[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Emanuela Keller\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100419829","functional-near-infrared-spectroscopy-in-unconscious-patients-100419829",false,"NCT04746820","Functional Near-infrared Spectroscopy in Unconscious Patients","Prognostic Value of Functional Near-infrared Spectroscopy in Unconscious Neurocritical Care Patients- a Prospective Pilot Study","fNIRS","Inclusion Criteria - experimental group:\n\n* Patients of either sex with severe hemorrhagic, ischemic stroke or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation treated at the Institute of Intensive Care Medicine, University Hospital Zurich\n* Unconsciousness (GCS \\\u003C 9) or sedated to the severity of the disease (for the subgroup of patients included in the fNIRS-EEG measurement unconscious patients are defined as not responding to verbal stimuli. The motor response to pain should be one of the following: no response to pain \u002F extensor response \u002F flexor response \u002F localize to pain)\n* Age ≥ 18 years\n* Signed informed consent obtained from legal representative\n* Measurement logistically and technical possible within the first 7 days after admission\n\nInclusion Criteria - control group:\n\n* Subjects of either sex\n* Conscious (GCS = 15)\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria - experimental group:\n\n* Patients age \\\u003C 18 years\n* Positive pregnancy test for any female of childbearing potential or breast feeding female\n* Previous auditory complaints or any ear diseases\n* No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)\n* Any history of previous cerebral or brainstem disease\n* Concomitant instable critical illness (e.g. sepsis, multi-organ failure, hemodynamic or respiratory instability)\n* Acute status epilepticus\n* Clinical recovery (GCS ≥ 9) or death before enrolment of the study\n\nExclusion Criteria - control group:\n\n* Subjects age \\\u003C 18 years\n* Positive pregnancy test for any female of childbearing potential or breast feeding female\n* Previous auditory complaints or any ear diseases\n* No response detectable at Erb's point in SSEP (e.g. due to peripheral nerve lesions, edema etc.)\n* Any history of previous cerebral or brainstem disease",true,"ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","The study design is a single-center prospective pilot study. Hypothesis: Results of cerebral fNIRS examination in unconscious patients with severe hemorrhagic or ischemic stroke in the ICU are congruent with the results of SSEP and AEP. Hence, making it a potential prognostic tool for unconscious ICU patients.\n\nIn a specific subgroup of unconscious patients after cardiac arrest and cardiopulmonary resuscitation the fNIRS measurement is congruent with the results of electroencephalography (EEG).\n\nThe primary purpose of this study is to evaluate the agreement of the results of fNIRS examination to those of evoked potentials and EEG in unconscious ICU patients with severe hemorrhagic, or ischemic strokes or hypoxic brain injury after cardiac arrest and cardiopulmonary resuscitation.\n\nfNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects.\n\nTo compare fNIRS with evoked potentials there are two test phases:\n\n1. The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP\n2. The cerebral response to an auditory stimulus is measured by fNIRS and AEP\n\nTo avoid biases the following has to be considered:\n\n* The timing of the measurements plays an important role. A time difference between compared measurements can influence the outcome significantly due to deterioration or recovery of the neuronal network during the time gap. Therefore, fNIRS and evoked potentials will be measured simultaneously.\n* If the compared measurement methods are conducted by the same researcher the possibility of bias is high. Hence, two different researcher will conduct each one measurement without knowing the results of each other during the measurement.",[28,29],"Nervous System Diseases","Healthy Subjects",[31,32,33,34,35,36],"severe cerebral hemorrhage","ischemic stroke","unconscious neurocritical care patients","functional near-infrared spectroscopy","evoked potentials","electroencephalography","RECRUITING","2026-04-21",{"date":40,"type":41},"2026-04-27","ACTUAL",{"date":43,"type":41},"2020-01-15",{"date":45,"type":22},"2026-12-31",{"name":47,"class":48},"Emanuela Keller","OTHER",2,""]