Pilot Study on the Correlation Between Accelerations Experienced
ConditionSport Related Concussion
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age19-20
SponsorSys2Diag
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.
Treatment groups
66 Participants
are divided into 1 treatment groupSponsors and collaborators
Sys2Diag
Lead sponsor
Centre National de la Recherche Scientifique, France
Collaborator
Source ClinicalTrials.gov