Prognostication of Recovery in Early Disorders of Consciousness Study
Enrolling by invitation · Not applicable
Conditions studied: Disorder of Consciousness, Comatose, Coma; Prolonged, Vegetative State, Minimally Conscious State
In brief
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?
Key facts
- Study ID
- NCT07074678
- Run by
- University of Pennsylvania
- People needed
- 150
- Starts
- 2023-03-08
- Expected to finish
- 2029-03-08
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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