- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02659228
Assessing Covert Consciousness in Unresponsive Patients
October 25, 2016 updated by: George Mashour, University of Michigan
Assessing the Potential for 'Covert Consciousness' in Unresponsive Patients
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Control 1 (negative control)
Individuals with a diagnosis of UWS without neural markers of consciousness
|
EEG recording with anesthetic (DIPRIVAN)
|
Active Comparator: Control 2 (positive control)
Individuals with a diagnosis of MCS, who are behaviourally responsive and who present neural markers of consciousness
|
EEG recording with anesthetic (DIPRIVAN)
|
Experimental: Target Population
Individuals with a clinical diagnosis of UWS, but who possess some neurophysiological signatures of conscious awareness
|
EEG recording with anesthetic (DIPRIVAN)
The participant will receive an intravenous infusion of propofol (DIPRIVAN Injectable Emulsion USP 1%, AstraZeneca).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Asymmetry in feedback vs. feedforward network connectivity
Time Frame: 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.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Presence of P300 and N400 event-related potentials
Time Frame: 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.
|
3 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
January 8, 2016
First Submitted That Met QC Criteria
January 14, 2016
First Posted (Estimate)
January 20, 2016
Study Record Updates
Last Update Posted (Estimate)
October 27, 2016
Last Update Submitted That Met QC Criteria
October 25, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13-784
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Consciousness Disorders
-
Giovanna CristellaNot yet recruitingDisorder of Consciousness
-
First Affiliated Hospital of Zhejiang UniversityCompletedDisorder of ConsciousnessChina
-
University of LiegeUnknown
-
First Affiliated Hospital of Zhejiang UniversityCompletedDisorder of ConsciousnessChina
-
First Affiliated Hospital of Zhejiang UniversityRecruitingDisorders of ConsciousnessChina
-
Xuanwu Hospital, BeijingJilin University; Tianjin UniversityEnrolling by invitationDisorder of ConsciousnessChina
-
First Affiliated Hospital of Zhejiang UniversityUnknownDisorder of ConsciousnessChina
-
I.R.C.C.S. Fondazione Santa LuciaRecruitingDisorder of ConsciousnessItaly
-
University of LiegeCentre Hospitalier Neurologique William Lennox (Belgium); Hôpital Valdor -... and other collaboratorsRecruiting
Clinical Trials on EEG recording
-
Centre d'Investigation Clinique et Technologique...National Research Agency, FranceCompletedAttitude to ComputersFrance
-
Hadassah Medical OrganizationUnknownDepression | Epilepsy | Alzheimer's Disease | Personality Disorder | NeurodegenerationIsrael
-
Mentis CuraThe Icelandic Center for ResearchCompletedStability of EEG Features in Humans
-
Moens MaartenCompletedFailed Back Surgery SyndromeBelgium
-
PainQx, IncUnited States Department of DefenseCompleted
-
Centre Hospitalier Universitaire, AmiensCompleted
-
University Hospital, GrenobleRecruitingParkinson DiseaseFrance
-
Karl Landsteiner Institute for Clinical Epilepsy...AIT Austrian Institute of Technology GmbH; Brainhero GmbHRecruiting