[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vasospasm-cerebral\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vasospasm-cerebral":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,47,70,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100603067","the-effect-of-transcutaneous-vagal-nerve-stimulation-tvns-on-cerebral-vasospasm-secondary-to-aneurysmal-subarachnoid-hemorrhage-100603067",false,"NCT07131696","The Effect of Transcutaneous Vagal Nerve Stimulation (tVNS) on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage","Inclusion Criteria:\n\n* Provision of signed and dated informed consent\n* Stated willingness to comply with all study procedures and availability for the duration of the study\n* Male or Female\n* 18-65 years of age\n* Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage\n* Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage\n* For females of reproductive potential: negative pregnancy test at time of treatment.\n* Plan to undergo standard of care treatment and follow-up\n\nExclusion Criteria:\n\n* Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)\n* Does not provide consent\n* Posterior circulation aneurysmal subarachnoid hemorrhage\n* Initial aneurysm treatment after post bleed day 1","ALL","18 Years","65 Years",{"count":19,"type":20},10,"ESTIMATED","INTERVENTIONAL",[23],"NA","The significance of developing a safe and effective therapy for aneurysmal subarachnoid hemorrhage (aSAH) patients suffering cerebral vasospasm (CVS) cannot be overstated. Vasospasm - a clamping down of normal arteries in the days following rupture - remains incredibly challenging to treat.1,2 Current drugs and minimally invasive surgical therapies are helpful, yet woefully insufficient. Symptomatic cerebral vasospasm afflicts about 30% of aneurysmal subarachnoid hemorrhage patients and nearly half will go on to suffer a stroke, despite aggressive medical care.1-3 The autonomic nervous system is a balance between sympathetic (fight or flight) and parasympathetic (rest and digest) influence with sympathetic overactivity and inflammation shown to play an important role in the development and severity of cerebral vasospasm.4,5,17-20 Prior studies of autonomic nervous system neuromodulation highlight its promise as a promising potential avenue to improve morbidity and mortality from CVS in aSAH.6-15 Despite progress, continued high levels of CVS morbidity and mortality stress the urgent need for exploration of neuromodulation therapy.\n\nIn this proposal, the study team will modulate the autonomic nervous system function in aSAH patients using transcutaneous vagal nerve stimulation (tVNS). tVNS involves placement of a stimulation electrode on the external ear to non-invasively stimulate a branch of the vagal nerve and increase parasympathetic influence. This device has FDA approval for epilepsy and cluster headache.\n\nThe study hypothesis is that neuromodulation of the autonomic nervous system with tVNS (increasing parasympathetic influence) reduces sympathetic overactivity and inflammation in aSAH resulting in decreased morbidity of CVS.",[26,27,28,29],"Aneurysmal Subarachnoid Hemorrhage","Vasospasm, Cerebral","Transcutaneous Vagal Nerve Stimulation (tVNS)","Endovascular Treatment",[31,32,33],"CVS","aSAH","tVNS","NOT_YET_RECRUITING","2025-08-12",{"date":37,"type":38},"2025-08-20","ACTUAL",{"date":40,"type":20},"2026-09",{"date":42,"type":20},"2028-09",{"name":44,"class":45},"Marshall Holland","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":53,"targetDuration":4,"studyType":21,"phases":55,"briefSummary":56,"conditions":57,"keywords":58,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":46},"100550138","the-effect-of-sympathetic-modulation-on-cerebral-vasospasm-secondary-to-aneurysmal-subarachnoid-hemorrhage-100550138","NCT06443177","The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid Hemorrhage","Inclusion Criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Diagnosed with Fisher grade 3 or 4 aneurysmal subarachnoid hemorrhage (1)\n4. Ability to undergo endovascular treatment of aneurysmal subarachnoid hemorrhage\n5. For females of reproductive potential: Negative pregnancy test at time of treatment\n6. Plan to undergo standard of care and follow-up\n\nExclusion Criteria:\n\n1. Medically unfit to undergo endovascular treatment (e.g., Hunt Hess grade 5)\n2. Does not provide consent for the procedure.\n3. Posterior circulation aneurysmal subarachnoid hemorrhage.\n4. Initial aneurysm treatment after post bleed day 1",{"count":54,"type":20},25,[23],"The purpose of the study is to see that in addition to existing therapy, how well an additional procedure named spinal cord stimulation might reduce blood vessel spasm from aneurysm rupture.",[27,26],[32,31,59,60],"Sympathetic Modulation","Ruptured brain aneurysm","2025-07-09",{"date":63,"type":38},"2025-07-10",{"date":65,"type":20},"2026-07-31",{"date":67,"type":20},"2027-07-31",{"name":69,"class":45},"University of Alabama at Birmingham",{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":77,"sex":15,"minAge":16,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":4,"briefSummary":82,"conditions":83,"keywords":4,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":46},"100585750","mechanisms-of-brain-heart-injury-of-post-intracranial-hemorrhage-100585750","NCT06906432","Mechanisms of Brain-Heart Injury of Post-Intracranial Hemorrhage","Multimodal Omics and Imaging Study on the Mechanisms of Brain-heart Injury in Patients With Intracranial Hemorrhage","Inclusion Criteria:\n\n1. Patients aged 18 years or older at the time of enrollment.\n2. Acute intracranial hemorrhage confirmed by neuroimaging (CT, MRI，CTA, MRA, or DSA) within 48 hours of symptom onset.\n3. Ability to provide informed consent or have a legally authorized representative willing to consent on their behalf.\n\nExclusion Criteria:\n\n1. Patients who refuse to participate in the study or cannot provide informed consent.\n2. Patients with a history of significant cardiovascular disease, including myocardial infarction, heart failure, or arrhythmias, unless stable and well-controlled.\n3. Patients who have undergone cardiac bypass surgery, stent placement, or other cardiovascular interventions within the past 6 months.\n4. Patients with active brain tumors, ischemic stroke within 3 months or a history of previous brain injury that could confound the study findings.\n5. Patients with active malignant disease, severe inflammatory or infectious disease, or those who have undergone surgery for any reason within the past 3 months.\n6. Patients with any condition that, in the opinion of the investigator, would make it unsafe or impractical to participate in the study.",true,"80 Years",{"count":80,"type":20},1000,"OBSERVATIONAL","Intracranial hemorrhage is a condition characterized by high mortality rates and suboptimal functional outcomes. It precipitates both direct brain injury and subsequent secondary injuries, including delayed cerebral ischemia, brain edema, and hydrocephalus. Complications such as cardiac injury may also arise, categorizing them within the cerebrocardiac syndrome (CCS). The clinical spectrum of CCS encompasses acute myocardial injury, acute coronary syndrome, left ventricular systolic and diastolic dysfunction, cardiac arrhythmias, and sudden cardiac death, all of which are associated with increased mortality and deterioration in patient status. The precise pathophysiological mechanisms underlying both cerebral and cardiac injuries remain enigmatic, and the implications for diagnosis and therapeutic strategies are yet to be fully explored.\n\nIn this study, we propose to enroll patients with intracranial hemorrhage who will undergo conventional treatment and comprehensive multidisciplinary evaluations. Our observational research is grounded in a multimodal omics and imaging approach, aimed at investigating both local and systemic injuries subsequent to intracranial hemorrhage. This comprehensive strategy is intended to facilitate precise diagnosis, risk stratification, and clinical decision-making, while also shedding light on the pathophysiological mechanisms involved.\n\nThe primary objectives of this research are to address the following key questions:\n\n* \\[Question 1\\] What are the pathophysiological mechanisms underlying cardiac injury in patients with intracranial hemorrhage?\n* \\[Question 2\\] What are the pathophysiological mechanisms responsible for early and delayed brain injuries following intracranial hemorrhage?\\"",[84,85,86,87,88,89,90,91,92,93,27,94],"Subarachnoid Hemorrhage, Aneurysmal","Cerebrocardiac Syndrome","Mass Spectrometry","Heart Failure","Atrial Fibrillation","Ischemic Heart Disease","Heart Infarction","Arrhythmias, Cardiac","Delayed Cerebral Ischemia","Hydrocephalus","Intracerebral Hemorrhage","RECRUITING","2025-03-29",{"date":98,"type":38},"2025-04-02",{"date":100,"type":38},"2024-08-01",{"date":102,"type":20},"2036-12-01",{"name":104,"class":45},"Beijing Tiantan Hospital",{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":113,"enrollmentInfo":114,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":120,"overallStatus":95,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":46},"100400125","prevention-of-vasospasm-in-sah-through-csf-treatment-100400125","NCT04490161","Prevention of Vasospasm in SAH Through CSF Treatment","Prevention of Cerebral Vasospasm Following Aneurysmal Subarachnoid Hemorrhage Through Treatment With Intravenous Autologous Cerebrospinal Fluid - a Pilot Trial.","PREVAIL","Inclusion Criteria:\n\nAge: \\>18, \\\u003C90\n\n* SAH HH 3 - 5\n* Cerebral saccular Aneurysm\n* Digital subtraction angiography prior to aneurysm repair\n* Aneurysm repair within 72h\n* Modified Fisher Grade 3+4\n* Presence of aneurysm needing treatment (clipping or coiling)\n* Treatment within 24 hours of symptom onset\n* External ventricular drain (clinical need)\n\nExclusion Criteria:\n\n* Non-aneurysmal SAH\n\n  * SAH HH\\\u003C3\n  * Extensive intraventricular haemorrhage (unable to obtain CSF without massive aspiration of clotted blood)\n  * Contraindication for digital subtraction angiography\n  * Aneurysm repair \\>72h after rupture\n  * Signs of radiographic vasospasm upon diagnosis\n  * Presence of systemic or CSF infection\n  * Contraindication for oral Nimodipin\n  * Pregnancy","90 Years",{"count":115,"type":20},20,[23],"The pathophysiological mechanisms of aneurysmal subarachnoid haemorrhage (aSAH) involve early brain injury (EBI) and delayed cerebral ischemia (DCI).\n\nSeveral mechanisms contribute to EBI pathogenesis, including cell death, inflammatory response, oxidative stress, excitotoxicity, microcirculatory dysfunction, microthrombosis and cortical spreading depolarization. All are suggested to be linked due to common pathogenic pathways and direct interaction.\n\nDespite advances in research of diagnostics and treatment strategies, brain injury remains the major cause of death and disability in SAH patients. There is no sufficient treatment of SAH and its devastating consequences known so far. Developing and improving diagnostic methods to monitor SAH patients and to evaluate efficacy of treatment strategies are essential in SAH research. These include neuroimaging, biomarkers, and other parameters such as invasive multimodal neuromonitoring and intraoperative electrophysiological monitoring.\n\nCerebral vasospasm (CV) - mostly responsible for DCI - can be depicted on angiograms. Altogether, tremendous efforts have been taken to conquer the occurrence and sustainability of CV. The mortality of patients suffering aSAH rises up to 50% if the patients' condition is critical (Hunt\\&Hess (HH) Grade 5, WFNS Grade 5, modified Fisher Grade 4).\n\nReports of beneficial outcome in patients with pre-existing CSF shunting have been published. The hypothesis of early CSF reapplication to the bloodstream, in order to prevent CV seems to be positively approved by the mentioned reports. Nevertheless, no data could be found on the mechanisms of action in this phenomenon.\n\nTo confirm the presence of interaction of the mechanisms of EBI and evaluate the application of cerebrospinal fluid (CSF), a pilot clinical trial was planned. Due to the lack of validated animal models for aSAH it is necessary to perform the trial first-in-human. A pilot (proof of concept) trial - is done through inclusion of 10 patients with severe aSAH (≥HH4). According to clinical guidelines, these patients receive external ventricular drainages in order to drain CSF and lower intracranial pressure. An interim analysis of data will be performed after inclusion and treatment of 5 patients. Blood-\u002FCSF-sampling for further analysis will be collected before, during and after treatment according to the study protocol.",[119,84,27,26],"Subarachnoid Hemorrhage",[121,122,123,124,125,126],"EVD","Aneurysm","SAH","Subarachnoid hemorrhage","cerebral vasospasm","cerebrospinal fluid","2024-11-25",{"date":129,"type":38},"2024-11-27",{"date":131,"type":38},"2020-01-01",{"date":133,"type":20},"2025-02-01",{"name":135,"class":45},"Medical University Innsbruck"]