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Emotion Assessment to Study Consciousness in Awakening Patients

Emotion Assessment to Study Consciousness in Awakening Patients

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03706170
Acronym
EmotiCones
Enrollment
15
Registered
2018-10-15
Start date
2019-02-01
Completion date
2021-09-29
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Persistent Vegetative State

Keywords

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

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).

Interventions

BEHAVIORALPhysiological 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.

BEHAVIORALEEG 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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
electrodermal responseat Day 1skin conductance response measured with trans-cutaneus electrodes

Secondary

MeasureTime frameDescription
pupillary responseat Day 1use of eye-tracker
heart rate modificationat day 1use of transcutaneous electrode
Variation of the intensity of different Event Related Potentialsat Day 2electroencephalography (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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026