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

Consciousness Disorder Clinical Trial

— DAME  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03023657
• Other study ID #: 1608177
• Secondary ID: 2016-A01973-48
• Status: Terminated
• Phase: N/A
• Start date: June 23, 2017
• Est. completion date: October 16, 2017

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: October 16, 2017
• Est. primary completion date: October 16, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Consciousness Disorder
• Consciousness Disorders

Intervention

Other:
• Detection of arousal
Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury

Locations

Country	Name	City	State
France	Chu Saint-Etienne	Saint Etienne
France	Clinique Mutualiste Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	facial micro expression found in at least one patient on one video recording	Optical camera and thermal camera	Every day for a week then once a week for four weeks