ComaMRI-ComaNCT00577954
Multimodal Resonance Imaging for Outcome Prediction on Coma Patients
An observational study of Coma, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Stroke, traumatic head injury, subarachnoid hemorrhage and cerebral anoxia are main causes of a coma condition implying severe brain damage and thus, poor prognosis. Clinicians are often in need for a tool able to predict the awakening of these patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coma
- What is being tested?
- Multimodal MRI
- Type of treatment
- Surgery or procedure
- How many people
- 417 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2006to Jun 2014
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Traumatic brain injured patients, stroke patients, subarachnoid hemorrhage (SAH) patients and cerebral anoxia patients
Who may be able to join
- Adult affiliated to the social security system
- Hospitalized in neuroICU and requiring artificial ventilation following a severe cranial trauma, an ischemic and/or hemorrhagic cerebrovascular accident and/or a cerebral anoxia
- In coma defined as not answering simple orders at least 7 days after the event
- Receiving an amount of sedatives and not being able to explain the coma
- Having a standardized intracranial pressure (≤ 15 mm Hg) and in absence of severe hemodynamic or respiratory failure so that the MRI does not represent any additional danger
Who cannot join
- Coma of infectious or toxic origin
- Coma explained by sedation
- MRI contraindication (pace maker, medical material not MRI compatible)
- Persistent intracranial hypertension contraindicating the setting in prolonged dorsal decubitus (ICP > 20 mm Hg during more than 10 minutes after positioning on decubitus)
- Severe hemodynamic failure
- Severe respiratory failure
Show all 12Show fewer
- Life threatening extra-cerebral lesions
- Cranial trauma of ballistic origin
- Patient presenting a severe compromise of a major function bringing into play the vital outcome, with invalidity before the accident/event
- Former neurological pathology altering the clinical outcome of the cranial trauma
- Refusal of the family
- Patient protected by the law (under supervision or trusteeship)
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hopitaux de Paris Pitie Salpetriere
Paris, 75013
About this study
Official title: Multimodal Magnetic Resonance (MRI) Development in Comatose Patients for an Algorithm in the Prediction of Consciousness Recovery
Stroke, traumatic head injury, subarachnoid hemorrhage and cerebral anoxia are main causes of a coma condition implying severe brain damage and thus, poor prognosis. Clinicians are often in need for a tool able to predict the awakening of these patients. Multimodal MRI, associating the traditional morphological sequences with spectroscopy-MRI (MRS) and the diffusion tensor imaging, could provide such a prediction.
Read the detailed description
Predicting the awakening of patients in comas is one of the principal stakes of the current neurointensive care unit (neuroICU). Several studies and clinical practice suggest that the multimodal MRI, which associates the traditional morphological sequences (T1, T2*, FLAIR/T2), the spectroscopy-MRI (MRS) and the diffusion tensor imaging, is a tool allowing such a prediction. However, this strategy has not been yet validated. Additionally, currently there is no method of analysis including the 4 different sequences.
Objective: The goal of this study is to develop a composite score able to predict the awakening of coma patients following events such as a severe cranial trauma, ischemic or hemorrhagic cerebrovascular accident and cerebral anoxia. This composite score will be built from the results of the multimodal MRI (quantified indicator) in combination with clinical covariables (e.g., age of the patient, the mechanism of the accident (high versus low speed), etc.). The final score will aim to predict the outcome of patients at 1 year, evaluated by one of the following categories: favourable (Glasgow Outcome Scale (GOS 3+, 4, and 5) or unfavourable outcome (GOS 1, 2, and 3). GOS 3- score has been defined as minimally conscious state and GOS 3+ score as severe disability excluding cognitive sequelae.
MRI Analysis: The lesions present on the MRI will be quantified by a neuroradiologist and a dedicated clinical engineer from the coordination centre (Pitié-Salpêtrière Hospital) in a blinded way regarding patients' clinical data. Lesion load-indicators will be calculated on the sequences of FLAIR/T2, T2*, MRS and diffusion tensor imaging from a predefined analysis grid allowing the regional study of the lesions as well as the appreciation of their nature, their uni- or bilateral character and if bilateral, their symmetry.
Hypothesis and applicability: The multivariate analysis of morphological MRI, MRS and diffusion tensor imaging data, combined with the clinical covariables, will aim to develop a statistical algorithm, able to predict the clinical outcome of the patients. In the long term, it will be integrated into an expert system which will be the subject of a patent submission. The final objective is to provide the clinicians a diagnostic tool able to determine outcome of patients with severe cranial trauma and other neurological conditions such as stroke, subarachnoid hemorrhage and cerebral anoxia.
- Conditions
- Coma
- Being tested
- Multimodal MRI
- Keywords
- Coma, TBI, Stroke, SAH, Cerebral Anoxia, Multimodal MRI
- Medical subject headings
- Coma, Stroke, Hypoxia, Brain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal MRIProcedure or surgery
Multimodal MRI
| Study group | Role | What they receive |
|---|---|---|
| 1 | Patients in a coma condition after a traumatic brain injury (250), stroke, cerebral anoxia or subarachnoid hemorrhage (150), for at least 7 days. Receives: Procedure: Multimodal MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
To define a quantified indicator resulting from the analysis of the multimodal MRI combined with clinical data to create a score to predict the 1 year outcome as measured by the dichotomized Glasgow Outcome Scale (extended version [GOSE]).
Measured: one year
Secondary outcomes (2)
Relevance of the composite score to predict the clinical outcome at 1 year assessed by the Rankin score, the GOSE and the disability rating scale (DRS).
Measured: one year
Intra and inter-observer reproducibility study of the analysis of the various sequences.
Measured: during the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2007 (estimated)
- Study startOct 2006
- Primary completionMar 2010
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ComaStudies 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
- Prospective
- Enrolment
- 417 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pr Louis Puybasset,, MD, PhD, Principal investigator, Assistance Publique Hopitaux de Paris Pitié Salpetriere
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00577954
- Sponsor's protocol ID
- P051061
- Acronym
- MRI-Coma
- Status last verified
- Dec 2008
- First submitted
- 19 Dec 2007
- Last updated
- 21 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Puybasset L, Perlbarg V, Unrug J, Cassereau D, Galanaud D, Torkomian G, Battisti V, Lefort M, Velly L, Degos V, Citerio G, Bayen E, Pelegrini-Issac M; MRI-COMA Investigators CENTER-TBI MRI Participants and MRI Only Investigators. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Feb;48(2):201-212. doi: 10.1007/s00134-021-06583-z. Epub 2022 Dec 14.
PubMed 34904191Simeone P, Auzias G, Lefevre J, Takerkart S, Coulon O, Lesimple B, Torkomian G, Battisti V, Jacquens A, Couret D, Naccache L, Bayen E, Bruder N, Perlbarg V, Puybasset L, Velly L. Long-term follow-up of neurodegenerative phenomenon in severe traumatic brain injury using MRI. Ann Phys Rehabil Med. 2022 Nov;65(6):101599. doi: 10.1016/j.rehab.2021.101599. Epub 2022 Feb 15.
PubMed 34718191Velly L, Perlbarg V, Boulier T, Adam N, Delphine S, Luyt CE, Battisti V, Torkomian G, Arbelot C, Chabanne R, Jean B, Di Perri C, Laureys S, Citerio G, Vargiolu A, Rohaut B, Bruder N, Girard N, Silva S, Cottenceau V, Tourdias T, Coulon O, Riou B, Naccache L, Gupta R, Benali H, Galanaud D, Puybasset L; MRI-COMA Investigators. Use of brain diffusion tensor imaging for the prediction of long-term neurological outcomes in patients after cardiac arrest: a multicentre, international, prospective, observational, cohort study. Lancet Neurol. 2018 Apr;17(4):317-326. doi: 10.1016/S1474-4422(18)30027-9. Epub 2018 Feb 27.
PubMed 29500154Luyt CE, Galanaud D, Perlbarg V, Vanhaudenhuyse A, Stevens RD, Gupta R, Besancenot H, Krainik A, Audibert G, Combes A, Chastre J, Benali H, Laureys S, Puybasset L; Neuro Imaging for Coma Emergence and Recovery Consortium. Diffusion tensor imaging to predict long-term outcome after cardiac arrest: a bicentric pilot study. Anesthesiology. 2012 Dec;117(6):1311-21. doi: 10.1097/ALN.0b013e318275148c.
PubMed 23135257
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Magnetic Resonance (MRI) Development in Comatose Patients for an Algorithm in the Prediction of Consciousness Recovery
- ClinicalTrials.gov ID
- NCT00577954
- Acronym / sponsor ID
- MRI-Coma / P051061
- Conditions
- Coma
- Keywords
- Coma, TBI, Stroke, SAH, Cerebral Anoxia, Multimodal MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 417 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Oct 2006
- Primary completion
- Mar 2010 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 20 Dec 2007 (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.
Stroke, traumatic head injury, subarachnoid hemorrhage and cerebral anoxia are main causes of a coma condition implying severe brain damage and thus, poor prognosis. Clinicians are often in need for a tool able to predict the awakening of these patients. Multimodal MRI, associating the traditional morphological sequences with spectroscopy-MRI (MRS) and the diffusion tensor imaging, could provide such a prediction.
Detailed description
Predicting the awakening of patients in comas is one of the principal stakes of the current neurointensive care unit (neuroICU). Several studies and clinical practice suggest that the multimodal MRI, which associates the traditional morphological sequences (T1, T2*, FLAIR/T2), the spectroscopy-MRI (MRS) and the diffusion tensor imaging, is a tool allowing such a prediction. However, this strategy has not been yet validated. Additionally, currently there is no method of analysis including the 4 different sequences.
Objective: The goal of this study is to develop a composite score able to predict the awakening of coma patients following events such as a severe cranial trauma, ischemic or hemorrhagic cerebrovascular accident and cerebral anoxia. This composite score will be built from the results of the multimodal MRI (quantified indicator) in combination with clinical covariables (e.g., age of the patient, the mechanism of the accident (high versus low speed), etc.). The final score will aim to predict the outcome of patients at 1 year, evaluated by one of the following categories: favourable (Glasgow Outcome Scale (GOS 3+, 4, and 5) or unfavourable outcome (GOS 1, 2, and 3). GOS 3- score has been defined as minimally conscious state and GOS 3+ score as severe disability excluding cognitive sequelae.
MRI Analysis: The lesions present on the MRI will be quantified by a neuroradiologist and a dedicated clinical engineer from the coordination centre (Pitié-Salpêtrière Hospital) in a blinded way regarding patients' clinical data. Lesion load-indicators will be calculated on the sequences of FLAIR/T2, T2*, MRS and diffusion tensor imaging from a predefined analysis grid allowing the regional study of the lesions as well as the appreciation of their nature, their uni- or bilateral character and if bilateral, their symmetry.
Hypothesis and applicability: The multivariate analysis of morphological MRI, MRS and diffusion tensor imaging data, combined with the clinical covariables, will aim to develop a statistical algorithm, able to predict the clinical outcome of the patients. In the long term, it will be integrated into an expert system which will be the subject of a patent submission. The final objective is to provide the clinicians a diagnostic tool able to determine outcome of patients with severe cranial trauma and other neurological conditions such as stroke, subarachnoid hemorrhage and cerebral anoxia.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Procedure: Multimodal MRIPatients in a coma condition after a traumatic brain injury (250), stroke, cerebral anoxia or subarachnoid hemorrhage (150), for at least 7 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Traumatic brain injured patients, stroke patients, subarachnoid hemorrhage (SAH) patients and cerebral anoxia patients
Key inclusion criteria (5 listed)
- Adult affiliated to the social security system
- Hospitalized in neuroICU and requiring artificial ventilation following a severe cranial trauma, an ischemic and/or hemorrhagic cerebrovascular accident and/or a cerebral anoxia
- In coma defined as not answering simple orders at least 7 days after the event
- Receiving an amount of sedatives and not being able to explain the coma
- Having a standardized intracranial pressure (≤ 15 mm Hg) and in absence of severe hemodynamic or respiratory failure so that the MRI does not represent any additional danger
Key exclusion criteria (12 listed)
- Coma of infectious or toxic origin
- Coma explained by sedation
- MRI contraindication (pace maker, medical material not MRI compatible)
- Persistent intracranial hypertension contraindicating the setting in prolonged dorsal decubitus (ICP > 20 mm Hg during more than 10 minutes after positioning on decubitus)
- Severe hemodynamic failure
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 |
|---|---|---|
| Multimodal MRIMultimodal MRI | Procedure or surgery | 1 |
Primary outcome
To define a quantified indicator resulting from the analysis of the multimodal MRI combined with clinical data to create a score to predict the 1 year outcome as measured by the dichotomized Glasgow Outcome Scale (extended version [GOSE]).
Time frame: one year
2 secondary outcomes
Relevance of the composite score to predict the clinical outcome at 1 year assessed by the Rankin score, the GOSE and the disability rating scale (DRS).
Time frame: one year
Intra and inter-observer reproducibility study of the analysis of the various sequences.
Time frame: during the study
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 21 Sep 2017.
- Derived from this study: PubMed 34904191Puybasset L, Perlbarg V, Unrug J, Cassereau D, Galanaud D, Torkomian G, Battisti V, Lefort M, Velly L, Degos V, Citerio G, Bayen E, Pelegrini-Issac M; MRI-COMA Investigators CENTER-TBI MRI Participants and MRI Only Investigators. Prognostic value of global deep white matter DTI metrics for 1-year outcome prediction in ICU traumatic brain injury patients: an MRI-COMA and CENTER-TBI combined study. Intensive Care Med. 2022 Feb;48(2):201-212. doi: 10.1007/s00134-021-06583-z. Epub 2022 Dec 14.
- Derived from this study: PubMed 34718191Simeone P, Auzias G, Lefevre J, Takerkart S, Coulon O, Lesimple B, Torkomian G, Battisti V, Jacquens A, Couret D, Naccache L, Bayen E, Bruder N, Perlbarg V, Puybasset L, Velly L. Long-term follow-up of neurodegenerative phenomenon in severe traumatic brain injury using MRI. Ann Phys Rehabil Med. 2022 Nov;65(6):101599. doi: 10.1016/j.rehab.2021.101599. Epub 2022 Feb 15.
- Derived from this study: PubMed 29500154Velly L, Perlbarg V, Boulier T, Adam N, Delphine S, Luyt CE, Battisti V, Torkomian G, Arbelot C, Chabanne R, Jean B, Di Perri C, Laureys S, Citerio G, Vargiolu A, Rohaut B, Bruder N, Girard N, Silva S, Cottenceau V, Tourdias T, Coulon O, Riou B, Naccache L, Gupta R, Benali H, Galanaud D, Puybasset L; MRI-COMA Investigators. Use of brain diffusion tensor imaging for the prediction of long-term neurological outcomes in patients after cardiac arrest: a multicentre, international, prospective, observational, cohort study. Lancet Neurol. 2018 Apr;17(4):317-326. doi: 10.1016/S1474-4422(18)30027-9. Epub 2018 Feb 27.
- Derived from this study: PubMed 23135257Luyt CE, Galanaud D, Perlbarg V, Vanhaudenhuyse A, Stevens RD, Gupta R, Besancenot H, Krainik A, Audibert G, Combes A, Chastre J, Benali H, Laureys S, Puybasset L; Neuro Imaging for Coma Emergence and Recovery Consortium. Diffusion tensor imaging to predict long-term outcome after cardiac arrest: a bicentric pilot study. Anesthesiology. 2012 Dec;117(6):1311-21. doi: 10.1097/ALN.0b013e318275148c.
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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.
Pr Louis Puybasset,, MD, PhD principal investigator
Assistance Publique Hopitaux de Paris Pitié Salpetriere
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 Coma, 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 5 inclusion and 12 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 21 Sep 2017. 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?
To define a quantified indicator resulting from the analysis of the multimodal MRI combined with clinical data to create a score to predict the 1 year outcome as measured by the dichotomized Glasgow Outcome Scale (extended version [GOSE]). (time frame: one year). 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 NCT00577954, which also lists 4 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 21 Sep 2017.