[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Shenyang Medical College\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":278},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,47,80,109,136,155,179,207,231,256],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100610876","high-intensity-low-frequency-periodic-rtms-over-the-right-dorsolateral-prefrontal-cortex-on-cardiac-autonomic-regulation-in-women-with-recurrent-pregnancy-loss-and-anxiety-100610876",false,"NCT07233278","High-Intensity, Low-Frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex on Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Anxiety","High-intensity, Low-frequency Periodic rTMS Over the Right Dorsolateral Prefrontal Cortex for Acute Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss and Generalized Anxiety Disorder: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-rTMS-2)","Inclusion Criteria:\n\n* (i) Female, aged 18-45 years, and right-handed;\n* (ii) Diagnosed with recurrent pregnancy loss (RPL), defined as two or more consecutive spontaneous miscarriages occurring before 28 weeks of gestation;\n* (iii) Not currently pregnant or in a state of missed miscarriage;\n* (iv) Meeting the DSM-5 diagnostic criteria for GAD, with a HAMA score of at least 16, a CGI-S score of at least 4, and a HAMD-17 score of no more than 17.\n\nExclusion Criteria:\n\n* (i) Contraindications to transcranial magnetic stimulation (TMS), such as metallic implants or a history of epilepsy;\n* (ii) Unstable blood pressure (systolic \\>180 mmHg or \\\u003C90 mmHg);\n* (iii) Coexisting major organic disorders, including hyperthyroidism, atrial fibrillation, valvular heart disease, sinus bradycardia, neurological diseases, cerebrovascular disease, or pulmonary disorders;\n* (iv) Significant suicide risk;\n* (v) Other current major psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium. To preserve diagnostic homogeneity of the study sample, participants whose current primary diagnosis is another anxiety-related disorder will also be excluded, including panic disorder, social anxiety disorder, separation anxiety disorder, specific phobia, obsessive-compulsive and related disorders, and trauma- and stressor-related disorders; Current use of psychotropic medication at screening, or continuous use within the 4 weeks before screening of antidepressants, anxiolytics, antipsychotics, mood stabilizers, or sedative-hypnotics, in order to minimize hemodynamic confounding.","FEMALE","18 Years","45 Years",{"count":20,"type":21},46,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to determine whether high-intensity, low-frequency periodic repetitive transcranial magnetic stimulation (rTMS) applied to the right dorsolateral prefrontal cortex (DLPFC) can modulate cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety. The main questions it aims to answer are:\n\nDoes 120% resting motor threshold (RMT) rhythmic low-frequency rTMS reduce heart rate during stimulation time windows compared with sham stimulation?\n\nDoes 120% RMT rTMS alter heart-rate-variability (HRV) spectral power at the target frequency (0.0167 Hz) compared with sham stimulation?\n\nResearchers will compare active rTMS with sham rTMS to determine whether the active intervention produces measurable changes in cardiac autonomic activity.\n\nParticipants will:\n\nUndergo a single session of rTMS or sham stimulation consisting of 20 consecutive stimulation time windows (each 60 seconds: 40 seconds of 1-Hz stimulation plus 20 seconds of rest) targeting the right DLPFC;\n\nHave continuous electrocardiography (ECG) recordings collected during the entire stimulation session;\n\nComplete clinical and psychiatric assessments before participation.",[27,28],"Recurrent Pregnancy Loss(RPL)","Anxiety",[30,28,31,32,33],"Recurrent pregnancy loss","Dorsolateral Prefrontal Cortex","Cardiac Autonomic Regulation","repetitive transcranial magnetic stimulation","RECRUITING","2026-06-02",{"date":37,"type":38},"2026-06-03","ACTUAL",{"date":40,"type":38},"2025-11-17",{"date":42,"type":21},"2026-12-30",{"name":44,"class":45},"Shenyang Medical College","OTHER",3,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},"100636149","effects-of-high-frequency-left-dorsolateral-prefrontal-rtms-on-heart-brain-coupling-in-women-with-recurrent-pregnancy-loss-and-elevated-bmi-100636149","NCT07561931","Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI","Effects of High-frequency Left Dorsolateral Prefrontal rTMS on Heart-brain Coupling in Women With Recurrent Pregnancy Loss and Elevated BMI: a Randomized, Sham-controlled Mechanistic Trial (NEURO-CARD-BMI)","NEURO-CARD-BMI","Inclusion Criteria:\n\n* 1.Female participants aged 18-45 years and right-handed.\n* 2.Fulfillment of the prespecified definition of recurrent pregnancy loss in this study, defined as at least two consecutive spontaneous miscarriages occurring before 28 weeks of gestation.\n* 3.BMI ≥24 kg\u002Fm², classified as overweight or obesity according to the Chinese adult criteria for overweight and obesity.\n* 4.Currently not pregnant and in a clinically stable condition. If there is a recent history of missed abortion, appropriate management must have been completed and obstetric assessment must confirm the absence of acute vaginal bleeding, infection, marked abdominal pain, or hemodynamic instability.\n* 5.Ability to understand the study procedures, provide written informed consent, and cooperate with scale assessment, transcranial magnetic stimulation safety screening, and the single-session rTMS-ECG protocol.\n\nExclusion Criteria:\n\n* 1.Presence of contraindications to transcranial magnetic stimulation or elevated seizure risk, including but not limited to epilepsy or a history of unexplained seizures, intracranial ferromagnetic metal implantation, or the presence of electronic or metallic implanted devices within 30 cm of the coil that are judged unsuitable for transcranial magnetic stimulation.\n* 2.Current pregnancy.\n* 3.Hemodynamic instability or cardiovascular abnormalities that may substantially affect interpretation of the primary endpoint, including systolic blood pressure \\>180 mmHg or \\\u003C90 mmHg, atrial fibrillation or other clinically significant arrhythmias, valvular heart disease, marked sinus bradycardia, symptomatic coronary artery disease, or other cardiovascular conditions judged by the research team to make participation unsuitable.\n* 4.Uncontrolled major medical or neurologic disorders, particularly those that may substantially affect autonomic state, ECG recording, or interpretation of the primary endpoint, including uncontrolled thyroid dysfunction, uncontrolled diabetes mellitus, significant cerebrovascular disease, neurologic disorders, or active pulmonary disease.\n* 5.Presence of significant suicide risk.\n* 6.Severe psychiatric disorders that may affect study safety or adherence, including schizophrenia spectrum disorders, bipolar disorder during a manic or hypomanic episode, delirium, and active substance use disorder.\n* 7.Severe anxiety or severe depression, defined as a Hamilton Anxiety Rating Scale total score of ≥25 or a 17-item Hamilton Depression Rating Scale total score of ≥24.\n* 8.Recent medication-related confounding risk, including current withdrawal from alcohol, sedative-hypnotics, or other relevant substances, or initiation, discontinuation, or dose adjustment within the preceding 2 weeks of medications that may substantially affect seizure threshold, autonomic function, ECG-related indices, or interpretation of the primary endpoint.\n* 9.Any other condition judged by the research team to make participation inappropriate.",{"count":56,"type":21},60,[24],"This randomized, sham-controlled mechanistic trial will examine whether a single session of high-frequency repetitive transcranial magnetic stimulation, rTMS, applied to the left dorsolateral prefrontal cortex can modify heart-brain coupling in women with recurrent pregnancy loss and elevated body mass index, BMI. Women with recurrent pregnancy loss often experience reproductive, metabolic, and emotional stress at the same time, and this combined vulnerability may be associated with altered autonomic regulation and exaggerated cardiac responses to stress. The left dorsolateral prefrontal cortex is a key brain region involved in cognitive control, emotion regulation, and top-down modulation of autonomic function.\n\nEligible participants will be randomly assigned in a 1:1 ratio to receive either real or sham rTMS at the same left dorsolateral prefrontal target. The stimulation protocol will use 10 Hz rTMS at 100% motor threshold, delivered in 30 cycles of 5 s stimulation followed by 11 s inter-train interval, with simultaneous 3-lead electrocardiography recording. The primary endpoint will be the between-group difference in mean heart-brain coupling across 30 stimulation cycles. Safety and tolerability will also be monitored. This study is intended to provide mechanistic evidence and methodological support for future multi-session randomized trials in this population.",[60,61,62],"Recurrent Pregnancy Loss","Overweight , Obesity","Heart-Brain Coupling",[64,65,66,67,33,68,69],"recurrent pregnancy loss","elevated BMI","overweight","heart-brain coupling","left dorsolateral prefrontal cortex","autonomic regulation","NOT_YET_RECRUITING","2026-04-24",{"date":73,"type":38},"2026-05-01",{"date":75,"type":21},"2026-04-28",{"date":77,"type":21},"2026-09-30",{"name":44,"class":45},1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":88,"targetDuration":4,"studyType":22,"phases":90,"briefSummary":91,"conditions":92,"keywords":93,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},"100617957","cardiac-autonomic-and-anxiety-regulation-via-closed-loop-neurofeedback-in-recurrent-pregnancy-loss-100617957","NCT07325370","Cardiac Autonomic and Anxiety Regulation Via Closed-loop nEurofeedback in Recurrent Pregnancy Loss","Right Dorsolateral Prefrontal Cortex-Targeted fNIRS-BCI Closed-loop Neurofeedback for Anxiety Relief and Cardiac Autonomic Regulation in Women With Recurrent Pregnancy Loss: a Randomized, Sham-controlled Clinical Trial","CARE-RPL","Inclusion Criteria:\n\n* (i) Women aged 18-45 years, right-handed;\n* (ii) Diagnosis of recurrent pregnancy loss (RPL), defined as ≥2 consecutive spontaneous pregnancy losses occurring before 28 weeks of gestation;\n* (iii) Not currently pregnant, or currently in a missed miscarriage state;\n* (iv) Meet DSM-5 diagnostic criteria for an anxiety disorder, with at least moderate severity, defined as Clinical Global Impression-Severity (CGI-S) ≥4;\n* (v) Hamilton Anxiety Rating Scale (HAMA) ≥16, with 17-item Hamilton Depression Rating Scale (HAMD-17) \\\u003C17, to ensure anxiety is the predominant affective disturbance.\n\nExclusion Criteria:\n\n* (i) Markedly unstable blood pressure (systolic BP \\>180 mmHg or \\\u003C90 mmHg);\n* (ii) Clinically important comorbid organic diseases, including but not limited to hyperthyroidism, history of atrial fibrillation, sinus bradycardia, major neurological disorders, cerebrovascular disease, or severe pulmonary disease;\n* (iii) Significant suicide risk, judged by psychiatric assessment to be unsuitable for study participation;\n* (iv) Other severe psychiatric disorders, including substance use disorder, schizophrenia, delusional disorder, unspecified psychotic disorder, bipolar disorder, or delirium;\n* (v) Use of any oral antidepressant, anxiolytic, or antipsychotic medication within the past 4 weeks, or fluoxetine within the past 6 weeks, or any long-acting injectable antipsychotic within the past 3 months.",{"count":89,"type":21},62,[24],"The goal of this clinical trial is to learn whether right dorsolateral prefrontal cortex (right DLPFC)-targeted fNIRS-BCI online closed-loop neurofeedback, delivered with slow-wave acoustic cueing, can reduce anxiety symptoms and improve cardiac autonomic regulation in women with recurrent pregnancy loss (RPL) and comorbid anxiety (women aged 18-45 years, right-handed, currently not pregnant or in a missed miscarriage state).\n\nThe main questions it aims to answer are:\n\nDoes real neurofeedback increase the proportion of participants who achieve an anxiety treatment response (defined as ≥50% reduction in Hamilton Anxiety Rating Scale \\[HAMA\\] total score from baseline) compared with sham feedback, at end of treatment and at 3-month follow-up? Is the intervention safe and well tolerated, as reflected by between-group differences in adverse events during the training period? Do brain and autonomic measures show between-group differences during the first formal session, including right DLPFC HbO downregulation, interhemispheric DLPFC synchronisation, heart rate (HR), and heart rate variability (HRV) indices? Researchers will compare real right DLPFC neurofeedback to sham feedback (identical procedures and displays but weakened coupling to real-time neural activity) to see if real neurofeedback improves anxiety outcomes and brain-heart autonomic regulation.\n\nParticipants will:\n\nComplete screening, baseline clinical assessments, and physical examination Be randomly assigned (1:1) to real neurofeedback or sham feedback Complete 3 days of adaptation training followed by 3 weeks of training (15 sessions; one weekday session per day; \\~20 minutes each) using a block design with slow-wave acoustic cueing (1 Hz amplitude-modulated tone; 20 s rest + 40 s cueing per block; 20 blocks\u002Fsession) Undergo fNIRS recording in all sessions, with ECG recorded in session 1 only (for HR\u002FHRV analyses) Receive matched, guideline-informed cognitive-behavioural therapy (CBT) during the intervention period Complete anxiety-related assessments at baseline, \\~1 hour after the final session, and 3 months after treatment, with adverse events monitored throughout the intervention period",[60,28],[30,94,95,96,97,98,99,100],"Anxiety disorders","Right dorsolateral prefrontal cortex","Functional near-infrared spectroscopy","Brain-computer interface","Closed-loop neurofeedback","Cardiac autonomic function","Brain-heart coupling","2026-04-21",{"date":71,"type":38},{"date":104,"type":38},"2025-12-29",{"date":106,"type":21},"2026-10-30",{"name":44,"class":45},2,{"id":110,"slug":111,"hasResults":11,"nctId":112,"briefTitle":113,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":22,"phases":120,"briefSummary":121,"conditions":122,"keywords":125,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":79},"100611310","closed-loop-neurofeedback-targeting-the-right-dorsolateral-prefrontal-cortex-for-cardiac-autonomic-modulation-in-coronary-artery-disease-with-anxiety-100611310","NCT07238920","Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety","Closed-Loop Neurofeedback Targeting the Right Dorsolateral Prefrontal Cortex for Cardiac Autonomic Modulation in Coronary Artery Disease With Anxiety - A Randomized, Sham-Controlled Trial","HEART-SET-1","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",{"count":119,"type":21},56,[24],"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.\n\nThe main questions it aims to answer are:\n\nDoes 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\u002F60 Hz) and produce stronger suppression of right DLPFC activation? Does suppression of right DLPFC activation mediate the effect of group assignment on heart rate?\n\nIf 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.\n\nParticipants will:\n\nComplete eligibility screening in cardiology and psychiatry and provide informed consent; baseline demographics, medical history, vital signs, and medications are recorded (HAMA\u002FHAMD used for eligibility only).\n\nUndergo 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.\n\nAttend 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.\n\nUndergo 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.",[123,124],"Coronary Heart Disease (CHD)","Anxiety Disorders",[126,28,127,128],"Coronary heart disease","Neurofeedback","Heart rate variability",{"date":130,"type":38},"2026-04-22",{"date":132,"type":38},"2025-11-19",{"date":134,"type":21},"2026-08-21",{"name":44,"class":45},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":4,"enrollmentInfo":143,"targetDuration":4,"studyType":22,"phases":144,"briefSummary":145,"conditions":146,"keywords":147,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":149,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":79},"100611738","closed-loop-neurofeedback-targeting-the-left-dorsolateral-prefrontal-cortex-for-cardiac-autonomic-modulation-in-coronary-artery-disease-with-anxiety-100611738","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",{"count":119,"type":21},[24],"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.",[123,124],[126,28,127,148],"the dorsolateral prefrontal cortex",{"date":130,"type":38},{"date":151,"type":38},"2025-11-23",{"date":153,"type":21},"2026-05-30",{"name":44,"class":45},{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":4,"eligibilityCriteria":161,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":162,"enrollmentInfo":163,"targetDuration":4,"studyType":22,"phases":165,"briefSummary":166,"conditions":167,"keywords":170,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":174,"startDateStruct":175,"completionDateStruct":177,"leadSponsor":178,"locationsCount":79},"100608169","efficacy-and-safety-of-cold-atmospheric-plasma-combined-with-endovascular-intervention-for-diabetic-foot-ulcers-with-lower-extremity-arterial-occlusion-100608169","NCT07198061","Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion","Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention for Diabetic Foot Ulcers With Lower Extremity Arterial Occlusion: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* 1)Age between 18 and 80 years; diagnosed with type 1 or type 2 diabetes mellitus; with HbA1c ≤10%;\n* 2)Presence of at least one chronic foot ulcer persisting for ≥3 weeks, with no signs of healing despite guideline-directed standard care; ulcer classified as Wagner-Armstrong grade 1D or 2D;\n* 3)Imaging-confirmed infrapopliteal arterial stenosis or occlusion, assessed by vascular ultrasound and\u002For computed tomography angiography (CTA); all patients must have undergone infrapopliteal balloon angioplasty, with successful target vessel revascularisation confirmed intraoperatively (≤30% residual stenosis);\n* 4)Signed written informed consent prior to study participation.\n\nExclusion Criteria:\n\n* 1)Concurrent use of negative pressure wound therapy (NPWT) or maggot debridement therapy;\n* 2)Undergoing dialysis for end-stage renal disease;\n* 3)Use of topical antibiotics with known biological activity on the wound;\n* 4)Use of platelet-rich fibrin (PRF) for wound treatment;\n* 5)Women of childbearing potential without effective contraception, or currently breastfeeding;\n* 6)Presence of severe comorbidities involving other organ systems, with an estimated life expectancy of less than 6 months;\n* 7)Participation in another clinical trial within the past 3 months, or currently enrolled in another clinical study;\n* 8)Any condition deemed unsuitable for trial participation at the discretion of the investigators.","80 Years",{"count":164,"type":21},40,[24],"The goal of this clinical trial is to evaluate whether cold atmospheric plasma (CAP) combined with endovascular intervention can accelerate wound healing and improve safety outcomes in patients aged 18 to 80 years with diabetic foot ulcers (DFUs) complicated by lower extremity arterial occlusion.\n\nThe main questions it aims to answer are:\n\n1. Does CAP treatment lead to a greater reduction in ulcer area by Week 4 compared to placebo?;\n2. Is CAP therapy safe and well-tolerated in patients with DFUs after successful infrapopliteal revascularisation?;\n\nResearchers will compare CAP treatment plus standard care to sham CAP (placebo) plus standard care to see if CAP improves wound healing more effectively and reduces adverse local symptoms.\n\nParticipants will:\n\n1. Receive either active CAP therapy or sham CAP therapy once daily for 10 days following endovascular revascularisation\n2. Undergo daily wound assessments for ulcer area, signs of infection, and pain scores\n3. Complete quality-of-life questionnaires (EQ-5D and SF-12) at baseline and Week 4\n4. Be followed through Week 4 to assess efficacy and safety endpoints",[168,169],"Diabetic Foot Ulcers (DFU)","Lower Extremity Arterial Occlusion",[171,172,173],"Cold Atmospheric Plasma","Diabetic Foot Ulcers","lower extremity arterial occlusion",{"date":130,"type":38},{"date":176,"type":38},"2025-10-09",{"date":42,"type":21},{"name":44,"class":45},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":185,"eligibilityCriteria":186,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":195,"overallStatus":70,"whyStopped":4,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":202,"completionDateStruct":204,"leadSponsor":206,"locationsCount":79},"100634707","right-dorsolateral-prefrontal-cortex-closed-loop-neurofeedback-for-anxiety-in-high-ischaemic-risk-chronic-coronary-syndrome-100634707","NCT07543185","Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome","Right Dorsolateral Prefrontal Cortex Closed-loop Neurofeedback for Anxiety in High-ischaemic-risk Chronic Coronary Syndrome: a Randomized, Sham-controlled Trial","HEART-SET-3","Inclusion Criteria:\n\n* Participants will be aged 18 years or older and will provide written informed consent.\n* Participants will have chronic coronary syndrome (CCS) with prior coronary stent implantation more than 6 months before enrollment.\n* Participants will meet high ischemic risk (HIR) criteria by either of the following:\n\n  * Percutaneous coronary intervention (PCI) performed more than 6 months earlier for acute coronary syndrome (ACS), including unstable angina, non-ST-segment elevation myocardial infarction, or ST-segment elevation myocardial infarction, with implantation of at least 1 coronary stent; or\n  * PCI performed more than 6 months earlier for a non-ACS indication, together with at least 1 of the following risk factors:\n\n    * diabetes mellitus;\n    * diffuse multivessel coronary artery disease involving all 3 major coronary vessels;\n    * chronic kidney disease with creatinine clearance less than 50 mL\u002Fmin (recommended to be calculated using the Cockcroft-Gault formula);\n    * prior stent thrombosis;\n    * peripheral arterial disease;\n    * complex PCI, defined by at least 1 of the following:\n\n      * only patent remaining coronary vessel or left main coronary artery stenting;\n      * implantation of at least 3 stents or treatment of at least 3 lesions;\n      * bifurcation lesion treated with a 2-stent strategy;\n      * total stent length greater than 60 mm;\n      * PCI for chronic total occlusion.\n* Participants will meet DSM-5 diagnostic criteria for an anxiety disorder, confirmed by structured psychiatric interview.\n* Participants will have a Hamilton Anxiety Rating Scale (HAMA) score of 16 or higher.\n* Participants will have a 17-item Hamilton Depression Rating Scale (HAMD-17) score lower than 17.\n* Participants will not have used psychotropic medication, including antidepressants, anxiolytics, or antipsychotics, within 1 month before enrollment; prior psychotropic medication use will not itself exclude participation, provided that a washout period has been completed before enrollment and the medication history is documented.\n\nExclusion Criteria:\n\n* Participants will be excluded if they have severe congestive heart failure (New York Heart Association class IV).\n* Participants will be excluded if they have moderate-to-severe valvular heart disease.\n* Participants will be excluded if they have a history of atrial fibrillation.\n* Participants will be excluded if they have unstable blood pressure, defined as systolic blood pressure greater than 180 mmHg or less than 90 mmHg.\n* Participants will be excluded if they are pregnant or breastfeeding.\n* Participants will be excluded if they have active or recent (within 6 months) severe systemic disease, including any of the following:\n\n  * cerebrovascular disease, including stroke or transient ischemic attack;\n  * dementia or severe cognitive impairment;\n  * hyperthyroidism;\n  * active pulmonary disease;\n  * active malignant tumor.\n* Participants will be excluded if they have suicidal or homicidal risk based on clinical interview.\n* Participants will be excluded if they have other severe psychiatric disorders, including but not limited to:\n\n  * psychotic disorders, such as hallucinations or delusions;\n  * bipolar disorder.",{"count":188,"type":21},214,[24],"This study is a prospective, randomized, sham-controlled, participant- and assessor-blinded, parallel-group clinical trial designed to evaluate the clinical efficacy, mechanistic effects, and safety of right dorsolateral prefrontal cortex (DLPFC) closed-loop functional near-infrared spectroscopy brain-computer interface (fNIRS-BCI) neurofeedback in patients with high-ischaemic-risk chronic coronary syndrome (CCS) and comorbid anxiety disorder. Participants will be randomly assigned in a 1:1 ratio to active neurofeedback or sham feedback. The intervention consists of 4 weeks of treatment, with 20 sessions in total (1 session per weekday, approximately 20 minutes per session). The primary endpoint is the between-group difference in Hamilton Anxiety Rating Scale (HAMA) score at 3 months after treatment. Secondary endpoints include HAMA score and HAMA response rate at the end of treatment, as well as neurophysiological measures collected during Session 1, including right DLPFC activation, heart rate (HR), and heart rate variability (HRV). Exploratory long-term follow-up will assess cardiovascular and bleeding outcomes through 4 years after randomization.",[192,193,194],"Chronic Coronary Syndrome","Anxiety Disorder","High Ischemic Risk",[196,197,198,199],"closed-loop neurofeedback","fNIRS-BCI","right dorsolateral prefrontal cortex","psycho-cardiology","2026-04-14",{"date":101,"type":38},{"date":203,"type":21},"2026-04-19",{"date":205,"type":21},"2031-02-20",{"name":44,"class":45},{"id":208,"slug":209,"hasResults":11,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":162,"enrollmentInfo":215,"targetDuration":4,"studyType":22,"phases":217,"briefSummary":218,"conditions":219,"keywords":220,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":223,"lastUpdatePostDateStruct":224,"startDateStruct":226,"completionDateStruct":228,"leadSponsor":230,"locationsCount":79},"100598557","efficacy-and-safety-of-cold-atmospheric-plasma-combined-with-endovascular-intervention-in-patients-with-diabetic-foot-ulcers-and-lower-extremity-arterial-occlusion-100598557","NCT07073040","Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention in Patients With Diabetic Foot Ulcers and Lower Extremity Arterial Occlusion","Efficacy and Safety of Cold Atmospheric Plasma Combined With Endovascular Intervention in Patients With Diabetic Foot Ulcers and Lower Extremity Arterial Occlusion: a Randomized, Double-blind, Placebo-controlled Clinical Trial","PROSPECT","Inclusion Criteria:\n\n* Aged 18-80 years, with a diagnosis of type 1 or type 2 diabetes and diabetic foot ulcer; glycated hemoglobin (HbA1c) ≤ 10%.\n* Presence of at least one chronic foot ulcer persisting for at least three weeks, with no signs of healing after standard-of-care treatment based on current clinical guidelines. The ulcer must be classified as Wagner-Armstrong grade 1D or 2D (Wagner: superficial ulcer \\[grade 1\\] or ulcer extending to tendon \\[grade 2\\]; Armstrong: presence of both ischaemia and infection \\[stage D\\]).\n* Documented infrapopliteal arterial stenosis or occlusion by vascular ultrasound and\u002For CT angiography (CTA), meeting indications for revascularization. All enrolled patients must have received successful infrapopliteal balloon angioplasty, with intraoperative angiography confirming target artery patency.\n* Provision of written informed consent.\n\nExclusion Criteria:\n\n* Concurrent treatment of the wound with local vacuum therapy or maggot therapy.\n* Undergoing dialysis.\n* Use of local active antibiotics.\n* Treatment with platelet-rich fibrin.\n* Women of childbearing potential without effective contraception, or women who are actively breastfeeding.\n* Presence of other severe organ dysfunction, with an expected survival of less than six months.\n* Participation in another clinical trial within the past three months or currently enrolled in another clinical trial.",{"count":216,"type":21},86,[24],"Critical limb ischemia is the end-stage manifestation of peripheral arterial disease (PAD), frequently presenting as ischemic rest pain, ulceration, or gangrene. Diabetes mellitus is a major risk factor for lower extremity arterial occlusion, with infrapopliteal arteries most commonly affected. Patients with diabetic foot ulcers (DFUs) have a high prevalence of neurovascular complications, poor healing, and elevated amputation and mortality rates. Large-scale cohort studies indicate that five-year survival after amputation in this population is only about 50%, underscoring the need for more effective therapies.\n\nEndovascular revascularization has become the first-line treatment for diabetic lower limb ischemia. However, despite successful revascularization, persistent microvascular dysfunction and difficult-to-heal ulcers remain common due to chronic inflammation, impaired angiogenesis, and tissue repair deficits. Current advanced wound dressings provide limited benefit and are often costly.\n\nCold atmospheric plasma (CAP) has emerged as a promising adjunctive therapy, with demonstrated antimicrobial activity-including efficacy against multidrug-resistant organisms-and the ability to promote microcirculation and wound healing. CAP generates reactive oxygen and nitrogen species that disrupt bacterial membranes and may also stimulate tissue regeneration. Preclinical and clinical studies suggest that CAP can accelerate healing in chronic wounds and is well tolerated by patients.\n\nGiven these advantages, the present study aims to assess the efficacy and safety of CAP combined with endovascular intervention in patients with diabetic foot ulcers and lower extremity arterial occlusion, to inform future clinical application of this novel technology.",[168,169],[221,222,173],"cold atmospheric plasma","diabetic foot ulcers","2026-01-29",{"date":225,"type":38},"2026-01-30",{"date":227,"type":38},"2025-07-22",{"date":229,"type":21},"2026-05-06",{"name":44,"class":45},{"id":232,"slug":233,"hasResults":11,"nctId":234,"briefTitle":235,"officialTitle":236,"acronym":4,"eligibilityCriteria":237,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":238,"enrollmentInfo":239,"targetDuration":4,"studyType":22,"phases":241,"briefSummary":242,"conditions":243,"keywords":245,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":249,"startDateStruct":251,"completionDateStruct":253,"leadSponsor":255,"locationsCount":79},"100597297","atmospheric-pressure-cold-plasma-for-moderate-to-severe-tinea-pedis-100597297","NCT07056660","Atmospheric Pressure Cold Plasma for Moderate-to-severe Tinea Pedis","Efficacy and Safety of Atmospheric Pressure Cold Plasma in the Treatment of Moderate-to-severe Tinea Pedis: a Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Clinical Trial","Inclusion Criteria:\n\n* Age between 18 and 70 years, irrespective of sex.\n* Clinical diagnosis of interdigital tinea pedis (non-hyperkeratotic type), with or without extension to other areas, of moderate to severe intensity, defined as follows: target lesion(s) will have an erythema score of ≥2 and either a desquamation or pruritus score of ≥2, with a total score ≥4 (using a 0-3 scale for each item).\n* Positive direct potassium hydroxide (KOH) microscopic examination for dermatophytes.\n* Women of childbearing potential will agree to use effective contraception throughout the study period.\n* Written informed consent will be obtained prior to enrollment.\n\nExclusion Criteria:\n\n* Severe bacterial infection or other dermatological conditions that may interfere with study assessments.\n* Serious cardiac, hepatic, or renal diseases, diabetes mellitus, or major psychiatric disorders.\n* Systemic corticosteroid or immunosuppressant use within the past 3 months.\n* Systemic antifungal agents within the past 2 months or topical antifungal agents within the past 2 weeks.\n* Pregnancy or breastfeeding.","70 Years",{"count":240,"type":21},220,[24],"Tinea pedis (athlete's foot) is a common and highly contagious fungal infection of the feet. Moderate-to-severe cases present with extensive skin lesions, severe symptoms, frequent recurrences, and increased risk of complications, often proving refractory to conventional topical therapies. Anatomical niches, poor drug penetration, and antifungal resistance make effective management challenging and negatively impact patients' quality of life.\n\nCurrent treatments, including topical and systemic antifungals or physical modalities, are often limited by incomplete efficacy, complexity, or poor adherence. Therefore, more effective and practical treatment options are urgently needed.\n\nAtmospheric pressure cold plasma (CAP) is an innovative technology that generates reactive species capable of targeting pathogens while preserving normal tissue. CAP has demonstrated strong antimicrobial effects and promotes wound healing in biomedical research. This study will evaluate the efficacy and safety of CAP in treating moderate-to-severe tinea pedis, aiming to address unmet clinical needs and support future clinical application.",[244],"Tinea Pedis",[246,247],"Tinea pedis","Atmospheric pressure cold plasma","2025-12-30",{"date":250,"type":38},"2026-01-02",{"date":252,"type":38},"2025-07-25",{"date":254,"type":21},"2026-08-20",{"name":44,"class":45},{"id":257,"slug":258,"hasResults":11,"nctId":259,"briefTitle":260,"officialTitle":261,"acronym":4,"eligibilityCriteria":262,"healthyVolunteers":11,"sex":117,"minAge":17,"maxAge":263,"enrollmentInfo":264,"targetDuration":4,"studyType":22,"phases":265,"briefSummary":266,"conditions":267,"keywords":269,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":248,"lastUpdatePostDateStruct":272,"startDateStruct":273,"completionDateStruct":275,"leadSponsor":277,"locationsCount":79},"100597298","cold-atmospheric-plasma-for-moderate-to-severe-acne-vulgaris-study-100597298","NCT07056673","Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris Study","Efficacy and Safety of Cold Atmospheric Plasma for Moderate-to-severe Acne Vulgaris: a Multicentre, Randomised, Double-blind, Placebo-controlled Clinical Trial","Inclusion Criteria:\n\n* Aged 18-40 years;\n* Clinically diagnosed with acne vulgaris, with moderate to severe disease (Pillsbury grade III or IV, lesion count ≥50);\n* Will agree to use effective contraception during the treatment period;\n* Will sign a written informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women;\n* Known allergy to any active component of CAP;\n* Use of systemic antibiotics within 4 weeks prior to enrollment;\n* Presence of dyslipidemia or other severe systemic diseases;\n* Participation in other clinical trials within the past 3 months or currently enrolled in another clinical trial.","40 Years",{"count":240,"type":21},[24],"Acne vulgaris is a common, chronic inflammatory skin disease with complex pathogenesis and limited therapeutic options, especially for moderate-to-severe cases. Standard treatments-including topical and oral agents-are often constrained by side effects, antimicrobial resistance, and treatment resistance. Cold atmospheric plasma (CAP), a novel technology that generates reactive oxygen and nitrogen species, has demonstrated antimicrobial and tissue-regenerative properties in dermatology, but robust clinical evidence in acne management remains scarce. Existing data suggest promising efficacy and safety, yet its use in moderate-to-severe acne vulgaris has not been adequately investigated. This study aims to evaluate the efficacy and safety of two self-developed CAP devices as a potential innovative therapy for moderate-to-severe acne vulgaris.",[268],"Acne Vulgaris",[270,271],"Acne vulgaris","Cold atmospheric plasma",{"date":250,"type":38},{"date":274,"type":38},"2025-07-26",{"date":276,"type":21},"2026-12-20",{"name":44,"class":45},""]