Comparison Between High-density Electroencephalography and Conventional Electroencephalography for Comatose Patients
Overview
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
Full Title of Study: “Comparison Between High-density Electroencephalography and Conventional Electroencephalography to Diagnose the Presence of Consciousness in Post-anoxic Comatose Patients”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Diagnostic
- Masking: None (Open Label)
- Study Primary Completion Date: July 8, 2020
Interventions
- Device: high-density electroencephalography
- Auditory stimulations during electroencephalography recording
- Device: Conventional electroencephalography
- Auditory stimulations during electroencephalography recording
Arms, Groups and Cohorts
- Experimental: electroencephalography recording
- Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Thierry Moulin, MD, PhD, Principal Investigator, Service de neurologie, CHRU Besançon
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