Multimodal Resonance Imaging for Outcome Prediction on Coma Patients (NCT00577954) | Clinical Trial Compass
CompletedNot Applicable
Multimodal Resonance Imaging for Outcome Prediction on Coma Patients
France417 participantsStarted 2006-10
Plain-language 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. Multimodal MRI, associating the traditional morphological sequences with spectroscopy-MRI (MRS) and the diffusion tensor imaging, could provide such a prediction.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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]).