Sport Related ConcussionSportCoNCT06149351
Salivary Biomarkers for Concussion
An observational study of Sport Related Concussion, run by Sys2Diag at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Related Concussion
- What is being tested?
- Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 12 Dec 2023to 12 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: A total of 80 subjects will be recruited: * 30 professional sport subject, playing in the professional team of the Montpellier HandBall club (MHB) or the Montpellier Hérault Rugby (MHR) - BRAS S-P. * 30 leisure sport subjects with moderate physical activity playing in the leisure team of clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) or even to the clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) - BRAS S-L. * 20 occasional sport subjects with low intensity physical activity and whose weekly sports practice is less than 4 hours, excluding contact sports, recruited at Sys2diag, delegation 13 of CNRS or in sports clubs linked to the study - BRAS S-O.
Who may be able to join
- 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:
Show all 13Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Sys2Diag - Umr9005 Cnrs/Alcen
Montpellier, 34184
Franck MOLINA, Phd, +33 (0) 467 047 460, s2d.cpp@sys2diag.cnrs.fr
Wendpouiré A OUEDRAOGO, Msc, +33 (0) 467 047 481, s2d.cpp@sys2diag.cnrs.fr
About this study
Official title: Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes
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.
Read the detailed description
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. It is essentially based on subjective observational criteria and on the determination of the Glasgow Coma Scale (GCS) score, a score of 13 to 15 indicating potential CC. In approximately 15% of cases, symptoms such as momentary loss of consciousness (less than 30 minutes), amnesia lasting less than 24 hours, neurological deficit, or convulsions can be used to make a diagnosis. In the majority of cases, concussion goes undetected and no specific treatment or rehabilitation is put in place.
Recently, certain molecular biomarkers (BMs) of CC in elite athletes have been identified (Di Pietro et al. 2021; McCrea et al. 2020). However, the reference values of these BMs are not determined with sufficient robustness to enable the best use for concussion diagnostic tests.
To detect these biomarkers, it is first necessary to determine their physiological profiles as well as the changes in intensity associated with intense physical efforts during training session and/or matches.
- Conditions
- Sport Related Concussion
- Being tested
- Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion
- Keywords
- Concussion, Biomarkers, Sport
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bio-fluid analysis for the implementation of a diagnostic test for sport related concussionDiagnostic test
Saliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Sub-group S-P | 30 professional athletes whose weekly sport practice is more than 8 hours of contact sport. Receives: Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion | |
| Sub-group S-L | 30 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport. Receives: Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion | |
| Sub-group S-O | 20 control subjects who are occasional sport practitioners, having a low intensity physical activity with weekly practicing time is below 4h, excluding contacted sports. Receives: Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the baseline level of salivary molecular biomarkers
Quantification of salivary small non coding RNA (sncRNA) biomarkers of all study subjects: before, during and after intense or moderate sports practice (training and/or matches).
Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Measured: 3 years
Evaluate the baseline level of salivary molecular biomarkers
Quantification of salivary biomarkers including ubiquitin c-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) proteins of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
Measured: 3 years
Secondary outcomes (6)
Differential analysis of expression signatures of salivary sncRNAs of the three groups
Comparison of expression signatures of salivary sncRNAs among the professional athletes, amateur athletes, and occasional sport practitioners.
Expression level of acid nucleic biomarkers are measured in copies/µL and fold change.
Measured: 3 years
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups
Comparison of expression signatures of salivary UCH-L1, GFAP, NSE proteins among the professional athletes, amateur athletes, and occasional sport practitioners.
Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
Measured: 3 years
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations
Comparison of expression signatures of salivary sncRNAs before, during and after different training sessions (bodybuilding, contact, etc) and matches.
Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Measured: 3 years
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations
Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins before, during and after different training sessions (bodybuilding, contact, etc) and matches.
Measured: 3 years
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season
Comparison of expression signatures of salivary sncRNAs at the beginning, in the middle and by the end of the sports season.
Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Measured: 3 years
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season
Comparison of expression level of salivary UCH-L1, GFAP, NSE proteins at the beginning, in the middle and by the end of the sports season.
Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start12 Dec 2023
- Primary completion12 Jun 2026 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Sport Related ConcussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sys2Diag
- Sponsor type
- Other government
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Principal investigator, Thi Nhu Ngoc VAN, Sys2Diag
- Investigators
- Thi Nhu Ngoc VAN, Phd, Principal investigator, Sys2Diag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06149351
- Sponsor's protocol ID
- 2023-A00188-37
- Other IDs
- 2023-A00188-37
- Acronym
- SportCo
- Status last verified
- Mar 2026
- First submitted
- 16 Nov 2023
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Pietro V, Ragusa M, Davies D, Su Z, Hazeldine J, Lazzarino G, Hill LJ, Crombie N, Foster M, Purrello M, Logan A, Belli A. MicroRNAs as Novel Biomarkers for the Diagnosis and Prognosis of Mild and Severe Traumatic Brain Injury. J Neurotrauma. 2017 Jun 1;34(11):1948-1956. doi: 10.1089/neu.2016.4857. Epub 2017 Apr 10.
PubMed 28279125Di Pietro V, O'Halloran P, Watson CN, Begum G, Acharjee A, Yakoub KM, Bentley C, Davies DJ, Iliceto P, Candilera G, Menon DK, Cross MJ, Stokes KA, Kemp SP, Belli A. Unique diagnostic signatures of concussion in the saliva of male athletes: the Study of Concussion in Rugby Union through MicroRNAs (SCRUM). Br J Sports Med. 2021 Dec;55(24):1395-1404. doi: 10.1136/bjsports-2020-103274. Epub 2021 Mar 23.
PubMed 33757972
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Physiological Profile and Evaluation of the Effect of Intense Physical Exertion Among Professional Athletes
- ClinicalTrials.gov ID
- NCT06149351
- Acronym / sponsor ID
- SportCo / 2023-A00188-37
- Conditions
- Sport Related Concussion
- Keywords
- Concussion, Biomarkers, Sport
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sys2DiagOther government
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 12 Dec 2023 (actual)
- Primary completion
- 12 Jun 2026 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 29 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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. It is essentially based on subjective observational criteria and on the determination of the Glasgow Coma Scale (GCS) score, a score of 13 to 15 indicating potential CC. In approximately 15% of cases, symptoms such as momentary loss of consciousness (less than 30 minutes), amnesia lasting less than 24 hours, neurological deficit, or convulsions can be used to make a diagnosis. In the majority of cases, concussion goes undetected and no specific treatment or rehabilitation is put in place.
Recently, certain molecular biomarkers (BMs) of CC in elite athletes have been identified (Di Pietro et al. 2021; McCrea et al. 2020). However, the reference values of these BMs are not determined with sufficient robustness to enable the best use for concussion diagnostic tests.
To detect these biomarkers, it is first necessary to determine their physiological profiles as well as the changes in intensity associated with intense physical efforts during training session and/or matches.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sub-group S-P | – | Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion30 professional athletes whose weekly sport practice is more than 8 hours of contact sport. |
| Sub-group S-L | – | Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion30 amateur athletes, having moderate physical activity whose weekly sport practice is between 4 and 8 hours of contact sport. |
| Sub-group S-O | – | Diagnostic Test: Bio-fluid analysis for the implementation of a diagnostic test for sport related concussion20 control subjects who are occasional sport practitioners, having a low intensity physical activity with weekly practicing time is below 4h, excluding contacted sports. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 80 subjects will be recruited: * 30 professional sport subject, playing in the professional team of the Montpellier HandBall club (MHB) or the Montpellier Hérault Rugby (MHR) - BRAS S-P. * 30 leisure sport subjects with moderate physical activity playing in the leisure team of clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) or even to the clubs associated with the Montpellier Handball (MHB) or the Rugby Club Méditerranée (RCM) - BRAS S-L. * 20 occasional sport subjects with low intensity physical activity and whose weekly sports practice is less than 4 hours, excluding contact sports, recruited at Sys2diag, delegation 13 of CNRS or in sports clubs linked to the study - BRAS S-O.
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bio-fluid analysis for the implementation of a diagnostic test for sport related concussionSaliva of participants will be sampled for analysis of biomarkers of interest (nucleic acids and proteins). The nucleic acids biomarkers will be quantified by reverse transcription followed by amplification (RT-PCR) and Next Generation Sequencing (NGS) techniques while enzymatic assay methods (ELISA) methods will be used to quantify protein biomarkers. | Diagnostic test | Sub-group S-L, Sub-group S-O, Sub-group S-P |
Primary outcome
Evaluate the baseline level of salivary molecular biomarkers
Time frame: 3 years
Quantification of salivary small non coding RNA (sncRNA) biomarkers of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of acid nucleic biomarkers are measured in copies/µL, number of read and fold change.
Evaluate the baseline level of salivary molecular biomarkers
Time frame: 3 years
Quantification of salivary biomarkers including ubiquitin c-terminal hydrolase L1 (UCH-L1), glial fibrillary acidic protein (GFAP) and neuron-specific enolase (NSE) proteins of all study subjects: before, during and after intense or moderate sports practice (training and/or matches). Expression level of protein biomarkers including UCL-L1, GFAP, NSE are measured in pg/mL.
6 secondary outcomes
Differential analysis of expression signatures of salivary sncRNAs of the three groups
Time frame: 3 years
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups
Time frame: 3 years
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout different sport situations
Time frame: 3 years
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout different sport situations
Time frame: 3 years
Differential analysis of expression signatures of salivary sncRNAs of the three groups throughout the sports season
Time frame: 3 years
Differential analysis of expression level of salivary UCH-L1, GFAP, NSE proteins of the three groups throughout the sports season
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2026.
- Background: PubMed 28279125Di Pietro V, Ragusa M, Davies D, Su Z, Hazeldine J, Lazzarino G, Hill LJ, Crombie N, Foster M, Purrello M, Logan A, Belli A. MicroRNAs as Novel Biomarkers for the Diagnosis and Prognosis of Mild and Severe Traumatic Brain Injury. J Neurotrauma. 2017 Jun 1;34(11):1948-1956. doi: 10.1089/neu.2016.4857. Epub 2017 Apr 10.
- Background: PubMed 33757972Di Pietro V, O'Halloran P, Watson CN, Begum G, Acharjee A, Yakoub KM, Bentley C, Davies DJ, Iliceto P, Candilera G, Menon DK, Cross MJ, Stokes KA, Kemp SP, Belli A. Unique diagnostic signatures of concussion in the saliva of male athletes: the Study of Concussion in Rugby Union through MicroRNAs (SCRUM). Br J Sports Med. 2021 Dec;55(24):1395-1404. doi: 10.1136/bjsports-2020-103274. Epub 2021 Mar 23.
- Individual participant dataSharing planned: No
Related trials for Sport Related Concussion
Recruiting
Ecological Test Standardization for Concussion Assessment in Football Players
Concussion, Brain, Sports-related Concussion
Recruiting
Pro-2-Cool Pivotal Trial II
Concussion, Mild
RecruitingPhase 2
Naturally Produced Cannabinoids for Neuroprotection From Concussion
Healthy
Not yet recruiting
Effect of Vestibular Rehabilitation on Gait, Balance, and Coordination in Post Concussion Combat Athletes
Concussion Post Syndrome, Concussion
Not yet recruiting
Mobile Dual-Task Brain and Balance Intervention for Concussion Recovery
Mild Traumatic Brain Injury (mTBI), Sports-related Concussion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thi Nhu Ngoc VAN, Phd principal investigator
Sys2Diag
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sport Related Concussion, run by Sys2Diag at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wendpouiré A OUEDRAOGO, Msc (+33 (0) 467 047 481, alimata.ouedraogo@sys2diag.cnrs.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the baseline level of salivary molecular biomarkers (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06149351, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2026.