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

NCT03023657 | Terminated

• 2 other identifiers: 16081772016-A01973-48
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 2

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.

Conditions

Consciousness Disorder

Keywords

arousal; Consciousness Disorders; vegetative state; minimally conscious state

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Severe brain-damaged patient in coma awakening

EXPERIMENTAL

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

Interventions

Detection of arousal OTHER

Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury

Severe brain-damaged patient in coma awakening

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medically unstable patient

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (2)

Chu Saint-Etienne

Saint-Etienne, 42055, France

Location

Clinique Mutualiste Saint Etienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Consciousness Disorders; Persistent Vegetative State

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Unconsciousness

Study Officials

• Pascal GIRAUX, MDPhD

  CHU SAINT-ETIENNE

  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: January 13, 2017
• First Posted: January 18, 2017
• Study Start: June 23, 2017
• Primary Completion: October 16, 2017
• Study Completion: October 16, 2017
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)