Clinical trial NCT03706170: Emotion Assessment to Study Consciousness in Awakening Patients
Official title: Emotion Assessment to Study Consciousness in Awakening Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Vegetative State
Keywords: Persistent Vegetative State
minimally conscious state
Emotions
Awareness
electrodermal activity
Electroencephalography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2018-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: electrodermal response
timeFrame: at Day 1
Secondary outcomes:
measure: pupillary response
timeFrame: at Day 1
measure: heart rate modification
timeFrame: at day 1
measure: Variation of the intensity of different Event Related Potentials
timeFrame: at Day 2
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: Jacques LUAUTE, MD
role: PRINCIPAL_INVESTIGATOR
References: