Consciousness DisorderDAMENCT03023657
Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
A study testing Detection of arousal in people with Consciousness Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Consciousness Disorder
- What is being tested?
- Detection of arousal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jun 2017to 16 Oct 2017
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Brain-damaged patient (stroke, traumatic brain injury, anoxia)
- Disorder of consciousness (CRS-R≤ 10) more than 48h after stopping sedation
- Patient without spontaneous or stimulated facial expressions
Who cannot join
- Medically unstable patient
Trial locations and contacts
2 sites in 1 country.
France2 sites
Chu Saint-Etienne
Saint-Etienne, 42055
Clinique Mutualiste Saint Etienne
Saint-Etienne, 42100
About this study
Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.
- Conditions
- Consciousness Disorder
- Being tested
- Detection of arousal
- Keywords
- arousal, Consciousness Disorders, vegetative state, minimally conscious state
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Detection of arousalOther
Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury
| Study group | Role | What they receive |
|---|---|---|
| Severe brain-damaged patient in coma awakening | Experimental | For each patient, video sessions of the face will be performed during a waking period, until the spontaneous macro-EFE (Emotional Facial Expression) reappears. The video sessions will be done without stimulation or with visual, auditory or tactile stimulation. The sessions will be daily for 7 days then weekly for a maximum duration of 4 weeks. Receives: Other: Detection of arousal |
What is being measured
The primary outcome is the main question the study is designed to answer.
facial micro expression found in at least one patient on one video recording
Optical camera and thermal camera
Measured: Every day for a week then once a week for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study start23 Jun 2017
- Primary completion16 Oct 2017
- Study completion16 Oct 2017
Why it stopped: difficulties to realize the protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consciousness DisorderStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascal GIRAUX, MDPhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03023657
- Sponsor's protocol ID
- 1608177
- Other IDs
- 2016-A01973-48
- Acronym
- DAME
- Status last verified
- Sep 2022
- First submitted
- 13 Jan 2017
- Last updated
- 14 Sep 2022
- 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 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Arousal With Facial Micro-expression in Severe Brain-damaged Patient
- ClinicalTrials.gov ID
- NCT03023657
- Acronym / sponsor ID
- DAME / 1608177
- Conditions
- Consciousness Disorder
- Keywords
- arousal, Consciousness Disorders, vegetative state, minimally conscious state
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties to realize the protocol
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 23 Jun 2017 (actual)
- Primary completion
- 16 Oct 2017 (actual)
- Study completion
- 16 Oct 2017 (actual)
- First posted
- 18 Jan 2017 (estimated)
- 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.
Severe brain injuries lead to disorders of consciousness after coma. During this awakening period, detection of arousal is critical to the adaptation of medical strategy, but global paralysis, including facial expression, make the clinical assessment very difficult. Emotional facial expressions are a significant part of this clinical assessment. They are both a landmark of the internal state of the patient (comfort versus discomfort) and a landmark of the relational level with his environment. Visible emotional facial expression is a large temporal phenomenon lasting a couple of seconds, while a microexpression is barely noticeable and very brief. These micro expressions are usually produced when one tried to voluntary hide emotional expressions. In this study, we hypothesize that some patients awakening from coma could still produce microexpression before being able to produce visible emotional facial expressions. This ability to produce micro-expression could be an early landmark of relational awakening in severe brain lesions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe brain-damaged patient in coma awakening | Experimental | Other: Detection of arousalFor each patient, video sessions of the face will be performed during a waking period, until the spontaneous macro-EFE (Emotional Facial Expression) reappears. The video sessions will be done without stimulation or with visual, auditory or tactile stimulation. The sessions will be daily for 7 days then weekly for a maximum duration of 4 weeks. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Brain-damaged patient (stroke, traumatic brain injury, anoxia)
- Disorder of consciousness (CRS-R≤ 10) more than 48h after stopping sedation
- Patient without spontaneous or stimulated facial expressions
Key exclusion criteria (1 listed)
- Medically unstable patient
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 |
|---|---|---|
| Detection of arousalDetecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury | Other | Severe brain-damaged patient in coma awakening |
Primary outcome
facial micro expression found in at least one patient on one video recording
Time frame: Every day for a week then once a week for four weeks
Optical camera and thermal camera
Results and safety
The study was stopped early (reason given: difficulties to realize the protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Pascal GIRAUX, MDPhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Detection of arousal in people with Consciousness Disorder, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 3 inclusion and 1 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: stopped early, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: difficulties to realize the protocol). Results are not available in the source record.
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?
facial micro expression found in at least one patient on one video recording (time frame: Every day for a week then once a week for four weeks). 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 14 Sep 2022.