NCT07074678

Prognostication of Recovery in Early Disorders of Consciousness Study

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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?

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.

Conditions

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

Interventions

Type	Name	Description
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 computerized control. Additionally, the BOLD signal will be captured at rest to investigate functional neural networks.

Timeline

• Start date: 2023-03-08
• Primary completion: 2028-03-08
• Completion: 2029-03-08
• First posted: 2025-07-20
• Last updated: 2025-07-20

Locations

1 site across 1 country: United States