Emotion Assessment to Study Consciousness in Awakening Patients

NCT03706170 | Completed

• 2 other identifiers: 69HCL18_06222018-A02673-52
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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).

Conditions

Persistent Vegetative State

Keywords

Persistent Vegetative State; minimally conscious state; Emotions; Awareness; electrodermal activity; Electroencephalography

Outcome Measures

Primary Outcomes (1)

• electrodermal response

  skin conductance response measured with trans-cutaneus electrodes

  at Day 1

Secondary Outcomes (3)

• pupillary response

  at Day 1

• heart rate modification

  at day 1

• Variation of the intensity of different Event Related Potentials

  at Day 2

Study Arms (4)

Vegetative State

EXPERIMENTAL

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.

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

Minimally Conscious State

EXPERIMENTAL

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.

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

Acquired Brain damaged patients without DOC

EXPERIMENTAL

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

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

Healthy subjects

EXPERIMENTAL

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.

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

Interventions

Physiological recording in response to different types of stimuli BEHAVIORAL

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.

Acquired Brain damaged patients without DOC; Healthy subjects; Minimally Conscious State; Vegetative State

EEG recording in response to different types of stimuli BEHAVIORAL

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.

Acquired Brain damaged patients without DOC; Healthy subjects; Minimally Conscious State; Vegetative State

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Persistent Vegetative State

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jacques LUAUTE, MD

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2018
• First Posted: October 15, 2018
• Study Start: February 1, 2019
• Primary Completion: September 29, 2021
• Study Completion: September 29, 2021
• Last Updated: January 6, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)