Prognostication of Recovery in Early Disorders of Consciousness Study (PREDICT)

University of Pennsylvania

Status: Invitation-only

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

Treatments: Diagnostic Test: Functional MRI (fMRI)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07074678

852381

1K23NS136745-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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?

Full description

Patients with disorders of consciousness (lacking overt signs of consciousness such as command-following) due to acute brain injury will be identified and enrolled via the Recovery of Consciousness Via Evidence-Based Medicine and Research (RECOVER) Program. Patients in the study will undergo a detailed behavioral consciousness assessment (with the Coma Recovery Scale - Revised [CRS-R]), conducted by specially trained personnel, as well as a task-based functional MRI with auditory stimulation (motor commands) to assess for technologic covert consciousness (the willful modulation of brain activity to command) and functional brain network connectivity. For a subset of patients, the functional MRI will be performed with and without noxious stimulation, during the same scanning session. Patients will undergo repeat behavioral evaluations at hospital discharge, and 3 and 6 months after, to assess for overt consciousness recovery.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Single arm

Experimental group

Description:

Patients and healthy controls will undergo functional MRI, which may include auditory and noxious stimulation.

Treatment:

Diagnostic Test: Functional MRI (fMRI)