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

Post Anoxic Coma Clinical Trial

— COMETIQUE  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02588482
• Other study ID #: R/2012/46
• Status: Terminated
• Phase: N/A
• Start date: June 17, 2013
• Est. completion date: July 8, 2020

Study information

• Verified date: November 2022
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: July 8, 2020
• Est. primary completion date: July 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coma
• Post Anoxic Coma

Intervention

Device:
• high-density electroencephalography
Auditory stimulations during electroencephalography recording
• Conventional electroencephalography
Auditory stimulations during electroencephalography recording

Locations

Country	Name	City	State
France	CHRU Besançon	Besancon	Franche-Comte

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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