Salivary Biomarkers for Concussion (NCT06149351) | Clinical Trial Compass
RecruitingNot Applicable
Salivary Biomarkers for Concussion
France80 participantsStarted 2023-12-12
Plain-language summary
Concussion (CC) (also called mild head trauma), which accounts for 85% of all head injuries, is very common in professional and amateur athletes. CC is an injury to the brain resulting from the direct or indirect impact of external mechanical forces, momentarily disrupting its function on a cellular level. Unlike more serious head injury (moderate and severe), which can be diagnosed using neuroimaging techniques (CT, MRI, etc.), patients suffering from CC do not necessarily show visible signs of structural abnormalities. As a result, diagnosis of CC is offen difficult.
Recently, several salivary biomarkers (proteins and nucleic acids) of sport related concussion have been identified in professional athletes. However, their reference values have not been determined with sufficient robustness to enable their employment in concussion diagnostic tests.
Who can participate
Age range
18 Years – 50 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 participants aged between 18 and 50 years old.
* Participants willing to comply with the study procedures.
* Participants capable of understanding the purpose, nature, and methodology of the study.
* Participants affiliated to a French social security system or beneficiaries of such a system.
* Participants who have signed the non-opposition form to participate in the research.
Non-inclusion Criteria:
* Participant not affiliated to a French social security system or not a beneficiary of such a system.
* Participants deprived of liberty, protected adults, vulnerable individuals, or minors.
* Participants with a proven or suspected chronic infectious disease that may introduce a risk of contamination during sample handling (laboratories not equipped to handle this type of sample).
* Refusal to sign the non-opposition form to participate in the research.
Non-inclusion specific criteria
* Subject who has had a recent stroke or epilepsy event (within the past 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.
What they're measuring
1
Evaluate the baseline level of salivary molecular biomarkers
Timeframe: 3 years
2
Evaluate the baseline level of salivary molecular biomarkers