Emotion Assessment to Study Consciousness in Awakening Patients

Persistent Vegetative State Clinical Trial

— EmotiCones  

Official title:

Emotion Assessment to Study Consciousness in Awakening Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706170
• Other study ID #: 69HCL18_0622
• Secondary ID: 2018-A02673-52
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: February 1, 2025

Study information

• Verified date: January 2024
• Source: Hospices Civils de Lyon
• Contact: Jacques LUAUTE, MD
• Phone: 478865023
• Email: jacques.luaute[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Persistent Vegetative State

Intervention

Behavioral:
• Physiological recording in response to different types of stimuli
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 ; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence.
• EEG recording in response to different types of stimuli
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 ; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon	Bron

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	electrodermal response	skin conductance response measured with trans-cutaneus electrodes	at Day 1
Secondary	pupillary response	use of eye-tracker	at Day 1
Secondary	heart rate modification	use of transcutaneous electrode	at day 1
Secondary	Variation of the intensity of different Event Related Potentials	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.	at Day 2