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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00577954 |
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.
Condition | Intervention |
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Coma |
Procedure: Multimodal MRI |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Multimodal Magnetic Resonance (MRI) Development in Comatose Patients for an Algorithm in the Prediction of Consciousness Recovery |
Estimated Enrollment: | 400 |
Study Start Date: | October 2006 |
Estimated Study Completion Date: | October 2009 |
Groups/Cohorts | Assigned Interventions |
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1
Patients in a coma condition after a traumatic brain injury (250), stroke, cerebral anoxia or subarachnoid hemorrhage (150), for at least 7 days.
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Procedure: Multimodal MRI
Multimodal MRI
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Traumatic brain injured patients, stroke patients, subarachnoid hemorrhage (SAH) patients and cerebral anoxia patients
Inclusion Criteria:
Exclusion Criteria:
Contact: Pr Louis Puybasset, MD, PhD | +33(0)-142163385 | louis.puybasset@psl.aphp.fr |
France | |
Assistance Publique Hopitaux de Paris Pitie Salpetriere | Recruiting |
Paris, France, 75013 | |
Contact: PrLouis Puybasset, MD, PhD +(33)0-142163385 louis.puybasset@psl.aphp.fr |
Principal Investigator: | Pr Louis Puybasset,, MD, PhD | Assistance Publique Hopitaux de Paris Pitié Salpetriere |
Responsible Party: | Research clinical delegation ( Aurelie GUIMFACK ) |
Study ID Numbers: | P051061 |
Study First Received: | December 19, 2007 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00577954 |
Health Authority: | France: Ministry of Health |
Coma TBI Stroke |
SAH Cerebral Anoxia Multimodal MRI |
Coma Signs and Symptoms Unconsciousness Cerebral Infarction Consciousness Disorders |
Stroke Neurologic Manifestations Neurobehavioral Manifestations Anoxia |
Nervous System Diseases |