[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611738":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":33,"locations":38,"responsibleParty":59,"collaborators":62,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":25,"enrollmentInfo":75,"targetDuration":25,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":41,"whyStopped":25,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Shenyang Medical College","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Real Neurofeedback Group","EXPERIMENTAL","Participants in this arm receive real closed-loop fNIRS-BCI neurofeedback targeting the left dorsolateral prefrontal cortex(DLPFC). After baseline cardiac and psychiatric assessment, they complete three adaptive training sessions(days1-3) to practice volitional upregulation of left DLPFC activation with visual feedback, slow-wave(1Hz) auditory stimulation, and mild cold-water exposure. On day4, they undergo one formal experimental session comprising 15 blocks(20s rest+40s stimulation) with simultaneous fNIRS and ECG recording. During stimulation, participants receive a 1Hz amplitude-modulated auditory tone and cold-induced pain stress(0-2°C bottle contact). In the real neurofeedback arm, the on-screen \"energy bar\" is tightly and directionally coupled to the real-time fNIRS-derived statistic from left DLPFC(HbO), using a stringent threshold(t≈+3.3), so that greater true activation produces a clear, interpretable change in visual feedback to support effective closed-loop self-regulation",[13],"Device: Real-time fNIRS-based neurofeedback",{"label":15,"type":16,"description":17,"interventionNames":18},"Sham Neurofeedback Group","SHAM_COMPARATOR","Participants in this arm receive sham closed-loop fNIRS-BCI neurofeedback with the same procedures as the real neurofeedback group, but with feedback minimally coupled to true left DLPFC activity. After baseline cardiac and psychiatric assessment, they complete three adaptive training sessions (days 1-3) and one formal experimental session on day 4. Each session uses 15 blocks (20 s rest + 40 s stimulation) with simultaneous fNIRS and ECG recording, 1 Hz slow-wave auditory stimulation, and cold-induced pain stress (0-2°C bottle contact). The user interface, task instructions, and visual \"energy bar\" display are identical to the real arm. However, in the sham arm the feedback threshold is set near baseline (t≈+0.1), so that bar fluctuations are largely insensitive to actual left DLPFC HbO changes. This preserves the appearance of neurofeedback while preventing participants from achieving genuine volitional control over cortical activity.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Real-time fNIRS-based neurofeedback","Real-time fNIRS-based neurofeedback is a non-invasive brain-computer interface procedure that uses functional near-infrared spectroscopy to monitor cortical haemodynamic activity online and return it as visual feedback. In this trial, an optode montage is placed over the bilateral prefrontal cortex, with the left dorsolateral prefrontal cortex (DLPFC) defined as the target region. Oxygenated haemoglobin (HbO) signals from the left DLPFC are preprocessed in real time and entered into a sliding-window general linear model to generate a task-related test statistic. A sign-inverted version of this statistic is mapped to an on-screen \"energy bar\", such that stronger left DLPFC activation corresponds to a lower bar. Participants are instructed to use self-regulation strategies to push the bar below a preset threshold while exposed to cold-induced pain and 1 Hz slow-wave auditory stimulation, thereby forming a closed loop between prefrontal activation and feedback.",[9,15],null,[27,30],{"name":28,"affiliation":5,"role":29},"Lin Tao, MM","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":5,"role":32},"Yun-En Liu, MD","STUDY_CHAIR",[34],{"name":28,"role":35,"phone":36,"phoneExt":25,"email":37},"CONTACT","86-18802401698","1939908868@qq.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Second Affiliated Hospital of Shenyang Medical College","RECRUITING","Shenyang","Liaoning","110001","China","CN",{"type":48,"coordinates":49},"Point",[50,51],123.43278,41.79222,{"lat":51,"lon":50},[54,58],{"name":55,"role":35,"phone":56,"phoneExt":25,"email":57},"Bo Gao, MD","86-18002453489","m18002453489@163.com",{"name":55,"role":29,"phone":25,"phoneExt":25,"email":25},{"type":29,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Lin Tao","Assoc.Prof.",[63],{"name":64,"class":6},"The Second Hospital of Shenyang Medical College","100611738","closed-loop-neurofeedback-targeting-the-left-dorsolateral-prefrontal-cortex-for-cardiac-autonomic-modulation-in-coronary-artery-disease-with-anxiety-100611738",false,"NCT07244484","Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety","Closed-Loop Neurofeedback Targeting the Left Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety - A Randomized, Sham-Controlled Trial (HEART-SET-2)","HEART-SET-2","Inclusion Criteria:\n\n* Age \\>18 years, any sex.\n* Right-handed, with resting heart rate between 60 and 100 beats per minute.\n* Confirmed diagnosis of CHD, defined as at least one of the following:\n\n  (i) positive stress test; (ii) documented myocardial infarction (MI) with electrocardiographic changes and concurrent elevation of creatine kinase MB isoenzyme or troponin; (iii) angiographically confirmed coronary atherosclerosis with ≥50% stenosis in at least one coronary artery.\n* Diagnosis of an anxiety disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5).\n* Hamilton Anxiety Rating Scale (HAMA) score ≥16 and 17-item Hamilton Depression Rating Scale (HAMD-17) score ≤17.\n\nExclusion Criteria:\n\n* Acute unstable angina.\n* Severe congestive heart failure (New York Heart Association \\[NYHA\\] class IV).\n* Valvular heart disease.\n* History of atrial fibrillation.\n* Unstable blood pressure, defined as systolic blood pressure \\>180 mmHg or \\\u003C90 mmHg.\n* Pregnancy.\n* History of unstable medical conditions, including cerebrovascular disease, dementia, hyperthyroidism, pulmonary disease, or malignancy. These are assessed through medical history, electronic health records, physical examination, and ECG findings.\n* High risk of suicide or homicide.\n* Presence of other psychiatric disorders, including psychotic disorders, bipolar disorder, or active substance use disorders.\n* Use of psychotropic medication within 1 month prior to enrolment, to avoid potential interference with haemodynamic measurements.","ALL","18 Years",{"count":76,"type":77},56,"ESTIMATED","INTERVENTIONAL",[80],"NA","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.\n\nThe main questions it aims to answer are:\n\nDoes real left DLPFC neurofeedback, compared with sham neurofeedback, lead to a greater reduction in baseline-corrected HR during the cold-induced pain stimulation window?\n\nDoes real neurofeedback produce stronger volitional upregulation of left DLPFC activation and higher inter-hemispheric synchronisation between left and right DLPFC than sham neurofeedback?\n\nAre changes in baseline-corrected HR statistically associated with, and partly mediated by, changes in left DLPFC activation or DLPFC inter-hemispheric synchronisation?\n\nWhat adverse events(AEs) occur during adaptive training and the formal experimental session, and do AE rates differ between the two groups?\n\nResearchers 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.\n\nParticipants will:\n\nundergo cardiac and psychiatric screening to confirm stable CHD, DSM-5 anxiety disorder, and other eligibility criteria;\n\nattend 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;\n\non 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.",[83,84],"Coronary Heart Disease (CHD)","Anxiety Disorders",[86,87,88,89],"Coronary heart disease","Anxiety","Neurofeedback","the dorsolateral prefrontal cortex","2026-04-21",{"date":92,"type":93},"2026-04-22","ACTUAL",{"date":95,"type":93},"2025-11-23",{"date":97,"type":77},"2026-05-30",{"name":5,"class":6},1]