Not Yet RecruitingNot Applicable

Prognostication of Recovery in Early Disorders of Consciousness Study

50 participantsStarted 2026-07-01

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * Acute brain injury (including ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, encephalitis) * 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 * Age 18 or greater. Exclusion Criteria: * 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.

What they're measuring

Glasgow Outcome Scale-Extended

Timeframe: 6 months following enrollment

Trial details

NCT IDNCT04692922

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-06-30

Contact for this trial

David Fischer, MD

617-724-6352 DFISCHER2@mgh.harvard.edu

View on ClinicalTrials.gov More Disorders of Consciousness Due to Severe Brain Injury trials