Brain Network Disruptions Related to Traumatic Coma (NCT03482115) | Clinical Trial Compass
CompletedNot Applicable
Brain Network Disruptions Related to Traumatic Coma
France59 participantsStarted 2018-03-07
Plain-language summary
To provide a fine-grained description of the brain network dysfunctions induced by severe traumatic brain injury (TBI) or anoxic encephalopathy, that are responsible for the acute state of unarousable unawareness, named coma, this trial wants to explore the usefulness in this setting of a combined neuroimaging approaches encompassing several up-to-date techniques as structural MRI, fMRI and positron emission tomography (PET) scan (neuroinflammation ligands).
Who can participate
Age range
18 Years – 75 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 for patients:
* Male or female / age between 18 to 75 years.
* Coma of traumatic or anoxic aetiology (GCS \< 10).
* Early (\< 1 month after TBI) and after the complete withdrawal of sedative agents.
* Written agreement for participation (legal responsible).
Inclusion criteria for controls:
* Male or female / age between 18 to 75 years, paired with patients (gender and age).
* Written agreement for participation
Exclusion criteria:
* Patients without public insurance regime.
* Pregnancy.
* Specific contraindication to the use of MRI (metallic material) or PET (specific allergy related to the ligand).
Exclusion criteria for controls:
\- pharmacological treatments which could interfere with consciousness (left to the judgement of the investigator)
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.
1This trial is focused on traumatic coma and uses PET brain imaging to study network disruptions — can you explain what PET imaging involves and whether the findings from this type of research could ever influence how my loved one's condition is monitored or treated?
2Since this trial has already been completed, have any results been published or shared, and if so, what did the PET imaging data reveal about how brain networks are disrupted in traumatic coma?
3This study is listed as Phase NA, which suggests it's observational or diagnostic rather than testing a new treatment — does that mean participation wouldn't have involved any experimental therapy, and how does that distinction matter when thinking about care options?
4Given that this trial measured neuroimaging data specifically through PET scans, are there similar imaging studies still recruiting that might be relevant to consider, or are there standard diagnostic tools already being used that capture the same kind of brain network information?
5Could the findings from this completed study on brain network disruptions in traumatic coma change any recommendations for rehabilitation or recovery planning, and is it worth seeking out a specialist center that is actively using this type of research in their clinical approach?
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
Matrix of the neuroimaging data in PET examination
Timeframe: First Visit, within three days after day 0