Emotion Assessment to Study Consciousness in Awakening Patients (EmotiCones)

Civil Hospices of Lyon

Status: Completed

Conditions: Persistent Vegetative State

Treatments: Behavioral: Physiological recording in response to different types of stimuli; Behavioral: EEG recording in response to different types of stimuli

Study type: Interventional

Funder types: Other

Identifiers

NCT03706170

2018-A02673-52 (Other Identifier)

69HCL18_0622

Details and patient eligibility

About

After a coma, one important challenge is the detection of awareness with patients with disorders of consciousness. For some patients, the only behavioral manifestation indicative of awareness is an appropriate emotional response. Studies show that the use of a particular conditioning - with delay - appears to be an objective solution to study the conscious perception of an emotion in none-communicating people. Until now, emotions of patients suffering disorder of consciousness (DOC) have been scarcely studied. It has been proved that some awakening patients have vegetative reactions following an emotional stimulus, but the investigator can't confirm whether or not the emotional experience of the patient is conscious.

The investigator's main purpose is to study emotional reactions from patients suffering a disorder of consciousness.

The investigator hypothesize that some patients have preserved reflexes reaction to the emotional stimuli while others could demonstrate a conscious emotional experience.

In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli both in DOC patients and healthy controls; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence. The investigator plan to include patients vegetative patients (n=15); minimally conscious patients (n=15); acquired brain injured patients without conscious disorder (n=15) and healthy participants (n=15).

Enrollment: 15 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

For Patients :

• age between 18 and 80
• acquired brain lesion (brain injury, stroke, anoxia) with a delay since the insult superior to 1 month
• level of consciousness assessed with the coma recovery scale revised (CRS-R)
• patient with health insurance
• informed consent signed by the patients or his representative

For Healthy participants:

• age between 18 and 80
• participant able to understand instructions and normal hearing
• patient with health insurance
• informed consent signed

Exclusion criteria

For Patients :

• non controlled epilepsy
• dysautonomic crisis
• unstable medical state
• pregnancy or breath feeding for women
• Persons under guardianship, curatorship

For Healthy participants:

• neurological disorder
• pregnancy or breath feeding for women
• Persons under guardianship, curatorship or any other administrative or judicial measure of deprivation of rights or liberty

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Vegetative State

Experimental group

Description:

For patients in vegetative state (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.

Treatment:

Behavioral: EEG recording in response to different types of stimuli

Behavioral: Physiological recording in response to different types of stimuli

Minimally Conscious State

Experimental group

Description:

For patients in minimally conscious state (n = 15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.

Treatment:

Behavioral: EEG recording in response to different types of stimuli

Behavioral: Physiological recording in response to different types of stimuli

Acquired Brain damaged patients without DOC

Experimental group

Description:

Acquired Brain damaged patients without disorder of consciousness (patients without DOC) For patients with acquired brain damage without disorder of consciousness (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography

Treatment:

Behavioral: EEG recording in response to different types of stimuli

Behavioral: Physiological recording in response to different types of stimuli

Healthy subjects

Experimental group

Description:

For healthy subjects (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography.

Treatment:

Behavioral: EEG recording in response to different types of stimuli

Behavioral: Physiological recording in response to different types of stimuli