The formal study sessions occur on two consecutive days, each with 15 cycles of rest and auditory stimulation involving a 1 Hz tone with embedded white noise. Participants receive either real neurofeedback with a sensitive threshold linking brain activity to the feedback bar or sham feedback with a weaker link. Brain signals are recorded with fNIRS and heart activity with ECG throughout sessions. Participants complete screening and consent before the adaptation phase. During the formal sessions, researchers collect continuous brain and heart data, perform online processing, and monitor safety. The main measurement compares heart rate changes between real and sham groups during stimulation. Secondary measures assess right DLPFC activation and HRV spectral power. Safety monitoring includes tracking adverse events like dizziness or headache. Data will be securely handled and shared after publication.
CONDITIONS
Brief Title
Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 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 heart attack with ECG changes and enzyme elevation, or angiographically confirmed artery narrowing of 50% or more
- Diagnosis of an anxiety disorder according to DSM-5
- Hamilton Anxiety Rating Scale score 16 or higher and Hamilton Depression Rating Scale score 17 or lower
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
- 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 to avoid interference with measurements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 days
Participants complete a three-day adaptation phase to familiarize themselves with the neurofeedback interface and task under guidance.
3 visits (in-person, one per day)
Duration - 2 days
Participants undergo two formal experimental neurofeedback sessions on consecutive days, each consisting of 15 block cycles of auditory stimulation and real-time fNIRS-ECG feedback targeting the right dorsolateral prefrontal cortex. Participants use active volitional strategies to modulate neural activity based on visual feedback.
2 visits (in-person, one per day)
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital of Shenyang Medical College
Shenyang, Liaoning, China, 110001
Actively Recruiting
Research Team
Y
Yun-En Liu, MD
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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