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NCT07074678

Prognostication of Recovery in Early Disorders of Consciousness Study

Enrolling by Invitation
NAAges 18+InterventionalDiagnostic
University of Pennsylvania
~150 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:Functional MRI (fMRI)

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of technologic covert consciousness
Measured over Baseline, during hospitalization (estimated approximately 1 month from brain injury)
+3 more outcomes measured

Conditions

Disorder of Consciousness
Comatose
Coma; Prolonged
Vegetative State
Minimally Conscious State

Explore related trials

ComaInjuries, Acute BrainMinimally conscious stateVegetative State

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • David J Fischer, MD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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
MRI contraindications
History of brain injury to neurological disease
History of diabetes, high blood pressure, kidney disease

What this trial measures

  • Detection of technologic covert consciousnessBaseline, during hospitalization (estimated approximately 1 month from brain injury)

    Brain activity during the delivery of commands, as compared to brain activity during rest, will be measured during the functional MRI scan. Brain activity that is significantly more associated with commands and that occurs in the premotor cortex or supplementary motor area will be interpreted as evidence of technologic covert consciousness.

  • Functional network connectivityBaseline, during hospitalization (estimated approximately 1 month from brain injury)

    Functional connectivity of brain networks will be measured during a resting state functional MRI sequence without noxious stimulation. Another sequence may be obtained during noxious stimulation.

  • Detection of behavioral covert consciousnessBaseline, during hospitalization (estimated approximately 1 month from brain injury), within 24 hours of the functional MRI

    The Coma Recovery Scale - Revised (CRS-R) will be used to assess the presence of behavioral covert consciousness, defined as the minimally conscious state minus (non-language based, but purposeful, behaviors), or the minimally conscious state plus (command-following, intelligible verbalization, and intentional communication). Higher scores (maximum 23) reflect higher levels of consciousness than lower scores (minimum 0).

  • Overt consciousness recovery based on Disability Rating ScaleThrough study completion: At hospital discharge (estimated approximately 1 month from brain injury), 3 months after hospital discharge, and 6 months after hospital discharge

    Overt consciousness, defined as command-following as measured with the Disability Rating Scale, will be evaluated at hospital discharge, and 3 and 6 months afterwards.