Assessing Covert Consciousness in Unresponsive Patients

Not Applicable

• Conditions: Consciousness Disorders
• Interventions: Device: EEG recording; Drug: Anesthetics, Intravenous

• Registration Number: NCT02659228
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-14
• Study First Posted: 2016-01-20
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-25
• Last Update Posted: 2016-10-27
• Study Start: 2016-12
• Primary Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control 2 (positive control)	EEG recording	Individuals with a diagnosis of MCS, who are behaviourally responsive and who present neural markers of consciousness
Control 1 (negative control)	EEG recording	Individuals with a diagnosis of UWS without neural markers of consciousness
Target Population	EEG recording	Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness
Target Population	Anesthetics, Intravenous	Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness

Primary Outcome Measures

Name	Time	Method
Asymmetry in feedback vs. feedforward network connectivity	3 hours	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

Name	Time	Method
Presence of P300 and N400 event-related potentials	3 hours	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.