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

Not Applicable

Terminated

• Conditions: Post Anoxic Coma
• Interventions: Device: high-density electroencephalography; Device: Conventional electroencephalography

• Registration Number: NCT02588482
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

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

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-17
• Study First Submitted: 2015-10-23
• Study First Submitted QC: 2015-10-26
• Study First Posted: 2015-10-27
• Primary Completion: 2020-07-08
• Study Completion: 2020-07-08
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-09
• Last Update Posted: 2022-11-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
electroencephalography recording	Conventional electroencephalography	Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously
electroencephalography recording	high-density electroencephalography	Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously

Primary Outcome Measures

Name	Time	Method
Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography	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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHRU Besançon; 🇫🇷 Besancon, Franche-Comte, France