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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne (Other)

Overall Status

Unknown status

CT.gov ID

NCT03023657

Collaborator

(none)

Enrollment

Locations

Arm

32.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Consciousness Disorder	Other: Detection of arousal	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jun 23, 2017

Anticipated Primary Completion Date :

Feb 1, 2020

Anticipated Study Completion Date :

Mar 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

facial micro expression found in at least one patient on one video recording [Every day for a week then once a week for four weeks]
Optical camera and thermal camera

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chu Saint-Etienne	Saint Etienne		France	42055
2	Clinique Mutualiste Saint Etienne	Saint Etienne		France	42100

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Investigators

Principal Investigator: Pascal GIRAUX, MDPhD, CHU SAINT-ETIENNE

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Saint Etienne

ClinicalTrials.gov Identifier:

NCT03023657

Other Study ID Numbers:

1608177
2016-A01973-48

First Posted:

Jan 18, 2017

Last Update Posted:

Jul 26, 2019

Last Verified:

Jul 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne

arousal

Consciousness Disorders

vegetative state

minimally conscious state

Additional relevant MeSH terms:

Consciousness Disorders

Study Results

No Results Posted as of Jul 26, 2019