[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"post-stroke-depression\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:post-stroke-depression":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,42,69,97,117,143,171,191,219,244,270,290,313,333,351],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100582546","behavioral-activation-for-the-prevention-of-post-stroke-depression-in-low-income-older-stroke-survivors-100582546",false,"NCT06864715","Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors","Behavioral Activation for the PreVention of Post-strokE Depression in LoW-incomE Older Stroke Survivors (LIVE-WEL)","LIVE-WEL","Inclusion Criteria:\n\n* Enrollment within 3-months +2 weeks of a first-time ischemic or hemorrhagic stroke\n* 24-item HDRS score \\\u003C 15 indicating subthreshold depression defined as the absence of depressive symptoms or presence of mild symptoms of depression\n* Single person income less than or equal to $45,000\n* Residing in a community residence\n* Ability to speak and read in English or Spanish\n* Mini-MoCA score \\> or equal to 11\n\nExclusion Criteria:\n\n* Stroke event unrelated to vascular risk factors (e.g., drug use) or transient ischemic attack\n* 24-item HDRS score \\> or equal to 15 indicating moderate to severe depression\n* Actively participating in psychotherapy\n* high suicide risk or severe psychiatric illness (e.g., bipolar disorder and active psychosis) and\u002For actively taking antipsychotics\n* Diagnosed dementia and\u002For currently taking cognitive enhancers, amyloid-targeting medications, or orexin receptor antagonists\n* Patient Health Questionnaire 9 score \\> or equal to 10 and\u002For answers positive to Q9\n* Diagnosed aphasia and\u002For severe cognitive impairments\n* high-risk alcohol or drug misuse\n* receiving medications for mood disorders and a change in dose or type within the last 4 weeks","ALL","55 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"NA","The overall objective of the project is to determine the effectiveness of tele-delivered behavioral activation (BA) by trained lay counselors (Tele-BA-S) to prevent Post-stroke depression (PSD) in low-income, older stroke survivors with subthreshold depression (SD).",[27,28],"Post-stroke Depression","Subthreshold Depression","RECRUITING","2026-04-22",{"date":32,"type":33},"2026-04-28","ACTUAL",{"date":35,"type":33},"2026-04-10",{"date":37,"type":21},"2029-11-01",{"name":39,"class":40},"The University of Texas Health Science Center, Houston","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":41},"100625487","hyperbaric-oxygen-therapy-for-persistent-post-stroke-depression-100625487","NCT07423273","Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression","Hyperbaric Oxygen Therapy for Persistent Post Stroke Depression: A Prospective, Randomized, Double Blind Study","Inclusion Criteria:\n\n1. Age between 50 -85\n2. Suffered an ischemic stroke 6 months to 7 years prior to their inclusion\n3. Treated or being treated by antidepressants for at least 3 months\n4. Diagnosis of PSD based on HDRS-17 score of 17 and above.\n5. Stable psychological and pharmacological treatment for more than three months prior to inclusion.\n6. Subject willing and able to read, understand and sign an informed consent.\n\nExclusion Criteria:\n\n1. Inability to attend scheduled clinic visits and\u002For comply with the study protocol\n2. Diagnosis of a psychiatric disorder prior to the recent stroke including: major depression, schizophrenia or bipolar disease.\n3. Diagnosis of aphasia or major cognitive decline\n4. History of Deep brain stimulation (DBS)\n5. History of traumatic brain injury, brain tumors, brain surgery, chronic subdural haemorrhages, Epilepsy\n6. Active malignancy\n7. Substance use at baseline.\n8. History of other neurodegenerative diseases including Alzheimer's disease (AD), Parkinson's disease (PD), Lewy body dementia (LBD), Frontotemporal dementia (FTD), Multiple sclerosis (MS), Amyotrophic lateral sclerosis (ALS), Creutzfeld Jacob disease (CJD), Multisystem atrophy (MSA), Pseudobulbar palsy (PSP), Corticobasal degeneration (CBD), Wernicke Korsakoff syndrome\n9. Serious suicidal ideation\n10. Renal or liver insufficiency, electrolyte imbalances\n11. Chronic heart failure with ejection fraction of 30 or less\n12. HBOT for any reason prior to study enrolment\n13. Chest pathology incompatible with pressure changes (including active asthma or COPD)\n14. Ear or Sinus pathology incompatible with pressure changes (above 3 otolaryngologist visits a year)\n15. An inability to perform an awake brain MRI\n16. No evidence of vascular related lesions in the brain MRI\n17. Active smoking\n18. Participation in another study","50 Years","85 Years",{"count":52,"type":21},142,[24],"The study evaluates the effect of HBOT on depression in patients suffering from persistent symptoms of post stroke depression (PSD) in an double blind sham control study.",[56],"Post Stroke Depression",[58],"hyperbaric oxygen therapy","2026-04-16",{"date":61,"type":33},"2026-04-17",{"date":63,"type":33},"2023-11-08",{"date":65,"type":21},"2030-12-01",{"name":67,"class":68},"Assaf-Harofeh Medical Center","OTHER_GOV",{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":77,"enrollmentInfo":78,"targetDuration":4,"studyType":22,"phases":80,"briefSummary":81,"conditions":82,"keywords":83,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":4},"100625446","intervention-study-of-virtual-reality-based-mindfulness-based-cognitive-therapy-vr-mbct-combined-with-adaptive-tdcs-modulation-for-post-stroke-depression-100625446","NCT07422740","Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression","Intervention Study of Virtual Reality-Based Mindfulness-Based Cognitive Therapy (VR-MBCT) Combined With Adaptive tDCS Modulation for Post-Stroke Depression：A Randomized Controlled Trial","Inclusion Criteria:\n\n1. Aged 18 to 65 years (inclusive).\n2. Stroke onset ≥ 4 weeks, with stable condition and an NIHSS score ≤ 15.\n3. Right-handed.\n4. Patient must be in a depressive episode, defined by a PHQ-9 score ≥ 5 and confirmed by a HDRS-24 score ≥ 8.\n5. Has not used any antidepressants before the enrollment.\n6. No contraindications to tDCS (e.g., metal plates in the head, brain implants, aneurysm clips, cochlear implants, cardiac pacemakers, etc.).\n7. Has not received systematic psychotherapy (such as MBCT, mindfulness training, or cognitive behavioral therapy) for the current or previous depressive episodes.\n8. Has more than 8 years of formal education.\n9. Has not received tDCS or other transcranial electrical stimulation treatment for the current or previous depressive episodes.\n10. Is able to cooperate with multimodal MRI data collection and follow-up assessments, and can understand and comply with the study requirements.\n\nExclusion Criteria:\n\n1. History of treatment-resistant depression, defined as failure to respond to at least two different antidepressant medications of adequate dosage and duration (at least 8 weeks at the maximum recommended therapeutic dose).\n2. Other psychiatric diagnoses (e.g., intellectual disability, schizophrenia, affective psychosis, bipolar disorder, obsessive-compulsive disorder, attention deficit hyperactivity disorder, eating disorders, personality disorders, substance use disorders, post-traumatic stress disorder, panic disorder, or social phobia). Co-morbid anxiety disorder is acceptable.\n3. Baseline Mini-Mental State Examination (MMSE) score ≤ 24.\n4. Presence of suicidal ideation or plan within 4 weeks prior to baseline.\n5. Depressive symptoms are better explained by another clinical condition (e.g., hypothyroidism, anemia, congestive heart failure) or other mental disorders.\n6. Presence of severe, unstable cardiovascular, hepatic, renal, hematological, endocrine diseases, or malignancies.\n7. Laboratory tests indicating significant impairment: total bilirubin (TBIL) \\> 1.5 times the upper limit of normal (ULN); alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 times ULN; glomerular filtration rate (GFR) ≤ 70 mL\u002Fmin; or thyroid-stimulating hormone (TSH) outside the normal range.\n8. Poorly controlled hypertension (sitting systolic blood pressure (SBP) ≥ 180 mmHg or sitting diastolic blood pressure (DBP) ≥ 110 mmHg at screening or baseline).\n9. Epilepsy and\u002For other neurological diseases (e.g., dementia, traumatic brain injury, Parkinson's disease, Huntington's disease, multiple sclerosis), or any neurological condition leading to increased intracranial pressure, brain damage, or increased risk of seizures.\n10. Pregnant, lactating, or planning pregnancy.\n11. Significant visual or hearing impairment that prevents participation in interventions or assessments.\n12. Received brain stimulation therapy (e.g., ECT, mECT, TMS, rTMS, deep brain stimulation, vagus nerve stimulation) within 3 months prior to baseline.\n13. Participation in another clinical trial within 1 month prior to baseline (excluding screening failures).\n14. Any other condition deemed by the investigator as unsuitable for participation in the study.","18 Years","65 Years",{"count":79,"type":21},120,[24],"This study investigates whether combining virtual reality mindfulness-based cognitive therapy (VR-MBCT) with transcranial direct current stimulation (tDCS) can effectively treat depression occurring after a stroke (post-stroke depression, PSD). The goal is to determine if this combined approach is more beneficial than either treatment alone or standard care in alleviating depressive symptoms.\n\nThe study will enroll adults aged 18-65 who have experienced a stroke within the past week, are medically stable, and exhibit moderate to severe depression symptoms. Participants must be right-handed and able to undergo MRI scans and study assessments. Individuals with certain neurological or psychiatric conditions, other major health issues, or specific contraindications for tDCS will not be eligible.\n\nProcedures:\n\nThis is a randomized controlled trial lasting approximately 28 weeks, divided into two phases. In the first phase (8 weeks), participants are randomly assigned to one of four groups:\n\nGroup 1: Receives sham (placebo) versions of both VR-MBCT and tDCS plus standard medication.\n\nGroup 2: Receives active tDCS and sham VR-MBCT plus standard medication. Group 3: Receives active VR-MBCT and sham tDCS plus standard medication. Group 4: Receives both active VR-MBCT and active tDCS plus standard medication. Treatments are administered 5-6 times per week for 4 weeks, followed by a 4-week blinded follow-up.The primary outcome is the change in depression scores (HDRS-24、PHQ-9) from baseline to 8 weeks. Secondary outcomes include rates of clinical response, remission, relapse, treatment acceptability, and changes in anxiety, sleep quality, and daily functioning.",[27],[84,85,86],"Post-stroke depression","Transcranial direct current stimulation","Virtual reality mindfulness-based cognitive therapy","NOT_YET_RECRUITING","2026-02-13",{"date":90,"type":33},"2026-02-20",{"date":92,"type":21},"2026-02-10",{"date":94,"type":21},"2027-12-31",{"name":96,"class":40},"Second Affiliated Hospital, School of Medicine, Zhejiang University",{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":105,"phases":4,"briefSummary":106,"conditions":107,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":41},"100615566","construction-and-clinical-validation-study-of-a-prediction-model-for-depression-after-ischemic-stroke-100615566","NCT07294274","Construction and Clinical Validation Study of a Prediction Model for Depression After Ischemic Stroke","Inclusion Criteria:\n\n* Patients with acute ischemic stroke;\n* Admission within 7 days of symptom onset;\n* The patient and\u002For the family members sign a written informed consent form.\n\nExclusion Criteria:\n\n* Confusion of consciousness,severe cognitive impairment, etc\n* Individuals with a history of depression, schizophrenia, bipolar disorder, etc;\n* Individuals unable to participate in neuropsychological examinations due to hearing im pairments, lack of coordination, or neurological deficits, including se vere aphasia.",{"count":104,"type":21},488,"OBSERVATIONAL","Post-stroke depression (PSD) is the most common neuropsychiatric disorder after a stroke, with an incidence rate of 20% to 60%. PSD is not only associated with higher mortality rates, poorer recovery, more obvious cognitive impairments, greater economic burdens, and lower quality of life, but also brings additional medical expenses and care pressure to families. Society also needs to bear higher medical costs. Currently, the early diagnosis of PSD is difficult, which may lead to poor prognosis after stroke. This study aims to utilize machine learning technology to integrate multi-dimensional indicators of patients with ischemic stroke, establish a risk prediction model for PSD, and assist in early, accurate, and individualized assessment of PSD risk in clinical practice.",[27],"2026-02-03",{"date":110,"type":33},"2026-02-05",{"date":112,"type":33},"2025-11-01",{"date":114,"type":21},"2026-07-20",{"name":116,"class":40},"Min Su",{"id":118,"slug":119,"hasResults":11,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":4,"eligibilityCriteria":123,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":22,"phases":127,"briefSummary":128,"conditions":129,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":139,"leadSponsor":141,"locationsCount":4},"100608621","effects-of-robotic-rehabilitation-on-quality-of-life-mood-and-fatigue-after-stroke-100608621","NCT07203937","Effects of Robotic Rehabilitation on Quality of Life, Mood, and Fatigue After Stroke","Effects of Combined Robotic and Conventional Lower Limb Rehabilitation on Quality of Life, Depression, Anxiety, and Fatigue After Stroke: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Age between 18 and 75 years\n* History of ischemic or hemorrhagic stroke at least 3 months prior to enrollment\n* Mini Mental State Examination (MMSE) score of 24 or higher\n* Modified Ashworth Scale score \\\u003C 2 in the lower extremities\n\nExclusion Criteria:\n\n* Severe cognitive or communication impairment\n* Mobility limitations due to joint contracture or deformity\n* Presence of open wounds or pressure ulcers\n* Uncontrolled hypertension or orthostatic hypotension\n* Severe cardiovascular disease, heart failure, cancer, or significant pulmonary disease\n* High fracture risk due to severe osteoporosis\n* Ambulation difficulty caused by lower extremity musculoskeletal disorders\n* Severe psychosis or neurosis\n* Modified Ashworth Scale score \\> 3 in the lower extremities","75 Years",{"count":126,"type":21},36,[24],"Stroke is a major cause of long-term disability and is often associated with reduced quality of life, depression, anxiety, and fatigue. Rehabilitation plays a key role in recovery, and robotic-assisted gait training provides intensive, repetitive, and individualized therapy. However, its effects on psychological outcomes and quality of life are not fully established.\n\nThis randomized controlled trial will compare conventional rehabilitation combined with robotic-assisted gait training to conventional rehabilitation combined with treadmill training in stroke survivors. Both groups will receive treatment 5 days per week for 6 weeks.\n\nAssessments will be conducted at baseline, after 6 weeks of treatment, and at 3 months after treatment. The primary outcome is quality of life. Secondary outcomes include depression, anxiety, and fatigue. The results of this study will provide new evidence on the benefits of robotic rehabilitation for improving both physical and psychological well-being after stroke.",[130,27,131,132,133],"Stroke","Post-stroke Anxiety","Post-stroke Fatigue","Quality of Life","2026-01-23",{"date":136,"type":33},"2026-01-26",{"date":138,"type":21},"2026-01-15",{"date":140,"type":21},"2026-07",{"name":142,"class":40},"Meltem Gunes Akinci",{"id":144,"slug":145,"hasResults":11,"nctId":146,"briefTitle":147,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":11,"sex":17,"minAge":150,"maxAge":77,"enrollmentInfo":151,"targetDuration":4,"studyType":22,"phases":153,"briefSummary":155,"conditions":156,"keywords":157,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":41},"100574459","phase-2-allopregnanolone-zuranolone-in-post-stroke-depression-100574459","NCT06759558","Allopregnanolone (Zuranolone) in Post-stroke Depression","ALLO in PSD","Inclusion Criteria:\n\n* 21-65 years old of any sex and race\u002Fethnicity\n* Clinical ischemic or hemorrhagic acute stroke (confirmed by CT or MRI) occurring within 1 year of date of enrollment\n* Moderate to severe PSD (Post-Stroke Depression) defined as having depressive symptoms lasting for at least 2 weeks and scoring 17 or more on the HAM-D (Hamilton Depression Rating Scale)\n\nExclusion Criteria:\n\n* Have abused or been dependent on narcotics, recreational drug use, or alcohol\n* Advanced liver or kidney problems\n* Pregnant or plan to become pregnant\n* Post-partum period or breastfeeding\n* History of attempted suicide\n* Active psychosis or suicidal ideation necessitating clinical intervention\n* Antidepressant medications titration or initiation within 12 weeks of recruitment\n* History of Bipolar disorder, schizophrenia or treatment resistant depression preceding the stroke","21 Years",{"count":152,"type":21},6,[154],"PHASE2","The goal of this Phase II clinical trial is to learn if the oral synthetic allopreganolone analog (zuranolone) is safe to take and is well tolerated by stroke survivors experiencing moderate to severe post-stroke depression and if it will help with the symptoms of depression. The main questions it will aim to answer are:\n\n* Is zuranolone safe to take by participants who have moderate to severe post-stroke depression?\n* Is zuranolone well-tolerated by participants who have moderate to severe post-stroke depression?\n* Does zuranolone treat moderate to severe post-stroke depression?\n\nThe study will enroll six participants. All participants will be given 50 mg of zuranolone for 14 days.\n\nParticipants will be asked to provide blood samples, complete some questionnaires including those related to mood and a cognitive assessment.",[56],[158,159,160,161],"zuranolone","post stroke depression","allopregnanolone","stroke","2026-01-16",{"date":164,"type":33},"2026-01-20",{"date":166,"type":33},"2026-01-14",{"date":168,"type":21},"2026-06-30",{"name":170,"class":40},"Duke University",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":177,"sex":17,"minAge":76,"maxAge":124,"enrollmentInfo":178,"targetDuration":4,"studyType":22,"phases":180,"briefSummary":181,"conditions":182,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":184,"startDateStruct":186,"completionDateStruct":188,"leadSponsor":189,"locationsCount":4},"100618843","a-study-on-the-application-of-positive-psychological-counseling-based-on-dou-bao-software-in-patients-with-post-stroke-depression-100618843","NCT07336888","A Study on the Application of Positive Psychological Counseling Based on \"Dou Bao\" Software in Patients With Post-stroke Depression","Inclusion Criteria:\n\n* Meets the criteria of either the \"Chinese Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke\" or the \"Chinese Guidelines for the Diagnosis and Treatment of Acute Cerebral Hemorrhage\" and is confirmed by CT or MRI;\n* Patients with stable vital signs and conditions;\n* Meets the \"Third Edition of the Classification and Diagnosis Criteria for Mental Disorders in China\" and has a score of ≥5 on the 9-item Patient Health Questionnaire (PHQ-9) scale;\n* Patients are over 18 years old;\n* Can understand the relevant content of the scale correctly and provide answers independently or with the help of others, have clear consciousness and sign the consent form;\n* Can use smartphones.\n\nExclusion Criteria:\n\n* Those with severe functional impairments of important organs such as the heart, lungs, liver and kidneys;\n* Those without a smart phone;",true,{"count":179,"type":21},240,[24],"Patients with PSD have the characteristics of high incidence rate, difficult identification and great harm. However, the existing AI chat platforms have not developed any relevant software or programs for PSD patients. Given that the chatbot function in the \"Douba\" software is relatively mature and can flexibly modify the corresponding intelligent agent according to user needs, this study intends to appropriately supplement and optimize the AI agent in the \"Douba\" software to explore the effect of the chatbot in the software in alleviating the symptoms of PSD patients.",[130,56],"2026-01-07",{"date":185,"type":33},"2026-01-13",{"date":187,"type":21},"2027-01-01",{"date":94,"type":21},{"name":190,"class":40},"The Fourth Affiliated Hospital of Zhejiang University School of Medicine",{"id":192,"slug":193,"hasResults":11,"nctId":194,"briefTitle":195,"officialTitle":196,"acronym":4,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":206,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":183,"lastUpdatePostDateStruct":212,"startDateStruct":213,"completionDateStruct":215,"leadSponsor":217,"locationsCount":4},"100619335","nursing-health-education-to-improve-functionality-and-quality-of-life-after-ischemic-stroke-100619335","NCT07343284","Nursing Health Education to Improve Functionality and Quality of Life After Ischemic Stroke","Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients With Ischemic Stroke: A Quasi-Experimental, Longitudinal, and Prospective Clinical Trial","Inclusion Criteria:\n\n* Anterior or posterior cerebral occlusion\n\nExclusion Criteria:\n\n* Intracranial hemorrhage\n* Pregnancy\n* Cognitive incapacity for participation\n* Refusal to participate in the study and administer the questionnaires.",{"count":199,"type":21},70,[24],"This study is titled \"Effect of a Nursing Intervention Based on Health Education on Functionality, Depression Symptoms, and Quality of Life in Patients with Ischemic Stroke.\" It is a quasi-experimental, longitudinal, prospective clinical trial that will beconducted with patients who have suffered an ischemic stroke and were treated in the neurology unit of the Lucus Augusti University Hospital, the same center where this study will take place.\n\nThe primary objective of the study is to determine the effect of a nursing intervention based on health education on quality of life and depression symptoms in individuals who have experienced an ischemic stroke.\n\nTo achieve this objective, variables such as cognitive status, depression symptoms, autonomy and ability to perform basic activities of daily living, neurological deficits, and quality of life will be assessed.\n\nRegarding the total number of subjects to be studied, according to the Stroke Atlas in Galicia published by the Spanish Society of Neurology in 2018, the autonomous community of Galicia had a population of 2,701,819 inhabitants. Applying an incidence rate of 187.4 cases per 100,000 inhabitants according to the IBERICTUS study, an estimated 5,064 new stroke cases occur each year in Galicia. The province of Lugo had 324,842 inhabitants as of January 1, 2024, according to the INE; therefore, applying the same incidence rate, an estimated 609 new stroke cases occur per year. Considering the proportion of ischemic strokes compared to other types of strokes (80:20), the estimated number of ischemic stroke cases in Lugo would be 487. The representative sample size of stroke patients in the province of Lugo would be 70 patients, with 35 patients receiving the intervention and 35 serving as controls.\n\nIndependent Variables:\n\nSociodemographic: sex, age, event date. Clinical: stroke type, treatment modality (rt-PA or thrombectomy), falls, pain, pressure ulcers, aspiration, pneumonia, dysphagia, vital signs.\n\nHealth education: received vs. not received.\n\nDependent Variables:\n\nCognitive status (MMSE). Depression symptoms (BDI). Autonomy and ADL performance (Barthel Index). Neurological deficits (NIHSS). Quality of life (European Quality of Life Scale).\n\nInstruments Mini-Mental State Examination (MMSE) Beck Depression Inventory (BDI) Barthel Index NIH Stroke Scale (NIHSS) Visual Analogue Scale (VAS) European Quality of Life Scale (EQLS)",[203,27,204,133,205],"Ischemia Stroke","Post-stroke","Health Education",[207,208,209,210,211],"Ischemic stroke","Nursing","Depression","Health education","Quality of life",{"date":138,"type":33},{"date":214,"type":21},"2026-06-01",{"date":216,"type":21},"2027-12-01",{"name":218,"class":40},"University of Santiago de Compostela",{"id":220,"slug":221,"hasResults":11,"nctId":222,"briefTitle":223,"officialTitle":224,"acronym":4,"eligibilityCriteria":225,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":226,"enrollmentInfo":227,"targetDuration":4,"studyType":22,"phases":229,"briefSummary":230,"conditions":231,"keywords":232,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":235,"lastUpdatePostDateStruct":236,"startDateStruct":238,"completionDateStruct":240,"leadSponsor":242,"locationsCount":41},"100595965","physical-capacity-building-for-chronic-stroke-100595965","NCT07039305","Physical Capacity Building for Chronic Stroke","Modified Cardiac Rehabilitation to Enhance Post-Stroke Physical and Psychosocial Function: Does Depression Limit the Response?","Inclusion Criteria:\n\n* Age 18-80\n* A diagnosis of stroke at least 6 months prior\n* Residual paresis in the lower extremity (Fugl-Meyer lower extremity \\[LE\\] motor score \\\u003C34)\n* Ability to walk without assistance and without an AFO during testing and training at speeds ranging from 0.2-1.0 m\u002Fs\n* Ability to follow instructions, complete cognitive testing and to communicate exertion, pain and distress\n* No antidepressant medications or no change in doses of psychotropic medication for at least 4 weeks prior to the study (6 weeks if newly initiated medication)\n* HDRS17 question #3 and PHQ-9 question #9 regarding suicide ≤ 2\n* Provision of informed consent.\n\nIn addition, depressed subjects will screen for probable major depressive disorder (Patient Health Questionnaire-9 ≥ 10) and be diagnosed using the Structured Clinical Interview for Depression (SCID) according to the DSM-5.\n\nExclusion Criteria:\n\n* Unable to ambulate at least 150 feet or experienced intermittent claudication while walking\n* Unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during ADL's\n* Dementia\n* Life expectancy \\\u003C1 yr\n* History of DVT or pulmonary embolism within 6 months\n* Uncontrolled diabetes with recent weight loss, diabetic coma, or frequent insulin reactions\n* Severe hypertension with systolic \\>200 mmHg and diastolic \\>110 mmHg at rest\n* Attempt of suicide in the last 2 years or suicidal risk assessed by depression screening\n* Current enrollment in a rehabilitation trial to enhance motor, cognitive and or psychosocial recovery\n* Severe cognitive impairment (MoCA score ≤15)\n* Moderate to severe neglect that precludes cognitive testing\n\nFor brain stimulation procedures only:\n\n* Electronic or metallic implants\n* History of seizures\n* Women of child bearing potential","80 Years",{"count":228,"type":21},76,[24],"Cardiac rehabilitation is the standard-of-care treatment option for patients with cardiovascular disease and has been shown to improve many aspects critical to patient recovery. Investigators believe that individuals who have had a stroke need to be treated similarly. Investigators will study the effects of a comprehensive modified cardiac rehabilitation program to determine if it can improve some of the physical and psychosocial problems common in survivors of stroke with and without depression.",[130,27],[209,233,130,234],"Exercise","Stroke Recovery","2025-12-01",{"date":237,"type":33},"2025-12-08",{"date":239,"type":33},"2025-08-05",{"date":241,"type":21},"2029-08",{"name":243,"class":40},"Medical University of South Carolina",{"id":245,"slug":246,"hasResults":11,"nctId":247,"briefTitle":248,"officialTitle":249,"acronym":4,"eligibilityCriteria":250,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":22,"phases":253,"briefSummary":254,"conditions":255,"keywords":258,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":262,"lastUpdatePostDateStruct":263,"startDateStruct":265,"completionDateStruct":266,"leadSponsor":268,"locationsCount":41},"100586978","the-effects-of-naturalistic-light-on-post-stroke-complications-related-brain-areas-in-stroke-patients-during-admission-for-rehabilitation-100586978","NCT06922409","The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation.","The Effects of Naturalistic Light on Post Stroke Complications Related Brain Areas in Stroke Patients During Admission for Rehabilitation","Inclusion Criteria:\n\n* Patients scoring moderate-severe fatigue and\u002For depression OR NO fatigue and\u002For depressione which are evaluated as candidates for the rehabilitation unit.\n\nExclusion Criteria:\n\n* GCS \\\u003C 15\n* No functioning nervus opticus or retina in both eyes\n* Unable to open both eyes\n* Non communicating patients e.g. severe aphasia (incompetent patients)\n* Unable to cooperate to the physical examinations\n* Less than 10 days of hospitalization in the rehabilitation department\n* Claustrophobia\n* If the sub investigator finds the study participant unfit to conduct the investigations",{"count":252,"type":21},45,[24],"Background:\n\nLight is the most important regulator of circadian rhythm. Naturalistic light, which contains the spectrum of sunlight throughout the day, has been shown to have a positive impact on mental states such as depression and fatigue in stroke and other diseases requiring long-term hospitalization.\n\nDepression and fatigue are very common complications after stroke, with a frequency of 30% and 85%, respectively. Both are significantly related to reduced quality of life and early death. Both the causes and pathophysiology behind these complications are unknown, but it is assumed that disturbances (inflammation and cell death) in brain areas and brain networks related to arousal, sleep, circadian rhythm, and the frontal lobe play a role.\n\nThe hypothesis is that it is possible to detect changes in brain networks related to depression and fatigue by MRI, and that naturalistic light will affect these changes.\n\nMethod:\n\nStroke patients requiring a minimum of 10 days of rehabilitation are transferred to a neurorehabilitation unit with naturalistic lighting.\n\nExamination:\n\nValidated tests for fatigue, depression, sleep and cognitive functions.\n\nPathophysiological studies:\n\n* MRI focusing on cerebral blood flow, metabolism, and cerebral networks.\n* Spinal fluid analyses for hormones and markers involved in immunological response as well as wakefulness\u002Farousal and depression.\n* Sleep assessments.",[56,256,257,130],"Post Stroke Fatigue","Circadian Dysregulation",[259,130,56,256,260,261],"circadian rhythm disruption","Light therapy","Circadian Light","2025-04-10",{"date":264,"type":33},"2025-04-15",{"date":262,"type":33},{"date":267,"type":21},"2030-01-01",{"name":269,"class":40},"Rigshospitalet, Denmark",{"id":271,"slug":272,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":4,"eligibilityCriteria":276,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":277,"targetDuration":4,"studyType":22,"phases":278,"briefSummary":279,"conditions":280,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":282,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":285,"leadSponsor":287,"locationsCount":289},"100586847","efficacy-of-remote-ischemic-conditioning-in-preventing-post-stroke-depression-100586847","NCT06920706","Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression","Efficacy of Remote Ischemic Conditioning in Preventing Post-Stroke Depression: A Multicenter, Randomized, Double-Blind, Sham-Controlled Clinical Trial","Inclusion Criteria:\n\n* Patient age≥18 years;\n* No gender preference;\n* Diagnosed with acute ischemic stroke;\n* From onset to treatment ≤48 h;\n* 6≤ NIHSS scores ≤25;\n* Premorbid mRS ≤1;\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Baseline HAMD-24 scores ≥8;\n* Infarction area overlapped with the area where the DTI-ALPS index is calculated;\n* A history of severe mental illness such as depression, bipolar disorder, and schizophrenia;\n* A history of mental disorders caused by other organic diseases, such as post-Parkinson depression;\n* Participants with cognitive impairment, disturbance of consciousness, severe hearing impairment, or aphasia who were unable to cooperate with the assessment;\n* A history of autoimmune diseases (such as multiple sclerosis, neuromyelitis optica spectrum disorders, systemic lupus erythematosus, etc.), malignant tumors, or obstructive sleep apnea hypopnea syndrome;\n* Intracranial tumor, arteriovenous malformation, or aneurysm;\n* Uncontrolled severe hypertension (systolic pressure \\>180mmHg or diastolic pressure \\>110 mmHg after drug treatment) ;\n* Subclavian artery stenosis≥50% or subclavian steal syndrome;\n* Any contraindication for remote ischemic adaptation: the upper limb has serious soft tissue injury, fracture or vascular injury, distal upper limb perivascular lesions, etc.;\n* Severe coagulation dysfunction, platelet count \\\u003C 100×10\\^9\u002FL, cardiac dysfunction (NYHA class Ⅲ or above), hepatic dysfunction (aspartate aminotransferase and\u002For alanine aminotransferase \\> 3 times the upper limit of normal), or renal dysfunction (serum creatinine \\> 265μmol\u002FL);\n* Any contraindication for magnetic resonance imaging: metal implants, claustrophobia, etc.;\n* Women known to be pregnant or lactating, or have a positive pregnancy test;\n* Participating in other clinical trials within three months;\n* Participants not suitable for this clinical studies considered by researcher.",{"count":179,"type":21},[24],"Post-stroke depression (PSD) is characterized primarily by low mood and loss of interest following a stroke. It is one of the most common and serious complications of stroke, with an incidence of 11% to 41% within two years post-stroke. PSD significantly impacts stroke prognosis, not only hindering neurological recovery but also increasing clinical disability and mortality rates, thereby imposing substantial economic and psychological burdens on families and society. Therefore, preventing PSD is crucial for stroke rehabilitation.\n\nClinical trials have demonstrated that preventive antidepressant treatment can reduce PSD incidence and improve clinical outcomes; however, controversies remain regarding the timing, methods, and safety. Meanwhile, preventive psychological therapy faces challenges in implementation due to effectiveness, accessibility, and cost-effectiveness.\n\nRemote ischemic preconditioning (RIC) is a non-invasive, cost-effective, and non-pharmacological intervention. By modulating small molecules in the peripheral and central nervous systems through transient, periodic limb blood flow restriction and reperfusion, RIC reverses neurobiological changes and demonstrates neuroprotective potential in various neurological diseases. Recently, a study showed that RIC is safe and effective in preventing PSD; however, the sample size is small and the specific mechanisms remain unclear. Therefore, this study aims to further explore the role and mechanisms of RIC in PSD prevention.",[27,281],"Remote Ischemic Conditioning","2025-04-02",{"date":262,"type":33},{"date":262,"type":21},{"date":286,"type":21},"2026-12-31",{"name":288,"class":40},"Xuanwu Hospital, Beijing",5,{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":177,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":298,"briefSummary":299,"conditions":300,"keywords":301,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":304,"lastUpdatePostDateStruct":305,"startDateStruct":307,"completionDateStruct":309,"leadSponsor":311,"locationsCount":4},"100586193","investigating-how-the-rect-impacts-brain-functional-states-through-the-acc-cerebellar-loop-100586193","NCT06912191","Investigating How the RECT Impacts Brain Functional States Through the ACC-cerebellar Loop","Inclusion Criteria:\n\n* Onset of stroke \\\u003C6 months ago, or \\>6 months since the last stroke event;\n* Age \\>=18 years and \\\u003C85 years (as the probability of Vascular Cognitive Impairment increases above 85);\n* Patients with damage in the middle cerebral artery territory;\n* NIHSS \\>4 and \\\u003C26;\n* mRS score \\>=2;\n* Completion of CT or MRI;\n* No neurological or psychiatric disorders; no impairment of consciousness; able to comply with relevant treatments; no severe cognitive dysfunction (MMSE \\>=15);\n* All participants are right-handed; Sign the informed consent form.\n\nExclusion Criteria:\n\n* History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);\n* Severe comorbidities;\n* History of medication use: benzodiazepines, baclofen, antidepressants;\n* Non-compliance with the treatment plan;\n* Acute-phase cerebral hemorrhage, acute infectious diseases;\n* Severe suicidal tendencies in individuals with depression;\n* Individuals suffering from severe headaches, high blood pressure, malignant tumors, open wounds, vascular embolism, leukopenia, etc.;\n* Severe alcohol abuse;\n* History of cranial surgery, individuals with metal implants in the brain;\n* Individuals with an implanted cardiac pacemaker;\n* NIHSS \\>26, MMSE \\\u003C15;\n* Any disease likely to prevent the patient from surviving more than one month;\n* Pregnant individuals.",{"count":297,"type":21},100,[24],"Experiment1: Using a brain EEG-TMS combined system, researchers aim to investigate the impact of the rostral anterior cingulate cortexr (rACC)-engaging cognitive task (RECT) combined single-pulse TMS magnetic stimulation on theta neural oscillations in the medial frontal lobe. The study will be divided into 4 groups: the first group will receive left cerebellar single-pulse TMS stimulation combined with the RECT task, the second group will receive right cerebellar single-pulse TMS stimulation combined with the RECT task, the third group will receive midline cerebellar single-pulse TMS stimulation combined with the RECT task, and the fourth group will receive sham cerebellar single-pulse TMS stimulation combined with the RECT task. Divide the participants into groups of 15 people each, following a 1:1:1:1 ratio. Based on the above testing, the stimulus method that results in the most significant change in the midline of the frontal lobe will be identified.\n\nExperiment 2: Based on the research from Experiment 1, the most significant approach affecting theta neural oscillations in the medial frontal gyrus will be identified. This stimulation protocol will be combined with left dorsolateral prefrontal cortex iTBS stimulation in Experiment 2. The research aim of Experiment 2 is to investigate the most effective stimulation method for enhancing midline theta neural oscillations in the frontal lobe, in combination with left dorsolateral prefrontal cortex iTBS, for the treatment of post-stroke depression patients. This study will include 40 post-stroke depressed patients, and each participant must meet the inclusion criteria. The first group of participants, consisting of 20 individuals, will receive the optimal combination intervention. The second group of participants will only receive iTBS stimulation, without any additional intervention strategies used in Experiment 1. Patients will undergo Hamilton Depression Scale assessment and resting state and task state EEG collection at baseline, one week after intervention, and two weeks after intervention.The primary outcome will be the Hamilton Depression Scale, with EEG-related data being analyzed as a secondary outcome. Task-oriented EEG detection will include both facial expression recognition paradigm and oddball experiment paradigm. Reaction time, accuracy, and completion status will be recorded simultaneously in the experiment. The experiment will record patients' tolerance and any adverse events that occur.",[27],[302,303],"EEG","ERP","2025-03-29",{"date":306,"type":33},"2025-04-04",{"date":308,"type":21},"2025-03-30",{"date":310,"type":21},"2027-05-30",{"name":312,"class":40},"The Second Affiliated Hospital of Kunming Medical University",{"id":314,"slug":315,"hasResults":11,"nctId":316,"briefTitle":317,"officialTitle":318,"acronym":4,"eligibilityCriteria":319,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":320,"targetDuration":4,"studyType":22,"phases":322,"briefSummary":323,"conditions":324,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":325,"lastUpdatePostDateStruct":326,"startDateStruct":328,"completionDateStruct":330,"leadSponsor":332,"locationsCount":4},"100585248","the-research-team-aims-to-elucidate-the-impact-of-itbs-intermittent-theta-burst-stimulation-on-the-hpa-axis-and-post-stroke-negative-emotionsdepression-by-conducting-human-experiments-that-target-various-brain-regions-100585248","NCT06899893","The Research Team Aims to Elucidate the Impact of ITBS (intermittent Theta Burst Stimulation) on the HPA Axis and Post-stroke Negative Emotions\u002Fdepression by Conducting Human Experiments That Target Various Brain Regions.","Investigating the Impact of ITBS Stimulation on Various Brain Regions on the HPA Axis in Stroke Patients Using Resting-State EEG Data.","Inclusion Criteria:\n\n1. Initial stroke onset \\\u003C6 months, or the last stroke event occurred more than 6 months ago;\n2. Age ≥18 years, \\\u003C85 years (the likelihood of VCI increases beyond 85 years);\n3. Patients with lesions in the middle cerebral artery region;\n4. NIHSS \\>4, NIHSS \\\u003C26;\n5. mRS score ≥2;\n6. Completion of CT or MRI;\n7. No severe neurological or psychiatric disorders; no impairment of consciousness, able to cooperate with relevant treatments; no severe cognitive impairment (MMSE ≥15);\n8. All participants are right-handed;\n9. Signed informed consent form.\n\nExclusion Criteria:\n\n1. History of epilepsy or psychiatric disorders (including depression, anxiety, or schizophrenia);\n2. Severe comorbidities;\n3. History of medication use: benzodiazepines, baclofen, or antidepressants;\n4. Non-compliance with the protocol;\n5. Acute phase of cerebral hemorrhage or acute infectious diseases;\n6. Severe suicidal tendencies in patients with depression;\n7. Severe headache, hypertension, malignant tumors, open wounds, vascular embolism, leukopenia, or other serious conditions;\n8. Severe alcohol abuse;\n9. History of cranial surgery or presence of metal implants in the brain;\n10. Patients with cardiac pacemakers;\n11. NIHSS \\> 26 or MMSE \\\u003C 15;\n12. Any condition likely to result in the patient's survival for less than 1 month;\n13. Pregnancy.",{"count":321,"type":21},60,[24],"The project team will categorize stroke patients into three groups receiving iTBS stimulation targeting distinct brain regions: the cerebellum, the dorsolateral prefrontal cortex (DLPFC), and the primary motor cortex (M1), with 20 patients allocated to each group. Neurofunctional scores, anxiety and depression assessments, and transcranial magnetic stimulation evoked potentials (TEP) will be assessed pre- and post-treatment within each group. The relationship between anxiety and depression scores and brain network characteristics associated with emotions will be examined to investigate the impact of iTBS stimulation on post-stroke negative emotions. Furthermore, plasma and saliva samples will be collected from stroke patients in each group post iTBS intervention. ELISA will quantify ACTH levels in plasma and cortisol levels in both plasma and saliva, with the aim of exploring the effects of iTBS stimulation on the HPA axis across different brain regions.",[130,27],"2025-03-21",{"date":327,"type":33},"2025-03-28",{"date":329,"type":21},"2025-04-01",{"date":331,"type":21},"2027-07-30",{"name":312,"class":40},{"id":334,"slug":335,"hasResults":11,"nctId":336,"briefTitle":337,"officialTitle":337,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":177,"sex":17,"minAge":76,"maxAge":50,"enrollmentInfo":338,"targetDuration":4,"studyType":22,"phases":340,"briefSummary":341,"conditions":342,"keywords":4,"overallStatus":87,"whyStopped":4,"lastUpdateSubmitDate":343,"lastUpdatePostDateStruct":344,"startDateStruct":346,"completionDateStruct":348,"leadSponsor":350,"locationsCount":4},"100582218","to-explore-the-neural-processing-mechanism-of-cerebellum-involved-in-facial-expression-recognition-based-on-transcranial-magnetic-stimulation-100582218","NCT06860451","To Explore the Neural Processing Mechanism of Cerebellum Involved in Facial Expression Recognition Based on Transcranial Magnetic Stimulation",{"count":339,"type":21},160,[24],"Experiment 1: Utilizing a transcranial magnetic stimulation-electroencephalography\u002Ffunctional near-infrared spectroscopy system, the investigators aim to determine whether transcranial magnetic stimulation of the cerebellum can alter neural oscillations and blood flow changes in the prefrontal cortex. The investigators will recruit 80 healthy volunteers and 80 stroke patients with middle cerebral artery infarction, each meeting the inclusion criteria. Twenty healthy volunteers and twenty patients will be randomly selected to receive a single-pulse transcranial magnetic stimulation (TMS) to the cerebellar vermis. The investigators will record cerebellar transcranial evoked potentials (TEP) in the EEG to assess cerebellar cortical excitability and inhibition and evaluate individuals using functional near-infrared spectroscopy to analyze changes in prefrontal blood flow and brain networks. The other 40 healthy volunteers and 40 patients will receive a single-pulse TMS to the right or left cerebellum, and similar assessments will be made. The remaining 20 healthy volunteers and 20 patients will receive a sham iTBS, with similar assessments.\n\nExperiment 2: Through a facial expression recognition task, this experiment aims to clarify the cerebellum's increased perception of negative emotions, thereby achieving a rebalance from \"controlled\" to \"automatic\" regulation of negative emotions, ultimately playing a role in \"automatic\" emotional adjustment. The 80 healthy volunteers from Experiment 1 will be equally divided into four groups based on stimulation site: the cerebellar vermis; the right cerebellum; the left cerebellum; the sham stimulation. Each group will perform the facial expression recognition task during the TMS stimulation. The investigators will collect functional near-infrared spectroscopy and task-based EEG data from the participants during stimulation while also recording their response times, accuracy rates, and completion conditions, including their tolerance of the experiment and any adverse events.",[27],"2025-03-03",{"date":345,"type":33},"2025-03-06",{"date":347,"type":21},"2025-03-25",{"date":349,"type":21},"2025-12-30",{"name":312,"class":40},{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":4,"eligibilityCriteria":357,"healthyVolunteers":11,"sex":17,"minAge":76,"maxAge":4,"enrollmentInfo":358,"targetDuration":4,"studyType":22,"phases":359,"briefSummary":360,"conditions":361,"keywords":363,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":365,"lastUpdatePostDateStruct":366,"startDateStruct":368,"completionDateStruct":370,"leadSponsor":372,"locationsCount":41},"100557634","efficacy-and-safety-of-auricular-acupuncture-in-treating-insomnia-post-stroke-100557634","NCT06540664","Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke","Evaluating Efficacy and Safety of Auricular Acupuncture in Treating Insomnia Post-stroke: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients aged 18 years or older, with a post-stroke period of 03 months or more, based on discharge papers or medical records.\n* Patients who meet the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association for at least 3 months.\n\nExclusion Criteria:\n\n* Patients with insomnia before the stroke.\n* Patients diagnosed with other sleep disorders such as sleep apnea syndrome, narcolepsy.\n* Patients diagnosed with neurological diseases or psychiatric disorders such as: Anxiety disorders, autism spectrum disorders, depression, obsessive-compulsive disorder, behavioral disorders affecting sleep before the stroke.\n* Patients are using antidepressants, psychiatric drugs.\n* Patients participating in other clinical trials with behavioral, psychological or complementary medical interventions during the study period.\n* Patients not cooperating during data collection",{"count":321,"type":21},[24],"The goal of this clinical trial is to learn if Auricular acupuncture works to treat Insomnia Post-stroke patients. It will also learn about the safety of Auricular. The main questions it aims to answer are:\n\n* Does Auricular acupuncture reduce the time it took participants to fall asleep?\n* Dose Auricular acupuncture increase the number of hours participants slept?\n* Dose Auricular acupuncture improve sleep quality as measured by The Pittsburgh Sleep Quality Index (PSQI)?\n* What medical problems do participants have when taking Auricular acupuncture? Researchers will compare Auricular acupuncture to a sham Auricular acupuncture (a look-alike acupuncture needles that contains no needles) to see if Auricular acupuncture works to treat insomnia post-stroke.\n\nParticipants will:\n\n* Take Auricular acupuncture or sham Auricular acupuncture every 5 days for 4 weeks.\n* Checkups and evaluate sleep onset time, sleep hours, and sleep quality every 5 days for 4 weeks.\n* Keep a diary sleep of their symptoms and the number of times they use sleeping pills.",[362,27],"Insomnia, Secondary",[364],"insomnia","2024-09-26",{"date":367,"type":33},"2024-10-01",{"date":369,"type":33},"2024-03-01",{"date":371,"type":21},"2024-10",{"name":373,"class":40},"University of Medicine and Pharmacy at Ho Chi Minh City"]