Consciousness DisorderM-Neuro-DoCNCT04534777
Multimodal Neuroprognostication in Disorders of Consciousness
An observational study of Consciousness Disorder, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Disorders of consciousness frequently occur at the acute phase of brain injuries. For the most severe cases, consciousness impairment can be prolonged. To optimize the medical plan and the goal of care, it is fundamental to have precise tools to predict chances of recovery of consciousness and potential disability. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Consciousness Disorder
- What is being tested?
- repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 9 Sep 2020to May 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery) or with Brain injuries on CT or MRI
Who may be able to join
- Consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery)
- Brain injuries on CT or MRI (e.g. TBI) (traumatic brain-injured ), anoxia or stroke related lesions, etc…)
- Age between 18 and 80 years
Who cannot join
- Deep sedation (e.g. elevated ICP(intracranial pressure ), refractory status epilepticus)
- Sever known neurodegenerative disease (e.g. Alzheimer disease)
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Pitié Salpétrière
Paris, 75013
Benjamin ROHAUT, MD
About this study
Disorders of consciousness frequently occur at the acute phase of brain injuries. For the most severe cases, consciousness impairment can be prolonged. To optimize the medical plan and the goal of care, it is fundamental to have precise tools to predict chances of recovery of consciousness and potential disability. Currently, multimodal assessment including behavioral, neurophysiological and neuroimaging technics is recommended. However, the respective predictive values of these markers are poorly understood and decision making is challenging when results are contradictory
Read the detailed description
Improved treatment of critically ill patients has resulted in increased patients' survival rates in Intensive Care Units (ICU). This is particularly true for brain injury such as traumatic brain injuries, cerebral hemorrhages or cardiac arrest. While some of these patients regain consciousness after a transient state known as coma, other will develop a prolonged disorder of consciousness (DoC) such as chronic unresponsive wakefulness syndrome (also known as vegetative state) or minimally conscious state, or will remain severely disabled. Consciousness diagnosis and prediction of recovery in DoC currently relies on standardized behavioral assessment and disease-specific markers. However, this strategy may fail to detect covert consciousness due to major sensory and motor deficits. Moreover, the DoC etiology and pathophysiology are heterogenous and most likely result from the combination of factors whose interplay still needs to be clarified. Consciousness detection in DoC is of great importance in term of medical management (e.g., pain management, communication), prognosis (e.g., orientation to adapted rehabilitation center to maximize chance of recovery) and end-of-life discussions (e.g., withholding and/or withdrawing of life support discussion). Furthermore, taking care of these patients can be very stressful due to the high levels of uncertainty associated to their potential of recovery. For all these reasons it is critical to develop personalized diagnosis and prognosis assessment tools that can allow better decisions.
The M-NeuroDoC study will take advantage from the state-of-the-art multimodal assessment ongoing at our institution for both acute and chronic patients in order to improve recovery prediction.
Indeed, our multimodal assessment practice constitutes a great and unique opportunity to better understand the respective diagnostic and prognostic accuracy performances of markers such as behavioral, electrophysiological and neuroimaging that are routinely performed at our institution.
The overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches.
Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
Data of interest will be:
- repeated neurological assessments
- repeated behavioural assessments suing validated tools:
- neurophysiological explorations
- conventional brain imagery (CT, IRM)
- quantitative brain imagery
- functional brain imagery , mental imagery
- Conditions
- Consciousness Disorder
- Being tested
- repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery
- Keywords
- electroencephalography, evoked potentials, functional magnetic resonance imaging, minimally conscious state, positron emission tomography, resting state fMRI (functional magnetic resonance imaging ), transcranial magnetic stimulation, traumatic brain injury, unresponsive wakefulness syndrome, vegetative state, polysomnography
- Medical subject headings
- Consciousness Disorders, Persistent Vegetative State, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
repeated neurological, behavioral assessments and conventional, quantitative and functional brain imageryOther
Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
| Study group | Role | What they receive |
|---|---|---|
| Consciousness disorder patients | The overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches.
Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years. Receives: Other: repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
prognosis accuracy of respective predictive markers of consciousness recovery
Calculation of the value (Chi2 tests, specificity, sensitivity, positive and negative predictive values of each tests and of their combinations to distinguish patients states and outcome (24-month GOS-E ≥ 4 or < 4).
Measured: 24 MONTHS
Secondary outcomes (1)
GOS-E Glasgow outcome scale - Extended
Evolution of GOS-E (Glasgow outcome scale - Extended) scale from category 1 ==> Death to category 8: good recovery upper ==>no current problems related to the brain injury that affect daily life
Measured: 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2020
- Study start9 Sep 2020
- Primary completionMay 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Consciousness DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04534777
- Sponsor's protocol ID
- APHP 200194
- Acronym
- M-Neuro-DoC
- Status last verified
- Feb 2024
- First submitted
- 27 Mar 2020
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
PubMed 16350959Hermann B, Goudard G, Courcoux K, Valente M, Labat S, Despois L, Bourmaleau J, Richard-Gilis L, Faugeras F, Demeret S, Sitt JD, Naccache L, Rohaut B; Pitie-Salpetriere hospital Neuro-ICU. Wisdom of the caregivers: pooling individual subjective reports to diagnose states of consciousness in brain-injured patients, a monocentric prospective study. BMJ Open. 2019 Feb 21;9(2):e026211. doi: 10.1136/bmjopen-2018-026211.
PubMed 30792234Andre-Obadia N, Zyss J, Gavaret M, Lefaucheur JP, Azabou E, Boulogne S, Guerit JM, McGonigal A, Merle P, Mutschler V, Naccache L, Sabourdy C, Trebuchon A, Tyvaert L, Vercueil L, Rohaut B, Delval A. Recommendations for the use of electroencephalography and evoked potentials in comatose patients. Neurophysiol Clin. 2018 Jun;48(3):143-169. doi: 10.1016/j.neucli.2018.05.038. Epub 2018 May 18.
PubMed 29784540Balanca B, Dailler F, Boulogne S, Ritzenthaler T, Gobert F, Rheims S, Andre-Obadia N. Diagnostic accuracy of quantitative EEG to detect delayed cerebral ischemia after subarachnoid hemorrhage: A preliminary study. Clin Neurophysiol. 2018 Sep;129(9):1926-1936. doi: 10.1016/j.clinph.2018.06.013. Epub 2018 Jul 5.
PubMed 30007892Rohaut B, Calligaris C, Hermann B, Perez P, Faugeras F, Raimondo F, King JR, Engemann D, Marois C, Le Guennec L, Di Meglio L, Sangare A, Munoz Musat E, Valente M, Ben Salah A, Demertzi A, Belloli L, Manasova D, Jodaitis L, Habert MO, Lambrecq V, Pyatigorskaya N, Galanaud D, Puybasset L, Weiss N, Demeret S, Lejeune FX, Sitt JD, Naccache L. Multimodal assessment improves neuroprognosis performance in clinically unresponsive critical-care patients with brain injury. Nat Med. 2024 Aug;30(8):2349-2355. doi: 10.1038/s41591-024-03019-1. Epub 2024 May 30.
PubMed 38816609
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Neuroprognostication in Disorders of Consciousness
- ClinicalTrials.gov ID
- NCT04534777
- Acronym / sponsor ID
- M-Neuro-DoC / APHP 200194
- Conditions
- Consciousness Disorder
- Keywords
- electroencephalography, evoked potentials, functional magnetic resonance imaging, minimally conscious state, positron emission tomography, resting state fMRI (functional magnetic resonance imaging ), transcranial magnetic stimulation, traumatic brain injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 9 Sep 2020 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 1 Sep 2020 (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.
Disorders of consciousness frequently occur at the acute phase of brain injuries. For the most severe cases, consciousness impairment can be prolonged. To optimize the medical plan and the goal of care, it is fundamental to have precise tools to predict chances of recovery of consciousness and potential disability. Currently, multimodal assessment including behavioral, neurophysiological and neuroimaging technics is recommended. However, the respective predictive values of these markers are poorly understood and decision making is challenging when results are contradictory
Detailed description
Improved treatment of critically ill patients has resulted in increased patients' survival rates in Intensive Care Units (ICU). This is particularly true for brain injury such as traumatic brain injuries, cerebral hemorrhages or cardiac arrest. While some of these patients regain consciousness after a transient state known as coma, other will develop a prolonged disorder of consciousness (DoC) such as chronic unresponsive wakefulness syndrome (also known as vegetative state) or minimally conscious state, or will remain severely disabled. Consciousness diagnosis and prediction of recovery in DoC currently relies on standardized behavioral assessment and disease-specific markers. However, this strategy may fail to detect covert consciousness due to major sensory and motor deficits. Moreover, the DoC etiology and pathophysiology are heterogenous and most likely result from the combination of factors whose interplay still needs to be clarified. Consciousness detection in DoC is of great importance in term of medical management (e.g., pain management, communication), prognosis (e.g., orientation to adapted rehabilitation center to maximize chance of recovery) and end-of-life discussions (e.g., withholding and/or withdrawing of life support discussion). Furthermore, taking care of these patients can be very stressful due to the high levels of uncertainty associated to their potential of recovery. For all these reasons it is critical to develop personalized diagnosis and prognosis assessment tools that can allow better decisions.
The M-NeuroDoC study will take advantage from the state-of-the-art multimodal assessment ongoing at our institution for both acute and chronic patients in order to improve recovery prediction.
Indeed, our multimodal assessment practice constitutes a great and unique opportunity to better understand the respective diagnostic and prognostic accuracy performances of markers such as behavioral, electrophysiological and neuroimaging that are routinely performed at our institution.
The overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches.
Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
Data of interest will be:
- repeated neurological assessments
- repeated behavioural assessments suing validated tools:
- neurophysiological explorations
- conventional brain imagery (CT, IRM)
- quantitative brain imagery
- functional brain imagery , mental imagery
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consciousness disorder patients | – | Other: repeated neurological, behavioral assessments and conventional, quantitative and functional brain imageryThe overall outcome of this project will allow to draw better single-patient predictions of state, prognosis, and rehabilitation strategies and furthermore, a better understanding the pathophysiological mechanisms behind DoC that could result in groundbreaking new personalized therapeutic approaches. Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery) or with Brain injuries on CT or MRI
Key inclusion criteria (3 listed)
- Consciousness disorder (acute sub-acute or chronic for which our expertise is requested to better characterize the diagnostic and prognosis of recovery)
- Brain injuries on CT or MRI (e.g. TBI) (traumatic brain-injured ), anoxia or stroke related lesions, etc…)
- Age between 18 and 80 years
Key exclusion criteria (3 listed)
- Deep sedation (e.g. elevated ICP(intracranial pressure ), refractory status epilepticus)
- Sever known neurodegenerative disease (e.g. Alzheimer disease)
- Pregnancy
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 |
|---|---|---|
| repeated neurological, behavioral assessments and conventional, quantitative and functional brain imageryBased on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years. | Other | Consciousness disorder patients |
Primary outcome
prognosis accuracy of respective predictive markers of consciousness recovery
Time frame: 24 MONTHS
Calculation of the value (Chi2 tests, specificity, sensitivity, positive and negative predictive values of each tests and of their combinations to distinguish patients states and outcome (24-month GOS-E ≥ 4 or < 4).
1 secondary outcome
GOS-E Glasgow outcome scale - Extended
Time frame: 6, 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2024.
- Background: PubMed 16350959Giacino JT, Kalmar K. Diagnostic and prognostic guidelines for the vegetative and minimally conscious states. Neuropsychol Rehabil. 2005 Jul-Sep;15(3-4):166-74. doi: 10.1080/09602010443000498.
- Background: PubMed 30792234Hermann B, Goudard G, Courcoux K, Valente M, Labat S, Despois L, Bourmaleau J, Richard-Gilis L, Faugeras F, Demeret S, Sitt JD, Naccache L, Rohaut B; Pitie-Salpetriere hospital Neuro-ICU. Wisdom of the caregivers: pooling individual subjective reports to diagnose states of consciousness in brain-injured patients, a monocentric prospective study. BMJ Open. 2019 Feb 21;9(2):e026211. doi: 10.1136/bmjopen-2018-026211.
- Background: PubMed 29784540Andre-Obadia N, Zyss J, Gavaret M, Lefaucheur JP, Azabou E, Boulogne S, Guerit JM, McGonigal A, Merle P, Mutschler V, Naccache L, Sabourdy C, Trebuchon A, Tyvaert L, Vercueil L, Rohaut B, Delval A. Recommendations for the use of electroencephalography and evoked potentials in comatose patients. Neurophysiol Clin. 2018 Jun;48(3):143-169. doi: 10.1016/j.neucli.2018.05.038. Epub 2018 May 18.
- Background: PubMed 30007892Balanca B, Dailler F, Boulogne S, Ritzenthaler T, Gobert F, Rheims S, Andre-Obadia N. Diagnostic accuracy of quantitative EEG to detect delayed cerebral ischemia after subarachnoid hemorrhage: A preliminary study. Clin Neurophysiol. 2018 Sep;129(9):1926-1936. doi: 10.1016/j.clinph.2018.06.013. Epub 2018 Jul 5.
- Derived from this study: PubMed 38816609Rohaut B, Calligaris C, Hermann B, Perez P, Faugeras F, Raimondo F, King JR, Engemann D, Marois C, Le Guennec L, Di Meglio L, Sangare A, Munoz Musat E, Valente M, Ben Salah A, Demertzi A, Belloli L, Manasova D, Jodaitis L, Habert MO, Lambrecq V, Pyatigorskaya N, Galanaud D, Puybasset L, Weiss N, Demeret S, Lejeune FX, Sitt JD, Naccache L. Multimodal assessment improves neuroprognosis performance in clinically unresponsive critical-care patients with brain injury. Nat Med. 2024 Aug;30(8):2349-2355. doi: 10.1038/s41591-024-03019-1. Epub 2024 May 30.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Consciousness Disorder, run by Assistance Publique - Hôpitaux de Paris 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 3 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: looking for participants now, as of the sponsor's last update on 5 Feb 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Benjamin ROHAUT, MD (184827888 ext. +33, benjamin.rohaut@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prognosis accuracy of respective predictive markers of consciousness recovery (time frame: 24 MONTHS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04534777, which also lists 5 linked publications.
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 5 Feb 2024.