Coma Clinical Trial
— MRI-ComaOfficial title:
Multimodal Magnetic Resonance (MRI) Development in Comatose Patients for an Algorithm in the Prediction of Consciousness Recovery
Verified date | December 2008 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 417 |
Est. completion date | June 2014 |
Est. primary completion date | March 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 - 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) |
Country | Name | City | State |
---|---|---|---|
France | Assistance Publique Hopitaux de Paris Pitie Salpetriere | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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]). | one year | ||
Secondary | 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). | one year | ||
Secondary | Intra and inter-observer reproducibility study of the analysis of the various sequences. | during the study |
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