ComatoseEXPRESONREANCT04798508
EXPRE-SON-REA : Expressive Own Names in Neurophysiologic Assessment of Comatose Patients
A study testing Evoked related potential - P3 paradigm in people with Comatose and Neurophysiologic Abnormality, run by Centre Hospitalier St Anne at 1 site in France.
Trial summary
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units. Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Comatose, Neurophysiologic Abnormality
- What is being tested?
- Evoked related potential - P3 paradigm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jul 2020to 30 Oct 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Disorder of consciousness defined as :
- Glasgow coma scale < 8 or >8 but
- eyes opening to pain only
- No response to basic command
- Available neuro-imagery (CT-scan or MRI)
Show all 9Show fewer
- Normal temperature (no fever or hypothermia)
- Normal blood pressure during neurophysiologic evaluation
- Given consent from relatives
Who cannot join
- Brain death
- Known deafness
- Severe sepsis uncontrolled during neurophysiologic evaluation
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
GHU Paris Psychiatrie Neurosciences
Paris, 75014
Estelle Pruvost-Robieux, MD, +33 1 45 65 81 89, e.pruvost@ghu-paris.fr
About this study
Official title: EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.
Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.
Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.
Read the detailed description
Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient. However the correlation of this P3 wave and neurologic prognosis is still imperfect and depends on the etiology of the DOC.
In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices involves more widespread brain areas than neutral voices processing.
Here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. The investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.
- Conditions
- Comatose, Neurophysiologic Abnormality
- Being tested
- Evoked related potential - P3 paradigm
- Keywords
- DOC patients, ERP (Event related Potentials), Consciousness
- Medical subject headings
- Coma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoked related potential - P3 paradigmOther
Evoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice
| Study group | Role | What they receive |
|---|---|---|
| Whole group | Other | The whole group listen successively the 3 paradigms :
* P3 own-name recorded by listening to a smiling voice
* P3 own-name recorded by listening to a neutral voice
* P3 own-name recorded by listening to a rough voice Receives: Other: Evoked related potential - P3 paradigm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months
Determination of the positive predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Measured: 3 months from DOC evaluation
Negative predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Determination of the negative predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Measured: 3 months from DOC evaluation
Sensitivity of P3a responses occurences to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Determination of the sensibility of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Measured: 3 months from DOC evaluation
Specificity of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Determination of the specificity of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Measured: 3 months from DOC evaluation
Secondary outcomes (10)
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Determination of the negative predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
Measured: 7, 14 and 28 days from DOC evaluation
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Determination of the positive predictive value of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
Measured: 7, 14 and 28 days from DOC evaluation
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
Determination of the sensibility of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
Measured: 7, 14 and 28 days from DOC evaluation
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Determination of the specificity of P3a waves (present or absent) for neuroprognostic at 7 days, 14 days and 28 days (according to the CRS-r scale)
Measured: 7, 14 and 28 days from DOC evaluation
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Determination of the negative predictive value of P3a waves (present or absent) for eyes-opening at 3 months
Measured: 3 months
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Determination of the positive predictive value of P3a waves (present or absent) for eyes-opening at 3 months
Measured: 3 months
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
Determination of the sensibility of P3a waves (present or absent) for eyes-opening at 3 months
Measured: 3 months
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Determination of the specificity of P3a waves (present or absent) for eyes-opening at 3 months
Measured: 3 months
Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Amplitudes of P3a waves recorded with own name uttered by expressive and neutral voices
Measured: 3 months
Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Latencies of P3a waves recorded with own name uttered by expressive and neutral voices
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2021
- Study start30 Jul 2020
- Primary completion30 Jul 2022 (estimated)
- Study completion30 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComatoseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier St AnneThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Open and prospective study. Evoked related potentials are recorded for each participant while they listen 3 paradigms successively and in a random order: i) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier St Anne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04798508
- Sponsor's protocol ID
- 2020-A00747-32
- Acronym
- EXPRESONREA
- Status last verified
- Jan 2021
- First submitted
- 5 Mar 2021
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXPRE-SON-REA : Expressive Versus Neutral Own Names in Neurophysiologic Prognosis Assessment of Intensive Care Unit Comatose Patients.
- ClinicalTrials.gov ID
- NCT04798508
- Acronym / sponsor ID
- EXPRESONREA / 2020-A00747-32
- Conditions
- Comatose, Neurophysiologic Abnormality
- Keywords
- DOC patients, ERP (Event related Potentials), Consciousness
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Centre Hospitalier St AnneUniversity, hospital or other
- Study start
- 30 Jul 2020 (actual)
- Primary completion
- 30 Jul 2022 (estimated)
- Study completion
- 30 Oct 2022 (estimated)
- First posted
- 15 Mar 2021 (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.
Evaluating the neurologic prognosis in disorders of consciousness (DOC) patients is still a crucial issue in intensive care units.
Neurophysiology allows the investigators to record cerebral responses of patients to auditory stimuli and in particularly to their own name. Numerous studies try to improve the relevance of the auditory stimuli used in this paradigm.
Here the investigators assess if the use of own name stimuli uttered by more expressive voices (for example smiling voices) modulates the cerebral responses recorded. They then correlate these cerebral responses to the neurologic prognosis at three months.
Detailed description
Late auditory evoked potentials (as P3 wave) are used in neurophysiology to assess the level of consciousness in DOC (disorder of consciousness) patients. The P3 wave, elicited by listening standard and deviant stimuli, corresponds to the activation of a frontoparietal network and is considered to reflect a cognitive attention task. Using the own name of the patient as deviant stimuli improve the ability to detect the P3 wave because of the particularly relevance of this stimulus for the patient. However the correlation of this P3 wave and neurologic prognosis is still imperfect and depends on the etiology of the DOC.
In human cognition, to identify the expressivity valence of a voice is essential. Neural processing of expressive voices involves more widespread brain areas than neutral voices processing.
Here the investigators assume that using own name stimuli uttered by more expressive voices (positive : smiling voice or negative : rough voice) should recruit more widespread brain areas and modulate the cerebral responses recorded. The investigators then evaluate if these cerebral responses are relevant markers of consciousness and correlate them to neurologic prognosis at three months.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open and prospective study. Evoked related potentials are recorded for each participant while they listen 3 paradigms successively and in a random order: i) their own name uttered by a smiling voice ii) their own name uttered by a neutral voice iii) their own name uttered by a rough voice
| Arm | Type | Receives |
|---|---|---|
| Whole group | Other | Other: Evoked related potential - P3 paradigmThe whole group listen successively the 3 paradigms : * P3 own-name recorded by listening to a smiling voice * P3 own-name recorded by listening to a neutral voice * P3 own-name recorded by listening to a rough voice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age over 18
- Disorder of consciousness defined as :
- Glasgow coma scale < 8 or >8 but
- eyes opening to pain only
- No response to basic command
Key exclusion criteria (3 listed)
- Brain death
- Known deafness
- Severe sepsis uncontrolled during neurophysiologic evaluation
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 |
|---|---|---|
| Evoked related potential - P3 paradigmEvoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice | Other | Whole group |
Primary outcome
Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months
Time frame: 3 months from DOC evaluation
Determination of the positive predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Negative predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Time frame: 3 months from DOC evaluation
Determination of the negative predictive values of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Sensitivity of P3a responses occurences to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Time frame: 3 months from DOC evaluation
Determination of the sensibility of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
Specificity of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices at 3 months for the neuroprognosis at 3 months
Time frame: 3 months from DOC evaluation
Determination of the specificity of the occurence of the P3a wave recorded with expressive and neutral voices for neuroprognostic assessment at 3 months (according to the GOS-E scale)
10 secondary outcomes
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Time frame: 7, 14 and 28 days from DOC evaluation
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Time frame: 7, 14 and 28 days from DOC evaluation
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to the CRS-r scale
Time frame: 7, 14 and 28 days from DOC evaluation
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to the CRS-r scale
Time frame: 7, 14 and 28 days from DOC evaluation
Negative predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Time frame: 3 months
Positive predictive value of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Time frame: 3 months
Sensitivity of P3a responses occurences uttered by expressive voices and neutral voices according to eyes-opening
Time frame: 3 months
Specificity of P3a to own-name uttered by expressive voices and neutral voices according to eyes-opening
Time frame: 3 months
Description of the amplitudes of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Time frame: 3 months
Description of the latencies of the P3a wave to own-name uttered by expressive voices versus neutral voices.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evoked related potential - P3 paradigm in people with Comatose and Neurophysiologic Abnormality, run by Centre Hospitalier St Anne 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 9 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Estelle Pruvost-Robieux, MD (+ 33 1 45 65 81 89, e.pruvost@ghu-paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive values of P3a responses to own-names uttered by expressive voices (smiling and rough voices) and neutral voices for the neuroprognosis at 3 months (time frame: 3 months from DOC evaluation). The study lists 4 primary outcomes in all. 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 17 Mar 2021.