Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients (COMETIQUE)

November 9, 2022 updated by: Centre Hospitalier Universitaire de Besancon

Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients

The purpose of this study is to measure whether high-density electroencephalography can improve the detection of electrophysiological signs of awareness compared to conventional electroencephalography in post-anoxic comatose patients

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Franche-Comte
      • Besancon, Franche-Comte, France, 25000
        • CHRU Besançon

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • post anoxic coma
  • over 18 years old
  • agreement from families
  • alive 4 days after the beginning of coma

Exclusion Criteria:

  • traumatic coma
  • non-traumatic but not anoxic coma
  • patients with severe comorbidity previous to coma
  • refusal of families to participate to the study
  • contraindication to a high-density electroencephalography exam

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: electroencephalography recording
Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously
Device: high-density electroencephalography
Auditory stimulations during electroencephalography recording
Device: Conventional electroencephalography
Auditory stimulations during electroencephalography recording

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Time Frame: 4 days after the beginning of coma
mismatch negativity is an electrophysiological response recorded after the presentation of deviant auditory stimulations Recovery is assessed 1 month after the beginning of coma
4 days after the beginning of coma

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Time Frame: 7 days after the beginning of coma
7 days after the beginning of coma
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Time Frame: 19 days after the beginning of coma
19 days after the beginning of coma

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Besancon

Investigators

  • Principal Investigator: Thierry Moulin, MD, PhD, Service de neurologie, CHRU Besançon

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 (Actual)

June 17, 2013

Primary Completion (Actual)

July 8, 2020

Study Completion (Actual)

July 8, 2020

Study Registration Dates

First Submitted

October 23, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R/2012/46

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.

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