NCT02588482

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 17, 2013

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 27, 2015

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

7.1 years

First QC Date

October 23, 2015

Last Update Submit

November 9, 2022

Conditions

Post Anoxic Coma

Keywords

electroencephalography (EEG)mismatch negativity (MMN)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • 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

Study Arms (1)

electroencephalography recording

EXPERIMENTAL

Cerebral measurements from high-density and conventional electroencephalography are recorded simultaneously

Device: high-density electroencephalographyDevice: Conventional electroencephalography

Interventions

high-density electroencephalographyDEVICE

Auditory stimulations during electroencephalography recording

electroencephalography recording
Conventional electroencephalographyDEVICE

Auditory stimulations during electroencephalography recording

electroencephalography recording

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • post anoxic coma
  • over 18 years old
  • agreement from families
  • alive 4 days after the beginning of coma

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Besançon

Besançon, Franche-Comte, 25000, France

Location

Study Officials

  • Thierry Moulin, MD, PhD

    Service de neurologie, CHRU Besançon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2015

First Posted

October 27, 2015

Study Start

June 17, 2013

Primary Completion

July 8, 2020

Study Completion

July 8, 2020

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

FR(1)