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

Centre Hospitalier Universitaire de Besancon1 site in 1 country50 target enrollmentJune 17, 2013

ConditionsPost Anoxic Coma

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Post Anoxic Coma
Sponsor: Centre Hospitalier Universitaire de Besancon
Enrollment: 50
Locations: 1
Primary Endpoint: Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography
Status: Terminated
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

June 17, 2013

End Date

July 8, 2020

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Besancon

Responsible Party

Sponsor

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography(19 days after the beginning of coma)