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

Study Overview
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Brief Summary
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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

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

Conditions
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Post Anoxic Coma

Intervention / Treatment
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* Device: high-density electroencephalography
* Device: Conventional electroencephalography


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who recovered and who presented a mismatch negativity in high-density but not conventional electroencephalography |  | 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 |  | 19 days after the beginning of coma | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electroencephalography (EEG), mismatch negativity (MMN)