An interventional study of EEG recording and Anesthetics, Intravenous in Consciousness Disorders, sponsored by University of Michigan. Status unknown. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2016-10-27.
Sponsored by University of Michigan · Not applicable, Interventional, and Basic science
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.
244 studies on the registry are indexed under Consciousness Disorders; 104 are open to participants now.
This study's planned enrollment of 60 is above the median of 44 across 155 interventional studies indexed under Consciousness Disorders.
Browse Consciousness Disorders studies →University of Michigan is the lead sponsor of 1,503 studies on the registry; 189 are open to participants now.
Of its 167 completed or terminated interventional studies of FDA-regulated products, 132 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients admitted to the intensive care unit at Hamilton General Hospital who:
Exclusion Criteria:
Elevated intracranial pressure (ICP)
Individuals with a diagnosis of UWS without neural markers of consciousness
Device: EEG recording
Individuals with a diagnosis of MCS, who are behaviourally responsive and who present neural markers of consciousness
Device: EEG recording
Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness
Device: EEG recording · Drug: Anesthetics, Intravenous
EEG recording with anesthetic (DIPRIVAN)
The participant will receive an intravenous infusion of propofol (DIPRIVAN Injectable Emulsion USP 1%, AstraZeneca).
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.
Time frame: 3 hours
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.
Time frame: 3 hours
No study locations are listed for this record.
The record gives a start of Dec 2016 and a primary completion of Jun 2017. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Anesthetics, Intravenous