Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion (NCT04364568) | Clinical Trial Compass
TerminatedNot Applicable
Minor Traumatic Brain Injury : MRI Examination of Consequences and Social Insertion
Stopped: difficulty recruiting and no sociologists
France11 participantsStarted 2021-07-02
Plain-language summary
Minor traumatic brain injury (mTBI) (Glasgow Coma Scale 13 to 15) represent 70 to 90% of traumatic brain injury. Different disorders may occur after a traumatic minor brain injury (somatic, cognitive or affective) within 2 weeks.
For 10 to 20% these symptoms are persistent and are part of post-concussion syndrome. Today a small amount of tools to predict this syndrome are available. Cerebral CT scan, a routine test for mTBI, isn't relevant to predict the post concussion syndrome.
In order to improve understanding of the evolution toward this complication, it seems relevant to run a multimodal study.
Multiparameter MRI combined to psychological and sociological evaluations cold provide a better global perception.
Who can participate
Age range
18 Years – 65 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:
* Patients who answered to psychological questionnaires 3 month after mTBI
* Patients with mTBI according to European Federation of Neurological Societies
* Initial CT scan indication according to 2012 French Society of Emergency Medicine and European Federation of Neurological Societies
* Health insurance
* Written consent
Exclusion Criteria:
* Under 18 years
* Psychiatric or neurologic history with long term treatment
* Hospitalization due to extra-cranial wounds or intoxication (except alcool)
* MTBI due to aggression
* MRI contraindication
* Inability to understand french language
* Pregnant or breastfeeding women
* Incapacitated patients in accordance with article L 1121-5 to L1121-8 of the public health code
* Patients in another study's exclusion time
* Inability to have a follow-up
* Patients who can't be reached in case of emergency
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
Compare the mean lesion volume fraction found in multiparametric magnetic resonance imaging between patients with and without post-concussions syndrome, three months after a mild Traumatic Brain Injury.