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New treatment option for Coronary Heart Disease (CHD)
Official title Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety
ClinicalTrials.gov ID: NCT07244484
What this study is testing
- What it's testing
- 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?
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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 ≥16 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≤17.
You likely can't join if
- 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.
See the full eligibility 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...
- 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 ≥16 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≤17.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shenyang, Liaoning, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shenyang, Liaoning, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.