Status:
UNKNOWN
Development of a Point of Care System for Automated Coma Prognosis
Lead Sponsor:
McMaster University
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Natural Sciences and Engineering Research Council, Canada
Conditions:
Coma
Disorder of Consciousness
Eligibility:
All Genders
18+ years
Brief Summary
Electroencephalogram/event-related potentials (EEG/ERP) data will be collected from 50 participants in coma or other disorder of consciousness (DOC; i.e., Unresponsive Wakefulness Syndrome \[UWS\] or ...
Detailed Description
The Problem: Coma is a state of unconsciousness with a variety of causes. Traditional tests for coma outcome prediction are mainly based on a set of clinical observations (e.g., pupillary constriction...
Eligibility Criteria
Inclusion
- Patients (≥ 18 years of age) primarily admitted to the Intensive Care Units, Neurological Step Down Unit, or Coronary Care Unit at Hamilton General Hospital who are in coma with Glasgow Coma Scale (GCS) score of 3-8, or;
- Patients (≥ 18 years of age) who have other disorders of consciousness, primarily Minimally Conscious State (MCS) or Unresponsive Wakefulness Syndrome (UWS; also known as vegetative state).
Exclusion
- Severe liver failure (i.e., Child-Pugh Class C)
- Severe renal failure (i.e., Urea ≥ 40)
- Previous open-head injury
- Known primary and secondary central nervous system malignancy
- Known hearing impairment
- Previous intracranial pathology requiring neurosurgical interventions in the past 72 hours
- Anyone who is deemed medically unsuitable for this study by the attending intensivists
- Healthy Controls:
- Inclusion:
- ≥ 18 years of age
- no visual, language, learning, or hearing problems
- no history of neurological or psychiatric disorder
- not currently taking any medications that act on the central nervous system, such as antidepressants, anxiolytics, or anti-epileptics
- Exclusion:
- (During the COVID-19 pandemic only)
- ≥ 60 years of age
- have a weakened immune system
- have one or more of the COVID-19 high risk medical conditions, according to the government of Canada website: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/people-high-risk-for-severe-illness-covid-19.html.
Key Trial Info
Start Date :
October 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2023
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT03826407
Start Date
October 1 2019
End Date
December 1 2023
Last Update
February 6 2023
Active Locations (1)
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1
McMaster University Hamilton Health Sciences / Hamilton General Hospital
Hamilton, Ontario, Canada, L8L 2X2