Prognostication of Recovery in Early Disorders of Consciousness Study

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
University of Pennsylvania
Study ID
NCT07074678
Status
Enrolling By Invitation

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Functional MRI (fMRI) — DIAGNOSTIC_TEST
    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.

Study Details

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 Dates

Start date
Mar 8, 2023
Status verified
Jul 2025
Primary completion
Mar 8, 2028
Completion
Mar 8, 2029

Study Design

Enrollment
150 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Single arm
    Patients and healthy controls will undergo functional MRI, which may include auditory and noxious stimulation.

Primary Outcome Measure

Detection of technologic covert consciousness [ Time Frame: Baseline, during hospitalization (estimated approximately 1 month from brain injury) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104-

Find similar trials in Philadelphia, PA

By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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