[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"intracranial-pressure-changes\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:intracranial-pressure-changes":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"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":4,"briefSummary":23,"conditions":24,"keywords":34,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100544420","comind-early-feasibility-study-100544420",false,"NCT06368648","CoMind Early Feasibility Study","An Early Feasibility Study for the Development of a Model to Non-Invasively Estimate Intracranial Pressure (ICP) and New Metrics of Cerebral Autoregulation (CAR) Using the CoMind One EFS Device","CoMind EFS","Inclusion Criteria:\n\n1. Male or female sex at birth, and aged 18 years or older on the date of enrollment.\n2. Receiving continuous invasive ICP monitoring (Bolt or EVD) as part of standard care.\n3. Invasive ICP monitor catheter penetrating the parenchyma or ventricles.\n4. Receiving continuous invasive ABP monitoring as part of standard care.\n\nExclusion Criteria:\n\n1. Presence of any implant (cosmetic or otherwise) in the frontal bone in such proximity to the CoMind One EFS Sensor that they might physically touch.\n2. Open wounds on the forehead such that CoMind One EFS Sensor cannot be safely placed over an area of intact skin\n3. Presenting with radiographic evidence of a non-intact skull at the recording site on admission.\n4. If patient is enrolled in an intervention\u002Fstudy that may interfere with SoC ICP measurements or the CoMind One EFS device measurement then the patient is ineligible.\n5. Patients with decompressive craniectomy will be excluded unless a CoMind One EFS recording can be made from intact skull.","ALL","18 Years",{"count":20,"type":21},581,"ESTIMATED","OBSERVATIONAL","The purpose of this research, which has been determined as non-significant risk by the central IRB overseeing the study, is to obtain information to help further develop a machine (a medical device) to measure the pressure around the brain from the outside (this pressure is called intracranial pressure or ICP). Monitoring and managing ICP is an important part of care for patients with conditions such as Traumatic Brain Injury (TBI). However, the current way of measuring ICP requires surgery to drill a hole into the skull, and therefore can introduce additional risks such as infections and pain.\n\nRecent research has shown it may be possible to measure ICP without needing surgery. This technology is in development, but large amounts of data is required to build these new devices.\n\nThrough collecting a large database of information from patients who have both the routine surgical device and the research device applied to their head, the research team will work to develop and test an effective and potentially safer way of monitoring patient ICP.",[25,26,27,28,29,30,31,32,33],"Intracranial Pressure","Intracranial Pressure Changes","Traumatic Brain Injury","Intracerebral Hemorrhage","Encephalitis","Encephalopathy","Hydrocephalus","Stroke","Autoregulation",[25,27,35],"Cerebral Autoregulation","RECRUITING","2026-02-12",{"date":39,"type":40},"2026-02-13","ACTUAL",{"date":42,"type":40},"2024-11-27",{"date":44,"type":21},"2026-11",{"name":46,"class":47},"CoMind Technologies Limited","INDUSTRY",14,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100610072","non-invasive-intracranial-pressure-estimation-by-measurement-of-the-occlusion-pressure-of-the-isolated-periorbital-vein-100610072","NCT07222826","Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein","Non-invasive Intracranial Pressure Estimation by Measurement of the Occlusion Pressure of the Isolated Periorbital Vein (NICE-ICP)","Inclusion Criteria:\n\n* Male or female\n* Age \\> 18\n* Equipped with an invasive ICP monitor as part of standard of care\n\nExclusion Criteria:\n\n* Presence of facial and\u002For skull trauma that could hinder placement of the pneumatic mask or contraindicate ultrasound on the forehead\n* History of recent cranial surgery or hemicraniectomy\n* Active bleeding (proven or suspected)\n* History or known pathological condition or injury linked to the orbital socket influencingvenous outflow (e.g. Grave disease, tumor, inflammation, trauma, glaucoma, etc.)\n* History, or known vein stenosis in ophthalmic veins\u002Fcavernous sinus\n* Any other condition that would interfere with measurement technique and routine clinical care according to the judgment of the investigator.",{"count":57,"type":21},15,"INTERVENTIONAL",[60],"NA","Elevated intracranial pressure is a common complication of brain injury which means that the pressure within the skull rises above normal levels. The negative impact of increased intracranial pressure (ICP) on the prognosis of patients has been strongly shown in numerous studies and ICP-based treatment is associated with an important reduction of risk of death. Invasive ICP measurement methods are nowadays a standard of care in severe brain injury. The two available ways of measuring ICP require neurosurgical procedure to implant a catheter and probes within the brain and present risks and complications for the patient, such as infections and intracranial bleeding. In addition, invasive recording of ICP requires neurosurgical expertise and intensive care unit (ICU) facilities, limiting the application of ICP measurements to patients of the acute neuro-ICU (neuro-Intensive Care Unit) with acute brain damage requiring close surveillance to prevent further deterioration of neural tissue and disability. Non-invasive ICP monitoring benefits include no risk of complications seen in invasive monitoring, helping in deciding which patient needs invasive ICP monitoring, and providing ongoing long-term measurements of ICP without having to insert a new device every time. Although many non-invasive ICP measurement methods have been explored, to date, none of them have shown clinical success or usefulness. One under-explored window to ICP is the orbital vein, a small blood vessel located near your eye, which we think could provide a direct link to the intracranial pressure. The study device, called the CPMX3 system, is a non-invasive method to measure pressure in a superficial periorbital vein.",[25,26],"2025-10-28",{"date":65,"type":40},"2025-10-30",{"date":67,"type":40},"2025-09-30",{"date":69,"type":21},"2026-09-30",{"name":71,"class":47},"Compremium AG",1]