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Assessing Covert Consciousness in Unresponsive Patients

Primary Purpose

Consciousness Disorders

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
EEG recording
Anesthetics, Intravenous
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Consciousness Disorders

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients admitted to the intensive care unit at Hamilton General Hospital who:

    • Clinical status consistent with UWS (no responsiveness to commands)
    • Clinical status consistent with MCS (minimal response to at least one command)
    • Presence of an endotracheal tube (ETT) or a tracheostomy tube
    • Between 18 and 50 years of age

Exclusion Criteria:

  • • Elevated intracranial pressure (ICP)

    • Hepatic or renal failure
    • Hemodynamic instability
    • Active vasopressor therapy
    • Previous open-head injury
    • Previous intracranial pathology requiring neurosurgical interventions in the past 72 hours
    • Anticipated ICU stay < 24 hours
    • Documented allergy to propofol
    • Pregnancy
    • BMI > 35 kg/m2
    • Anyone who is deemed medically unsuitable for this study by the attending intensivist
    • Patients who are already in a medically-induced coma for intracranial hypertension or status epilepticus

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Placebo Comparator

    Active Comparator

    Experimental

    Arm Label

    Control 1 (negative control)

    Control 2 (positive control)

    Target Population

    Arm Description

    Individuals with a diagnosis of UWS without neural markers of consciousness

    Individuals with a diagnosis of MCS, who are behaviourally responsive and who present neural markers of consciousness

    Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness

    Outcomes

    Primary Outcome Measures

    Asymmetry in feedback vs. feedforward network connectivity
    EEG networks will be monitored pre, during and post anesthesia. Directed connectivity will be calculated using phase lag index (PLI) and symbolic transfer entropy (STE) between all combinations of EEG sensors. Average values of feedback connectivity (e.g. from the frontal regions to parietal and occipital regions) will be compared to average values of feedforward connectivity (e.g. from parietal and occipital regions to frontal regions). Positive asymmetry will be correlated to the presence of conscious awareness and negative asymmetry will be correlated to the absence of conscious awareness.

    Secondary Outcome Measures

    Presence of P300 and N400 event-related potentials
    EEG signals will be processed to extract the event-related EEG reactions to the auditory stimulation paradigm. Signals will be average 300 ms post-stimuli and 400 ms post-stimuli to assess the presence of the P300 and N400 event-related potentials. Presence of these event-related potentials will be correlated to the presence of conscious awareness and absence of these event-related potentials will be correlated to the absence of conscious awareness.

    Full Information

    First Posted
    January 8, 2016
    Last Updated
    October 25, 2016
    Sponsor
    University of Michigan
    Collaborators
    McGill University, McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02659228
    Brief Title
    Assessing Covert Consciousness in Unresponsive Patients
    Official Title
    Assessing the Potential for 'Covert Consciousness' in Unresponsive Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Michigan
    Collaborators
    McGill University, McMaster University

    4. Oversight

    5. Study Description

    Brief Summary
    In this study, the investigators explore anesthesia as a tool for providing further insight into the level of consciousness of individuals with a clinical diagnosis of unresponsive wakefulness syndrome (UWS), but who possess some neurophysiological signatures of conscious awareness. This group, who could potentially be conscious, will herein be referred to as the target population. Our goal is to assess whether or not neurological patterns of consciousness in the target population respond to anesthesia in a similar manner to neurologically compromised individuals with known consciousness (e.g. those in minimally conscious state (MCS). In healthy controls, propofol-induced unconsciousness results in an elimination of the mismatch negativity event-related brain potential (ERP) and a diminished directed connectivity. The investigators hypothesize that at doses well below those required for surgery, anesthesia will have similar effects on these neural patterns in neurologically compromised patients with the potential for conscious awareness, but will not affect these patterns in those who lack consciousness.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Consciousness Disorders

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Control 1 (negative control)
    Arm Type
    Placebo Comparator
    Arm Description
    Individuals with a diagnosis of UWS without neural markers of consciousness
    Arm Title
    Control 2 (positive control)
    Arm Type
    Active Comparator
    Arm Description
    Individuals with a diagnosis of MCS, who are behaviourally responsive and who present neural markers of consciousness
    Arm Title
    Target Population
    Arm Type
    Experimental
    Arm Description
    Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness
    Intervention Type
    Device
    Intervention Name(s)
    EEG recording
    Intervention Description
    EEG recording with anesthetic (DIPRIVAN)
    Intervention Type
    Drug
    Intervention Name(s)
    Anesthetics, Intravenous
    Intervention Description
    The participant will receive an intravenous infusion of propofol (DIPRIVAN Injectable Emulsion USP 1%, AstraZeneca).
    Primary Outcome Measure Information:
    Title
    Asymmetry in feedback vs. feedforward network connectivity
    Description
    EEG networks will be monitored pre, during and post anesthesia. Directed connectivity will be calculated using phase lag index (PLI) and symbolic transfer entropy (STE) between all combinations of EEG sensors. Average values of feedback connectivity (e.g. from the frontal regions to parietal and occipital regions) will be compared to average values of feedforward connectivity (e.g. from parietal and occipital regions to frontal regions). Positive asymmetry will be correlated to the presence of conscious awareness and negative asymmetry will be correlated to the absence of conscious awareness.
    Time Frame
    3 hours
    Secondary Outcome Measure Information:
    Title
    Presence of P300 and N400 event-related potentials
    Description
    EEG signals will be processed to extract the event-related EEG reactions to the auditory stimulation paradigm. Signals will be average 300 ms post-stimuli and 400 ms post-stimuli to assess the presence of the P300 and N400 event-related potentials. Presence of these event-related potentials will be correlated to the presence of conscious awareness and absence of these event-related potentials will be correlated to the absence of conscious awareness.
    Time Frame
    3 hours

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients admitted to the intensive care unit at Hamilton General Hospital who: Clinical status consistent with UWS (no responsiveness to commands) Clinical status consistent with MCS (minimal response to at least one command) Presence of an endotracheal tube (ETT) or a tracheostomy tube Between 18 and 50 years of age Exclusion Criteria: • Elevated intracranial pressure (ICP) Hepatic or renal failure Hemodynamic instability Active vasopressor therapy Previous open-head injury Previous intracranial pathology requiring neurosurgical interventions in the past 72 hours Anticipated ICU stay < 24 hours Documented allergy to propofol Pregnancy BMI > 35 kg/m2 Anyone who is deemed medically unsuitable for this study by the attending intensivist Patients who are already in a medically-induced coma for intracranial hypertension or status epilepticus

    12. IPD Sharing Statement

    Learn more about this trial

    Assessing Covert Consciousness in Unresponsive Patients

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