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Enrolling by invitation NCT07074678

Prognostication of Recovery in Early Disorders of Consciousness Study

No phase Interventional Disorder of Consciousness Comatose Coma; Prolonged Vegetative State

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Functional MRI (fMRI).
Who it may be relevant to
Registry conditions: Disorder of Consciousness, Comatose, Coma; Prolonged, Vegetative State. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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?

Detailed 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.

Interventions

  • Diagnostic test Functional MRI (fMRI)
    Research MRI, which will include both structural and functional sequences, will either be collected independently, or in conjunction with clinically-indicated sequences. Functional MRI captures the blood oxygen level dependent (BOLD) signal that reflects brain activity. A subset of the PREDICT study fMRI will include sequences with auditory and/or noxious stimulation. Noxious stimulation will be delivered with an MRI-compatible device that delivers intermittent nailbed pressure under computerize

Primary outcome measures

  • Detection of technologic covert consciousness [Time frame: Baseline, during hospitalization (estimated approximately 1 month from brain injury)]
  • Functional network connectivity [Time frame: Baseline, during hospitalization (estimated approximately 1 month from brain injury)]
  • Detection of behavioral covert consciousness [Time frame: Baseline, during hospitalization (estimated approximately 1 month from brain injury), within 24 hours of the functional MRI]
  • Overt consciousness recovery based on Disability Rating Scale [Time frame: Through study completion: At hospital discharge (estimated approximately 1 month from brain injury), 3 months after hospital discharge, and 6 months after hospital discharge]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Hospital of the University of Pennsylvania — Philadelphia

Identifiers

NCT: NCT07074678 · 852381 · 1K23NS136745-01A1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗