Emotion Assessment to Study Consciousness in Awakening Patients

Not Applicable

Completed

• Conditions: Persistent Vegetative State
• Interventions: Behavioral: Physiological recording in response to different types of stimuli; Behavioral: EEG recording in response to different types of stimuli

• Registration Number: NCT03706170
• Lead Sponsor: Hospices Civils de Lyon

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-10-08
• Study First Submitted QC: 2018-10-12
• Study First Posted: 2018-10-15
• Study Start: 2019-02-01
• Primary Completion: 2021-09-29
• Study Completion: 2021-09-29
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acquired Brain damaged patients without DOC	Physiological recording in response to different types of stimuli	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
Healthy subjects	EEG recording in response to different types of stimuli	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.
Vegetative State	Physiological recording in response to different types of stimuli	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.
Minimally Conscious State	Physiological recording in response to different types of stimuli	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.
Vegetative State	EEG recording in response to different types of stimuli	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.
Minimally Conscious State	EEG recording in response to different types of stimuli	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.
Acquired Brain damaged patients without DOC	EEG recording in response to different types of stimuli	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
Healthy subjects	Physiological recording in response to different types of stimuli	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.

Primary Outcome Measures

Name	Time	Method
electrodermal response	at Day 1	skin conductance response measured with trans-cutaneus electrodes

Secondary Outcome Measures

Name	Time	Method
pupillary response	at Day 1	use of eye-tracker
heart rate modification	at day 1	use of transcutaneous electrode
Variation of the intensity of different Event Related Potentials	at Day 2	electroencephalography (EEG) The investigator will study how the intensity of different Event Related Potentials varies with different levels of sound around the auditory threshold: this will be assessed specifically for early cortical components of the auditory response such as the N1 around 100 ms after the stimulus, and for late components around 300-500 ms after the stimulus, particularly the P300.

Trial Locations

Locations (1)

Hospices Civils de Lyon; 🇫🇷 Bron, France