Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient (DAME)

September 12, 2022 updated by: Centre Hospitalier Universitaire de Saint Etienne
Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint Etienne, France, 42055
        • Chu Saint-Etienne
      • Saint Etienne, France, 42100
        • Clinique Mutualiste Saint Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Brain-damaged patient (stroke, traumatic brain injury, anoxia)
  • Disorder of consciousness (CRS-R≤ 10) more than 48h after stopping sedation
  • Patient without spontaneous or stimulated facial expressions

Exclusion Criteria:

  • Medically unstable patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Severe brain-damaged patient in coma awakening
For each patient, video sessions of the face will be performed during a waking period, until the spontaneous macro-EFE (Emotional Facial Expression) reappears. The video sessions will be done without stimulation or with visual, auditory or tactile stimulation. The sessions will be daily for 7 days then weekly for a maximum duration of 4 weeks.
Other: Detection of arousal
Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
facial micro expression found in at least one patient on one video recording
Time Frame: Every day for a week then once a week for four weeks
Optical camera and thermal camera
Every day for a week then once a week for four weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Pascal GIRAUX, MDPhD, Chu Saint-Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 23, 2017

Primary Completion (ACTUAL)

October 16, 2017

Study Completion (ACTUAL)

October 16, 2017

Study Registration Dates

First Submitted

January 13, 2017

First Submitted That Met QC Criteria

January 13, 2017

First Posted (ESTIMATE)

January 18, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 12, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1608177
  • 2016-A01973-48 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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