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

NCT ID: NCT03023657

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-23

Study Completion Date

2017-10-16

Brief Summary

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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.

Detailed Description

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Conditions

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Consciousness Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Detection of arousal

Intervention Type OTHER

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

Interventions

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Detection of arousal

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pascal GIRAUX, MDPhD

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Chu Saint-Etienne

Saint-Etienne, , France

Site Status

Clinique Mutualiste Saint Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2016-A01973-48

Identifier Type: OTHER

Identifier Source: secondary_id

1608177

Identifier Type: -

Identifier Source: org_study_id

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