Pilot Study on the Correlation Between Accelerations Experienced (NCT07507253) | Clinical Trial Compass
RecruitingNot Applicable
Pilot Study on the Correlation Between Accelerations Experienced
France66 participantsStarted 2025-01-22
Plain-language summary
Concussion, or mild traumatic brain injury, accounts for 85% of brain injuries and is common in both professional and amateur sports. It results from kinetic impacts causing a temporary disruption of brain function, often without visible abnormalities on imaging, making diagnosis difficult.
The majority of concussions remain undetected, without specific management. To facilitate detection, the development of reliable salivary BMs is essential, as they offer a non-invasive, rapid, and simple method for early identification of biological changes related to concussions.
Who can participate
Age range
19 Years – 20 Years
Sex
MALE
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:
* Male subject
* Subject aged between 19 and 20 years
* Subject willing to follow the study procedures
* Subject capable of understanding the purpose, nature, and methodology of the study
* Subject affiliated with a French social security scheme or a beneficiary of such a scheme
* Subject who has signed the non-opposition to participation in the research
* Subject who has signed the informed consent for salivary micro-RNA analysis
* Subject selected in the French under-20 rugby team (U20).
Exclusion Criteria:
* Subject not affiliated with a French Social Security scheme or not a beneficiary of such a scheme
* Subject deprived of liberty, protected adults, vulnerable persons, or minors
* Subject with proven or suspected chronic infectious disease that may pose a risk of contamination during sample handling (laboratories not equipped to handle this type of sample)
* Subject suffering from Gougerot-Sjögren syndrome (dry syndrome)
* Refusal to sign the non-opposition
* Refusal to sign the informed consent for salivary micro-RNA analysis.
Specific Non-Inclusion Criteria:
* Subject who has suffered a recent stroke or epileptic event (within the last two months)
* Subject suffering from neurological diseases.
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.