Persistent Vegetative StateEmotiConesNCT03706170
Emotion Assessment to Study Consciousness in Awakening Patients
A study testing Physiological recording in response to different types of stimuli and EEG recording in response to different types of stimuli in people with Persistent Vegetative State, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Persistent Vegetative State
- What is being tested?
- Physiological recording in response to different types of stimuli and EEG recording in response to different types of stimuli
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 1 Feb 2019to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- For Healthy participants:
- age between 18 and 80
- participant able to understand instructions and normal hearing
- patient with health insurance
- informed consent signed
Who cannot join
- For Patients :
- non controlled epilepsy
- dysautonomic crisis
- unstable medical state
- pregnancy or breath feeding for women
- Persons under guardianship, curatorship
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Physiological recording in response to different types of stimuli, EEG recording in response to different types of stimuli
- Keywords
- Persistent Vegetative State, minimally conscious state, Emotions, Awareness, electrodermal activity, Electroencephalography
- Medical subject headings
- Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiological recording in response to different types of stimuliBehavioural
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 stimuliBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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 Receives: 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. Receives: Behavioral: Physiological recording in response to different types of stimuli; Behavioral: EEG recording in response to different types of stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
electrodermal response
skin conductance response measured with trans-cutaneus electrodes
Measured: at Day 1
Secondary outcomes (3)
pupillary response
use of eye-tracker
Measured: at Day 1
heart rate modification
use of transcutaneous electrode
Measured: at day 1
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.
Measured: at Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start1 Feb 2019
- Primary completion29 Sep 2021
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Vegetative StateStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques LUAUTE, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706170
- Sponsor's protocol ID
- 69HCL18_0622
- Other IDs
- 2018-A02673-52
- Acronym
- EmotiCones
- Status last verified
- Jan 2025
- First submitted
- 8 Oct 2018
- Last updated
- 6 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emotion Assessment to Study Consciousness in Awakening Patients
- ClinicalTrials.gov ID
- NCT03706170
- Acronym / sponsor ID
- EmotiCones / 69HCL18_0622
- Conditions
- Persistent Vegetative State
- Keywords
- Persistent Vegetative State, minimally conscious state, Emotions, Awareness, electrodermal activity, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Feb 2019 (actual)
- Primary completion
- 29 Sep 2021 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Vegetative State | Experimental | Behavioral: Physiological recording in response to different types of stimuli, Behavioral: EEG recording in response to different types of stimuliFor 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 | Experimental | Behavioral: Physiological recording in response to different types of stimuli, Behavioral: EEG recording in response to different types of stimuliFor 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 | Experimental | Behavioral: Physiological recording in response to different types of stimuli, Behavioral: EEG recording in response to different types of stimuliAcquired 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 | Experimental | Behavioral: Physiological recording in response to different types of stimuli, Behavioral: EEG recording in response to different types of stimuliFor healthy subjects (n=15), three experiments will be performed during 2 days in order to assess emotions and consciousness with physiological variables and electroencephalography. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (10 listed)
- non controlled epilepsy
- dysautonomic crisis
- unstable medical state
- pregnancy or breath feeding for women
- Persons under guardianship, curatorship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physiological recording in response to different types of stimuliIn 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. | Behavioural | Acquired Brain damaged patients without DOC, Healthy subjects, Minimally Conscious State, Vegetative State |
| EEG recording in response to different types of stimuliIn 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. | Behavioural | Acquired Brain damaged patients without DOC, Healthy subjects, Minimally Conscious State, Vegetative State |
Primary outcome
electrodermal response
Time frame: at Day 1
skin conductance response measured with trans-cutaneus electrodes
3 secondary outcomes
pupillary response
Time frame: at Day 1
heart rate modification
Time frame: at day 1
Variation of the intensity of different Event Related Potentials
Time frame: at Day 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Persistent Vegetative State
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques LUAUTE, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiological recording in response to different types of stimuli and EEG recording in response to different types of stimuli in people with Persistent Vegetative State, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
electrodermal response (time frame: at Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2025.