search
Back to results

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

Primary Purpose

Consciousness Disorder

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Detection of arousal
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Consciousness Disorder focused on measuring arousal, Consciousness Disorders, vegetative state, minimally conscious state

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chu Saint-Etienne
  • Clinique Mutualiste Saint Etienne

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Severe brain-damaged patient in coma awakening

Arm Description

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.

Outcomes

Primary Outcome Measures

facial micro expression found in at least one patient on one video recording
Optical camera and thermal camera

Secondary Outcome Measures

Full Information

First Posted
January 13, 2017
Last Updated
September 12, 2022
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
search

1. Study Identification

Unique Protocol Identification Number
NCT03023657
Brief Title
Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
Acronym
DAME
Official Title
Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
difficulties to realize the protocol
Study Start Date
June 23, 2017 (Actual)
Primary Completion Date
October 16, 2017 (Actual)
Study Completion Date
October 16, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Consciousness Disorder
Keywords
arousal, Consciousness Disorders, vegetative state, minimally conscious state

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Severe brain-damaged patient in coma awakening
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Detection of arousal
Intervention Description
Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury
Primary Outcome Measure Information:
Title
facial micro expression found in at least one patient on one video recording
Description
Optical camera and thermal camera
Time Frame
Every day for a week then once a week for four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal GIRAUX, MDPhD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Saint-Etienne
City
Saint Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Clinique Mutualiste Saint Etienne
City
Saint Etienne
ZIP/Postal Code
42100
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs