[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"disorders-of-consciousness-due-to-severe-brain-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:disorders-of-consciousness-due-to-severe-brain-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,53,88,111,135,163,190,212],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100614262","promoting-recovery-after-brain-injury-using-focused-ultrasound-100614262",false,"NCT07277309","Promoting Recovery After Brain Injury Using Focused Ultrasound","ReBOUND","Inclusion Criteria:\n\n* Brain injury resulting in DoC diagnosis, following international guidelines\n* At least 18 years of age\n* Legally authorized representative (surrogate) available to consent\n\nExclusion Criteria:\n\n* History of neurological disorder other than the brain injury\n* Metal implant or other condition precluding MRI\n* Manifest continuous spontaneous movement (which would prevent safe\u002Fsuccessful MRI)\n* Participation in concurrent therapeutic study\n* Pregnancy","ALL","18 Years","79 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"NA","The overall aim of this study is to develop an intervention that can help recovery in patients surviving severe brain injury but failing to fully recover. In particular, this project aims to (1) determine neurobehavioral responses to low-intensity focused ultrasound (LIFUP) in patients with disorders of consciousness (DoC) following brain injury, (2) determine neurophysiologic (EEG) responses to LIFUP in patients with DoC and (3) identify and evaluate ethical perspectives of patient representatives (family members and surrogate decision-makers) surrounding investigation of therapeutic neuromodulation technologies such as LIFUP in patients with DoC.",[27,28],"Consciousness Disorders","Disorders of Consciousness Due to Severe Brain Injury",[30,31,32,33,34,35,36,37,38,39],"Disorder of Consciousness","Vegetative State","Minimally Conscious State","Minimally Conscious State Plus","Minimally Conscious State Minus","Traumatic Brain Injury","CVA (Cerebrovascular Accident)","Anoxia, Brain","Thalamic Infarction","Coma; Prolonged","RECRUITING","2026-06-12",{"date":43,"type":44},"2026-06-15","ACTUAL",{"date":46,"type":44},"2026-05-26",{"date":48,"type":21},"2029-07",{"name":50,"class":51},"Massachusetts General Hospital","OTHER",2,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":4,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":61,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":64,"conditions":65,"keywords":71,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":87},"100630260","fnirs-for-disorders-of-consciousness-100630260","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,{"count":62,"type":21},55,"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.",[28,66,67,32,68,69,70],"Disorders of Consciousness","Coma","Unresponsive Wakefulness Syndrome","Brain Injury","TBI Traumatic Brain Injury",[72,73,74,75,76,77],"Functional Near-Infrared Spectroscopy","Neurocritical Care","Functional Neuroimaging","Neuro Intensive Care Unit","Neurovascular Coupling","Consciousness Assessment","2026-06-04",{"date":80,"type":44},"2026-06-08",{"date":82,"type":44},"2026-05-01",{"date":84,"type":21},"2026-12",{"name":86,"class":51},"University of California, Los Angeles",1,{"id":89,"slug":90,"hasResults":11,"nctId":91,"briefTitle":92,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":96,"targetDuration":4,"studyType":22,"phases":98,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},"100588280","ultrasound-stimulation-for-patients-in-a-disorder-of-consciousness-100588280","NCT06939348","Ultrasound Stimulation for Patients in a Disorder of Consciousness","Safety and Efficacy of Thalamic Focused Ultrasound Stimulation (tFUS) for Promoting Recovery After Severe Traumatic Brain Injury","tFUS","Inclusion Criteria:\n\n1. Diagnosis of DoC, following international guidelines, as assessed with the CRS-R.\n2. Prolonged status (\\>28days post-injury)\n3. If on a psychotropic medication regimen, that regimen will be stable for at least 4 weeks prior to entry to the study and the patient will be willing to remain on a stable regimen during the protocol.\n4. legally authorized representative available to consent for the patient to participate in the study\n\nExclusion Criteria:\n\n1. History of neurological disorder (other than the brain injury).\n2. Metal implant or other condition precluding safe entry in the MR-environment.\n3. Manifest continuous spontaneous movement (which would prevent safe\u002Fsuccessful imaging).\n4. Participation in another concurrent clinical trial.\n5. Need for mechanical ventilation.\n6. Craniotomy (no bone flap).\n7. Cranioplasty spanning the left temporal bone window.",{"count":97,"type":21},60,[24],"The overall aim of this study is to develop an intervention that can help recovery in patients surviving severe brain injury but failing to fully recover. In particular, this multicenter project aims to (1) establish short-term efficacy of tFUS as a therapeutic to promote recovery in patients with prolonged DoC as compared to sham treatment, (2) establish dose-related safety and efficacy of tFUS as a therapeutic intervention in prolonged DoC patients and (3) explore preliminary predictors and biomarkers of susceptibility and response to thalamic sonication.",[27,28],[30,31,32,33,34,35,36,37,38,39],"2026-05-18",{"date":104,"type":44},"2026-05-22",{"date":106,"type":44},"2025-04-26",{"date":108,"type":21},"2028-09-29",{"name":86,"class":51},4,{"id":112,"slug":113,"hasResults":11,"nctId":114,"briefTitle":115,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":118,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":120,"conditions":121,"keywords":122,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":4},"100415690","prognostication-of-recovery-in-early-disorders-of-consciousness-study-100415690","NCT04692922","Prognostication of Recovery in Early Disorders of Consciousness Study","PREDICT","Inclusion Criteria:\n\n* Acute brain injury (including ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, encephalitis)\n* Inability to follow commands, speak intelligibly, or communicate (i.e., diagnosis of coma, vegetative state, or minimally conscious state minus) due to the underlying brain injury and within 28 days of the brain injury\n* Age 18 or greater.\n\nExclusion Criteria:\n\n* Subjects will be excluded if they do not speak English (given the reliance on verbal questionnaires conducted in English) or if they regain the ability to follow commands, speak intelligibly or communicate (i.e., improves to minimally conscious state plus or greater) before they undergo MRI or EEG.",{"count":119,"type":21},50,"By collecting multimodal metrics (e.g., clinical factors, neuroimaging, and EEG) in the early phase of severe brain injury (i.e., during the acute hospitalization when a patient has impaired consciousness), and measuring the patients' recovery of consciousness, function, and quality of life in the late phase (at 6 months following the brain injury), we aim to construct an algorithm that synthesizes the results of these metrics to help predict recovery.",[28],[123,124,125],"Disorders of consciousness","Advanced neuroimaging","Neuroprognostication","NOT_YET_RECRUITING","2026-04-21",{"date":129,"type":44},"2026-04-24",{"date":131,"type":21},"2026-07-01",{"date":133,"type":21},"2032-06-30",{"name":50,"class":51},{"id":136,"slug":137,"hasResults":11,"nctId":138,"briefTitle":139,"officialTitle":140,"acronym":141,"eligibilityCriteria":142,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":143,"enrollmentInfo":144,"targetDuration":4,"studyType":22,"phases":146,"briefSummary":149,"conditions":150,"keywords":151,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":87},"100634123","phase-2-transcutaneous-electrical-acupoint-stimulation-at-jing-well-points-for-disorders-of-consciousness-100634123","NCT07535593","Transcutaneous Electrical Acupoint Stimulation at Jing-Well Points for Disorders of Consciousness","Efficacy and Safety of Transcutaneous Electrical Acupoint Stimulation at Hand Jing-Well Points in Patients With Disorders of Consciousness：A Multicenter Randomized Controlled Trial","Wells-DoC II","Inclusion Criteria:\n\n* Age: 18-80 years old;\n* From 7 to 90 days since brain injury;\n* Diagnosed in VS\u002FUWS or MCS as defined by at least two CRS-R assessments performed during the screening period\n* Acquired cerebral damage of known etiology\n* Intact hand skin\n* Informed consent given by the legal surrogate\n\nExclusion Criteria:\n\n* Patients who continuously receive sedative drugs and Na+ or Ca2+ channel blockers (e.g., carbamazepine) or NMDA receptor antagonists (e.g., dextromethorphan)\n* History of previous serious、progressive neurological disorder prior to the brain injury;\n* Epilepsy and seizure\n* Unstable vital signs or life-threatening comorbidities\n* Implanted devices: including cardiac pacemakers or implantable cardioverter-defibrillators (ICDs), deep brain stimulators, ventriculoperitoneal (VP) shunts, and other indwelling electronic or neurosurgical implants.\n* Documented pregnancy","80 Years",{"count":145,"type":21},160,[147,148],"PHASE2","PHASE3","Effective treatment options for disorders of consciousness (DoC) remain limited, and available interventions show heterogeneous efficacy. To date, limited evidences support the use of amantadine and transcranial direct current stimulation in this population.\n\nBloodletting puncture (BP) at the hand twelve Jing-Well points (HTWPs) has been traditionally used in China as an empirical therapy for DoC; however, its efficacy has not been established by robust clinical evidence. Transcutaneous electrical acupoint stimulation (TEAS) provides a modern, noninvasive alternative for acupoint stimulation. The Wells-DoC trial, a multicenter, randomized, controlled, open-label study with blinded endpoint assessment, provided preliminary evidence that TEAS applied at the hand twelve Jing-Well points was associated with a numerically higher proportion of consciousness improvement in patients with DoC, although the difference did not reach statistical significance. These findings support the need for further evaluation in an adequately powered randomized controlled trial.\n\nThe Wells-DoC II trial is a multicenter, randomized, controlled, double-blind clinical trial designed to evaluate the efficacy and safety of TEAS at the twelve Jing-Well points of the hand in patients with DoC. The primary objective of the Wells-DoC II trial is to determine whether TEAS applied at the twelve Jing-Well points of the hand improves consciousness in adults with DoC. The primary endpoint is the proportion of patients achieving consciousness improvement after 14 consecutive days of treatment, compared between the TEAS group and the sham stimulation (placebo control) group.\n\nThe secondary objectives are to assess the effects of TEAS versus sham stimulation on: (1) changes in Coma Recovery Scale-Revised (CRS-R) scores at 7 and 14 days; (2) change in ABCD model classification at day 14; and (3) functional outcomes measured by the Glasgow Outcome Scale-Extended (GOSE) at 3 and 6 months after enrollment.\n\nA total of 160 patients will be recruited over a 28-month period.",[28],[152,153,66],"Transcutaneous Electrical Acupoint Stimulation","Hand Jing-Well Points","2026-04-14",{"date":156,"type":44},"2026-04-17",{"date":158,"type":21},"2026-04",{"date":160,"type":21},"2028-12",{"name":162,"class":51},"Xijing Hospital",{"id":164,"slug":165,"hasResults":11,"nctId":166,"briefTitle":167,"officialTitle":168,"acronym":169,"eligibilityCriteria":170,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":171,"targetDuration":4,"studyType":63,"phases":4,"briefSummary":173,"conditions":174,"keywords":175,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":87},"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":172,"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.",[28,32,68],[123,176,177,178,179,180],"Coma Recovery Scale-Revised","SECONDs","Acquired Brain Injury","Neurological rehabilitation","Critical ill patients","2026-03-09",{"date":183,"type":44},"2026-03-11",{"date":185,"type":44},"2026-02-01",{"date":187,"type":21},"2028-03-31",{"name":189,"class":51},"BDH-Klinik Hessisch Oldendorf",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":196,"eligibilityCriteria":197,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":87},"100602723","consciousness-prognosis-evaluation-using-olfactory-stimulations-in-comatose-patients-100602723","NCT07127224","Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients)","Consciousness Prognosis Evaluation Using Olfactory Stimulations in Comatose Patients","CEOS","Inclusion Criteria:\n\n* Admission to neuro-intensive care unit (neuro-ICU)\n* Age ≥ 18 years\n* Patients with persistent disorders of consciousness defined by an abnormal CRS-R score (\\\u003C16) at 72 hours after sedation withdrawal and spontaneous ventilation\n* Consent obtained from legal representatives or activation of emergency waiver\n* Patient covered by or affiliated with a social security system\n\nExclusion Criteria:\n\n* Pregnancy\n* Brain death\n* Pre-existing ENT or olfactory bulb pathologies that may affect olfactory functions\n* Acute or chronic peripheral neurological diseases that may alter evoked potentials\n* Known neurodegenerative diseases (e.g., Parkinson's disease, Alzheimer's disease)\n* Patients under legal guardianship or protective supervision (safeguard or protection measures)",{"count":199,"type":21},96,[24],"The goal of this observational study is to determine whether the clinical response to olfactory stimulation (known as the \"sniff\" response) can help predict 3-month neurological outcomes in ICU patients with persistent disorders of consciousness after sedation withdrawal, regardless of the reason for admission or the initial severity.\n\nThe main questions this study aims to answer are:\n\n* Can the \"sniff\" response to olfactory stimulation predict neurological outcomes at 3 months?\n* Is this response a better prognostic indicator than commonly used neurophysiological tests? Researchers will compare the results obtained from olfactory stimulation with those from somatosensory and auditory stimulations to determine whether the olfactory method provides additional or superior prognostic value.\n\nParticipants will receive additional olfactory stimuli as part of the neurophysiological evaluation for prognostic purposes and be followed up at 3 months for clinical, neurological, and functional evaluation",[28],"2025-08-11",{"date":205,"type":44},"2025-08-17",{"date":207,"type":44},"2024-02-05",{"date":209,"type":21},"2027-05-05",{"name":211,"class":51},"Centre Hospitalier St Anne",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":216,"acronym":4,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":218,"targetDuration":219,"studyType":63,"phases":4,"briefSummary":220,"conditions":221,"keywords":4,"overallStatus":126,"whyStopped":4,"lastUpdateSubmitDate":222,"lastUpdatePostDateStruct":223,"startDateStruct":225,"completionDateStruct":227,"leadSponsor":229,"locationsCount":4},"100587013","the-prediction-value-of-combined-electroencephalographic-and-electromyographic-response-in-disorders-of-consciousness-100587013","NCT06922864","the Prediction Value of Combined Electroencephalographic and Electromyographic Response in Disorders of Consciousness","Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Brain damage lasts 28 to 90 days.\n3. It meets the diagnostic criteria of unresponsive arousal syndrome\u002Fvegetative state (UWS\u002FVS) or microconscious state (MCS).\n\n   Diagnostic criteria for UWS\u002FVS: loss of cognitive function and inability to execute commands; There is a sleep-wake cycle; Inability to understand or express language; The ability to open eyes automatically or in response to stimulation; Can be purposeless eye following movement; The functions of hypothalamus and brainstem were basically preserved.\n\n   MCS diagnostic criteria: simple instructions can be executed; Yes\u002Fno (whether correct or not) can be expressed by gesture or speech; Have an understandable language; Purposeful behavior (including activity or emotional response) with more than one can diagnose MCS.\n4. All subjects' legal guardians sign informed consent forms.\n\nExclusion Criteria:\n\n1. Spinal cord T1 and above plane injury, peripheral nerve injury and so on affect nerve conduction;\n2. The impact of injury on palms and soles of feet;\n3. History of developmental, psychiatric, or neurological disorders prior to brain injury.\n4. Deep sedation within 72 hours, including the use of general anesthesia.\n5. Increased intracranial pressure, liver\u002Fkidney failure, and hemodynamic instability within 72 hours.\n6. Severe co-existing systemic diseases with limited life expectancy.",{"count":20,"type":21},"6 Months","The goal of this observation study is to learn about the prediction value of combined electroencephalographic and electromyographic response in disorders of consciousness.\n\nThe main ways of stimulation is thermal and itch. Six months after inclusion in the study, patients were classified according to the Glasgow Outcome Scale Extended, (GOSE).",[28],"2025-04-03",{"date":224,"type":44},"2025-04-11",{"date":226,"type":21},"2025-04-15",{"date":228,"type":21},"2026-12-31",{"name":230,"class":51},"KY20242235jiangwen"]