Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mil… (NCT04982562) | Clinical Trial Compass
RecruitingNot Applicable
Interest of the 7 Tesla MRI in the Diagnosis of Post-concussion Syndromes Among Patients With Mild Traumatic Brain Injury
France100 participantsStarted 2021-06-26
Plain-language summary
We aimed to conduct a prospective longitudinal interventionnal monocentric study to assess the ability of seven tesla MRI to detect diffuses axonal lesions in patients presenting a post concussional syndrom (PCS) at seven days about a mild traumatic brain injury (MTBI). Our first objective was to evaluate the diagnostic performance of seven tesla MRI runned at seven days after MTBI among patients presenting a PCS.
Who can participate
Age range
20 Years – 72 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:
* Mild traumatic brain injury with glascow included between 13 and 15, with indication of scan
* possibilty of performing an MRI at 7 days
* Patient able to get to MRI at Day 7
* Free consentement to the study
* Any measure of guardianship or curatorship , any link of subordination
Exclusion Criteria:
* Patient does not hospitalized about head trauma
* Inhability to move out for run the seven day MRI
* Contraindication for MRI
* Patient having already consulted the emergency for head trauma requiring imaging
* Patients with psychiatric troubles : bipolarity, panic trouble, depressive trouble, schizophrenia
* Patient already enrolled in the study
* History of brain, tumor or neurosurgery
* Untreated or poorly treated chronic vertigo
* Untreated or poorly treated chronic migraines
* Claustrophobia
* BMI \> 40
* Refusal of consent to take part of the study
* No social welfare or inhability to benefit of it by a third party
* Patients with enhanced protection : minor aged under 18 ; person with freedom restriction by justice decision or administrative ; homeliving in health or social establishment ; adult in legal protection
* Pregnant and nursing women
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
Determine the diagnostic performance of 7 Tesla MRI performed of mild head trauma for the occurrence of post-concussion syndrome (PCS)