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Development of a Point of Care System for Automated Coma Prognosis

NCT03826407 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2023-02-06

No results posted yet for this study

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 Minimally Conscious State \[MCS\]), clinically diagnosed using the Glasgow Coma Scale (GCS). For coma patients, EEG recordings will be conducted for up to 24 consecutive hours at a maximum of 5 timepoints, spanning 30 days from the date of recruitment, to track participants' clinical state. For DOC patients, there will be an initial EEG recording up to 24 hours, with possible subsequent weekly recordings up to 2 hours. An additional dataset from 40 healthy controls will be collected, each spanning up to a 12-hour recording period in order to formulate a baseline. Collected data are to form the basis for automatic analysis and detection of ERP components in DOC, using a machine learning paradigm. Salient features (i.e., biomarkers) extracted from the ERPs and resting-state EEG will be identified and combined in an optimal fashion to give an accurate indicator of prognosis.

Conditions

  • Coma
  • Disorder of Consciousness
  • Minimally Conscious State
  • Vegetative State
  • Neuropathology

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Natural Sciences and Engineering Research Council, Canada

    collaborator OTHER

  • Hamilton Health Sciences Corporation

    collaborator OTHER

  • Brain Vision Solutions Inc.

    collaborator UNKNOWN

  • McGill University

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • John F Connolly, PhD · McMaster University

  • Alison Fox-Robichaud, MD · Hamilton Health Sciences - Hamilton General site

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-01
Primary Completion
2022-08-12
Completion
2023-12-31

Countries

  • Canada

Study Locations

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Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03826407 on ClinicalTrials.gov