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Enrolling By Invitation
NCT07074678
Prognostication of Recovery in Early Disorders of Consciousness Study
Conditions: Disorder of Consciousness, Comatose, Coma; Prolonged, Vegetative State, Minimally Conscious State
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 150
Sponsor: University of Pennsylvania
Location: Hospital of the University of Pennsylvania Philadelphia Pennsylvania
Summary
The goal of this study is to determine the extent to which neuroimaging metrics (e.g., functional MRI) are associated with the current level of consciousness, and future consciousness recovery, in patients with disorders of consciousness resulting from acute brain injury. The main questions this study aims to answer are:
How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with current level of consciousness? How do functional MRI findings (e.g., covert consciousness and network connectivity) associate with future recovery of consciousness? How does noxious stimulation affect the detection of covert consciousness and functional brain network connectivity?
Eligibility Criteria
For patients:
Inclusion Criteria:
* Acute brain injury (including, but not limited to ischemic stroke, intracranial hemorrhage, anoxic brain injury, traumatic brain injury, or encephalitis)
* Inability to follow commands due to a disorder of consciousness (comatose, vegetative, or minimally conscious state) caused by the underlying brain injury
* Age 18 or greater
* Enrolled within 28 days of brain injury
Exclusion Criteria:
* Imminent death (as indicated, for example, by planned transition to palliative measures, brain death testing, or severe medical instability)
* MRI contraindications would exclude patients from imaging component of study
For healthy controls:
Exclusion Criteria:
* MRI contraindications
* History of brain injury to neurological disease
* History of diabetes, high blood pressure, kidney disease
Source: ClinicalTrials.gov (NCT07074678). StuddyBuddy aggregates publicly available trial information.