[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"unresponsive-wakefulness-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:unresponsive-wakefulness-syndrome":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,52,80,107],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":32,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100630260","fnirs-for-disorders-of-consciousness-100630260",false,"NCT07485361","fNIRS for Disorders of Consciousness","Functional Near-infrared Spectroscopy in Disorders of Consciousness: Protocol Testing and Pilot in Neuro-ICU Setting","Inclusion Criteria:\n\nHealthy Control Participants:\n\n* Age 18 years or older\n* Proficient in English language\n* Intact cognition\n* Montreal Cognitive Assessment (MoCA) score \\> 26\n\nDoC Patients:\n\n* Age 18 years or older\n* Proficient in English language\n* Surrogate decision maker available\n* Admission to the intensive care unit within 28 days\n* Documented Glasgow Coma Scale (GCS) score\n* Auditory Function subscale score ≥1 on the Coma Recovery Scale-Revised (CRS-R)\n\nExclusion Criteria:\n\nHealthy Control Participants:\n\n* Known baseline hearing impairment without available hearing aids\n* Neurological or psychiatric history\n\nDoC Patients:\n\n* Known baseline hearing impairment without available hearing aids\n* Inability to obtain informed consent\n* Extensive bilateral frontal injury on available imaging (CT\u002FMRI)\n* Patients who have undergone craniectomy surgery\n* IV sedation in the past 24 hours\n* Absent auditory startle response (\\\u003C1 from Auditory Function subscale score of CRS-R)",true,"ALL","18 Years",{"count":20,"type":21},55,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to learn whether functional near-infrared spectroscopy (fNIRS) can measure brain activity in healthy adults and in people with disorders of consciousness (DoC) in the neuro-intensive care unit (Neuro-ICU). DoC include conditions such as coma and minimally conscious state that occur after severe brain injury. These conditions make it difficult to assess a person's level of awareness because many clinical tests rely on observable behaviors such as speaking or moving, which are commonly impaired after brain injury.\n\nThe main questions the study aims to answer are:\n\n* Can fNIRS detect changes in brain activity in healthy adults when they receive sensory stimulation or perform mental tasks?\n* Can the same fNIRS protocol be used in patients with disorders of consciousness in the Neuro-ICU to measure brain responses and determine whether the method is feasible in this clinical setting?\n\nThe investigators will first study healthy adult volunteers to establish baseline brain responses and determine which tasks produce the most reliable signals. The protocol will then be applied to patients with disorders of consciousness admitted to the Neuro-ICU.\n\nParticipants will take part in a single research session lasting about 30 to 45 minutes while wearing the lightweight fNIRS headband that measures brain oxygen levels using near-infrared light. During the session, participants will:\n\n* Wear a non-invasive fNIRS headband placed on the forehead\n* Receive gentle sensory stimulation (for example, compression devices on the legs or hands)\n* Listen to sounds or spoken sentences\n* Perform guided mental tasks such as imagining walking through their home or imagining moving a limb\n\nThe study does not test a treatment and will not change medical care. The goal is to determine whether fNIRS can safely and reliably measure brain activity at the bedside and provide preliminary information that may help guide future research on improving the assessment of consciousness after brain injury.",[25,26,27,28,29,30,31],"Disorders of Consciousness Due to Severe Brain Injury","Disorders of Consciousness","Coma","Minimally Conscious State","Unresponsive Wakefulness Syndrome","Brain Injury","TBI Traumatic Brain Injury",[33,34,35,36,37,38],"Functional Near-Infrared Spectroscopy","Neurocritical Care","Functional Neuroimaging","Neuro Intensive Care Unit","Neurovascular Coupling","Consciousness Assessment","RECRUITING","2026-06-04",{"date":42,"type":43},"2026-06-08","ACTUAL",{"date":45,"type":43},"2026-05-01",{"date":47,"type":21},"2026-12",{"name":49,"class":50},"University of California, Los Angeles","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":60,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":51},"100628006","assessment-of-consciousness-with-crs-r-and-seconds-100628006","NCT07456020","Assessment of Consciousness With CRS-R and SECONDs","Assessment of Consciousness After Severe Brain Injury: Comparison of CRS-R and SECONDs","AssessConsc","Inclusion Criteria:\n\n* Admission to an intensive care unit (ICU) or intermediate\u002Fhigh-dependency care unit\n* Underlying etiology of brain injury: anoxic, traumatic, or vascular\n* Time since index event \\\u003C 90 days\n* Early Rehabilitation Barthel Index (ERBI) score \\\u003C 30 points\n\nExclusion Criteria:\n\n* History of prior brain injury\n* Pre-existing major psychiatric disorder\n* Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)\n* Ongoing sedation at the time of assessment\n* Interruption of rehabilitation treatment (transfer to an acute care hospital) for more than 14 days\n* isolation precautions due to multidrug-resistant organisms",{"count":61,"type":21},110,"Accurately determining the level of consciousness in patients with severe brain injury is essential for treatment planning, prognosis, and ethical decision-making. Clinically, levels of consciousness are differentiated into coma, Unresponsive Wakefulness Syndrome (UWS), and Minimally Conscious State (MCS) based on behavioral signs. Although behavioral assessment is considered the clinical gold standard, it is prone to misclassification. Research has shown that a substantial proportion of patients initially diagnosed with UWS may actually show signs of minimal consciousness, which is associated with better cognitive abilities and a more favorable prognosis.\n\nThe Coma Recovery Scale-Revised (CRS-R) is internationally recommended for diagnosing disorders of consciousness, but it is time-consuming and not free from diagnostic error. Repeated assessments can significantly improve diagnostic accuracy. To enhance feasibility in routine clinical practice, a shorter and more time-efficient assessment tool, the Simplified Evaluation of CONsciousness Disorders (SECONDs), was developed. This scale focuses on the behavioral signs most strongly associated with MCS and uses optimized testing procedures while maintaining high diagnostic accuracy.\n\nThe aim of this study is to further evaluate diagnostic approaches for assessing consciousness in patients with severe brain injury and to improve the reliability and clinical applicability of these assessments.",[25,28,29],[65,66,67,68,69,70],"Disorders of consciousness","Coma Recovery Scale-Revised","SECONDs","Acquired Brain Injury","Neurological rehabilitation","Critical ill patients","2026-03-09",{"date":73,"type":43},"2026-03-11",{"date":75,"type":43},"2026-02-01",{"date":77,"type":21},"2028-03-31",{"name":79,"class":50},"BDH-Klinik Hessisch Oldendorf",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":91,"conditions":92,"keywords":94,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":106,"locationsCount":51},"100627980","auditory-processing-in-doc-patients-100627980","NCT07455682","Auditory Processing in DOC Patients","Hierarchical Auditory Processing in Disorders of Consciousness: From Basic Deviance Detection to Semantic Integration","AUD-DOC","Inclusion Criteria:\n\n* Presence of a disorder of consciousness (Unresponsive Wakefulness Syndrome \\[UWS\\] or Minimally Conscious State \\[MCS\\]), classified using the Coma Recovery Scale-Revised (CRS-R) based on three assessments conducted on at least two separate days\n* Age between 18 and 80 years\n* Written informed consent provided by the patient's legal representative\n* Preserved brainstem auditory evoked potentials (BAEPs) on at least one side\n\nExclusion Criteria:\n\n* Ongoing sedation at the time of EEG assessment\n* Current treatment with medications known to significantly affect cortical functional state, including barbiturates, neuroleptics (antipsychotics), antiepileptic drugs, benzodiazepines, or comparable agents\n* Colonization with multidrug-resistant organisms requiring isolation precautions (e.g., 4MRGN)\n* Pregnancy\n* Impaired language comprehension (e.g., insufficient German language proficiency or aphasia)\n* Temporal bone fractures or severe infratentorial brain injury associated with unilateral or bilateral absence of auditory evoked potentials (AEPs)\n* Bilateral hearing impairment or deafness, or presence of a cochlear implant\n* Scalp wounds or conditions preventing placement of an EEG electrode cap","80 Years",{"count":90,"type":21},42,"This prospective observational study investigates whether electroencephalography (EEG) can improve the differentiation between unresponsive wakefulness syndrome (UWS) and minimally conscious state (MCS) in patients with severe acquired brain injury. The study further examines the association between EEG markers of auditory processing and long-term functional outcome at 12 months.",[93,29,28],"Disorder of Consciousness",[26,95,96,97,68,98,69],"Electroencephalography (EEG)","Event-related potential (ERP)","Coma Recovery Scale-Revised (CRS-R)","Critically ill patients","NOT_YET_RECRUITING","2026-03-03",{"date":102,"type":43},"2026-03-06",{"date":104,"type":21},"2026-04-15",{"date":77,"type":21},{"name":79,"class":50},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":114,"enrollmentInfo":115,"targetDuration":4,"studyType":117,"phases":118,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100581503","transcranial-temporal-interference-stimulation-in-severely-brain-injured-patients-with-disorders-of-consciousness-100581503","NCT06851156","Transcranial Temporal Interference Stimulation In Severely Brain Injured Patients With Disorders of Consciousness","An Exploratory Trial Evaluating Temporal Interference Stimulation of CM-pf In Patients With Disorders of Consciousness","Inclusion Criteria:\n\n* traumatic and nontraumatic etiology of VS\u002FUWS or MCS according to published diagnostic criteria.\n\nExclusion Criteria:\n\n* patients in coma, with less than 1 week after acute brain insult, with fluctuating diagnosis on baseline assessment, and with a metallic cerebral implant or pacemaker, and with epilepsy.","65 Years",{"count":116,"type":21},10,"INTERVENTIONAL",[119],"NA","The purpose of this academic lead study is to explore the effect of noninvasive neuromodulation of the CM-pf via tTIS for patients with disorders of consciousness.",[26,122,29,28],"Severe Brain Injury","2025-04-06",{"date":125,"type":43},"2025-04-09",{"date":127,"type":43},"2025-04-07",{"date":129,"type":21},"2025-12-31",{"name":131,"class":50},"Xijing Hospital",2]