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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