[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100415690":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":25,"centralContacts":29,"locations":10,"responsibleParty":38,"collaborators":10,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":10,"enrollmentInfo":50,"targetDuration":10,"studyType":53,"phases":10,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":61,"whyStopped":10,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":10},{"fullName":5,"class":6},"Massachusetts General Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with disorders of consciousness",null,"patients with a diagnosis of coma, vegetative state, or minimally conscious state minus (i.e. minimally conscious state without language function)",[13,14],"Diagnostic Test: MRI","Diagnostic Test: EEG",[16,21],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":10},"DIAGNOSTIC_TEST","MRI","MRI will include structural sequences (e.g., T1 weighted imaging, T2 weighted imaging, T2 FLAIR, diffusion weighted imaging with apparent diffusion coefficient, susceptibility weighted imaging, and diffusion tensor imaging). Using the structural sequences we will make note of the types of brain lesions (e.g., ischemic stroke, hemorrhage, hypoxic-ischemic brain injury), and the locations of these brain lesions. MRI will also include fMRI under three conditions: while the patient is at rest (to evaluate resting state functional connectivity), while the patient is exposed to auditory stimuli (to evaluate passive fMRI responses to stimuli), and while the patient is asked to follow commands (to evaluate active fMRI responses to tasks).",[9],{"type":17,"name":22,"description":23,"armGroupLabels":24,"otherNames":10},"EEG","The EEG will include resting, stimulus-based, and task-based assessments of brain function.",[9],[26],{"name":27,"affiliation":5,"role":28},"Brian L Edlow, MD","PRINCIPAL_INVESTIGATOR",[30,35],{"name":31,"role":32,"phone":33,"phoneExt":10,"email":34},"David Fischer, MD","CONTACT","617-724-6352","DFISCHER2@mgh.harvard.edu",{"name":36,"role":32,"phone":10,"phoneExt":10,"email":37},"Yelena Bodien, PhD","ybodien@mgh.harvard.edu",{"type":28,"investigatorFullName":39,"investigatorTitle":40,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"Brian L. Edlow, M.D.","Principal Investigator","100415690","prognostication-of-recovery-in-early-disorders-of-consciousness-study-100415690",false,"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.","ALL","18 Years",{"count":51,"type":52},50,"ESTIMATED","OBSERVATIONAL","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.",[56],"Disorders of Consciousness Due to Severe Brain Injury",[58,59,60],"Disorders of consciousness","Advanced neuroimaging","Neuroprognostication","NOT_YET_RECRUITING","2026-04-21",{"date":64,"type":65},"2026-04-24","ACTUAL",{"date":67,"type":52},"2026-07-01",{"date":69,"type":52},"2032-06-30",{"name":5,"class":6}]