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ENROLLING BY INVITATION
NCT07074678
NA

Prognostication of Recovery in Early Disorders of Consciousness Study

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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?

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2023-03-08

Completion Date

2029-03-08

Last Updated

2025-07-20

Healthy Volunteers

Yes

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

Locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States