search
Back to results

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

Primary Purpose

Post Anoxic Coma

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
high-density electroencephalography
Conventional electroencephalography
Sponsored by
Centre Hospitalier Universitaire de Besancon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Post Anoxic Coma focused on measuring electroencephalography (EEG), mismatch negativity (MMN)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHRU Besançon

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

electroencephalography recording

Arm Description

Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography

Full Information

First Posted
October 23, 2015
Last Updated
November 9, 2022
Sponsor
Centre Hospitalier Universitaire de Besancon
search

1. Study Identification

Unique Protocol Identification Number
NCT02588482
Brief Title
Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients
Acronym
COMETIQUE
Official Title
Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Recruitment and feasability issues
Study Start Date
June 17, 2013 (Actual)
Primary Completion Date
July 8, 2020 (Actual)
Study Completion Date
July 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Besancon

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post Anoxic Coma
Keywords
electroencephalography (EEG), mismatch negativity (MMN)

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
electroencephalography recording
Arm Type
Experimental
Arm Description
Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously
Intervention Type
Device
Intervention Name(s)
high-density electroencephalography
Intervention Description
Auditory stimulations during electroencephalography recording
Intervention Type
Device
Intervention Name(s)
Conventional electroencephalography
Intervention Description
Auditory stimulations during electroencephalography recording
Primary Outcome Measure Information:
Title
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Description
mismatch negativity is an electrophysiological response recorded after the presentation of deviant auditory stimulations Recovery is assessed 1 month after the beginning of coma
Time Frame
4 days after the beginning of coma
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thierry Moulin, MD, PhD
Organizational Affiliation
Service de neurologie, CHRU Besançon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHRU Besançon
City
Besancon
State/Province
Franche-Comte
ZIP/Postal Code
25000
Country
France

12. IPD Sharing Statement

Learn more about this trial

Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients

We'll reach out to this number within 24 hrs