Sport Related ConcussionBIOIMPACTNCT07507253
Pilot Study on the Correlation Between Accelerations Experienced
An observational study of Sport Related Concussion, run by Sys2Diag at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sport Related Concussion
- What is being tested?
- Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2025to 21 Jan 2028
- 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 19 to 20 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: A total of 66 subjects will be recruited from the players of the French under-20 rugby team (U20) called up for sporting events such as the Six Nations Tournament or the World Cup. Their saliva will be analysed and the variations in biomarkers of interest will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations.
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 9Show fewer
- Specific Non-Inclusion Criteria:
- Subject who has suffered a recent stroke or epileptic event (within the last two months)
- Subject suffering from neurological diseases.
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: Pilot Study on the Correlation Between Accelerations Experienced During Matches by Professional Rugby Players and a Profile of Salivary Biomarkers Identified in the Literature as Related to Concussion.
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.
Read the detailed description
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. Recently, several molecular biomarkers (BMs) of concussion in high-level athletes have been identified.
However, the physiological reference values of these BMs are not yet sufficiently established to allow optimal use of diagnostic tests for concussion. 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.
It is also crucial to correlate these changes with the physical forces experienced by players during impacts. Indeed, the literature indicates that concussions can result from rapid head movements, often caused by violent linear and angular accelerations/decelerations, even if indirect.
- Conditions
- Sport Related Concussion
- Being tested
- Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.
- Keywords
- Concussion, Biomarkers, Sport, Instrumented mouthguards
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.Diagnostic test
Nucleic acids will be extracted from the participants' saliva using a commercial extraction kit (Qiagen). The miRNAs will then be analyzed by RT-qPCR. The miRNAs will first undergo a reverse transcription step to generate complementary DNAs. Then, using specific primers, the complementary DNAs will be amplified and measured by quantitative PCR (qPCR).
The levels of proteins of interest (NSE, UCHL1, and GFAP) will be measured in the participants' saliva using enzymatic assay methods or ELISA-type methods carried out using commercial kits.
An instrumented mouthguard will measure the intensity (acceleration) and the number of impacts sustained by each player during matches.
| Study group | Role | What they receive |
|---|---|---|
| U20 | The saliva of 66 professional rugby players from the French U20 team will be analysed and the variations in biomarkers of interest (identified as related to concussion) will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations. Receives: Diagnostic Test: Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the intensity and number of impacts
The primary objective is to assess whether the intensity and number of impacts (acceleration forces) sustained by players during high-intensity matches are correlated with a variation in the profiles of salivary biomarkers (proteins and short nucleic acids) described for concussion, which will be measured before and after a match in professional rugby players (U20).
Measured: 3 Years
Secondary outcomes (3)
Measure the concentration of salivary BMs
Measure the concentration of salivary BMs during competitive matches such as the Six Nations Tournament of the French under-20 rugby team (U20) to determine the physiological values of the biomarkers.
Measured: 3 Years
Measure the acceleration and deceleration forces
Measure the acceleration and deceleration forces experienced by players during these matches, as well as their number.
Measured: 3 Years
Compare the profiles of BMs
Compare the profiles of BMs in the saliva of professional sports players before and after each match.
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 posted2 Apr 2026
- Study start22 Jan 2025
- Primary completion21 Jan 2027 (estimated)
- Study completion21 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)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
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sys2Diag
- Sponsor type
- Other government
- Collaborators
- Centre National de la Recherche Scientifique, France
- Responsible party
- Principal investigator, Malik KAHLI, Sys2Diag
- Investigators
- Malik KAHLI, PhD, Principal investigator, Sys2Diag
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507253
- Sponsor's protocol ID
- 2024-A02331-46
- Other IDs
- 24.05325.000379
- Acronym
- BIOIMPACT
- Status last verified
- Apr 2026
- First submitted
- 26 Mar 2026
- Last updated
- 9 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lefevre-Dognin C, Cogne M, Perdrieau V, Granger A, Heslot C, Azouvi P. Definition and epidemiology of mild traumatic brain injury. Neurochirurgie. 2021 May;67(3):218-221. doi: 10.1016/j.neuchi.2020.02.002. Epub 2020 May 6.
PubMed 32387427van Stegeren AH, Wolf OT, Kindt M. Salivary alpha amylase and cortisol responses to different stress tasks: impact of sex. Int J Psychophysiol. 2008 Jul;69(1):33-40. doi: 10.1016/j.ijpsycho.2008.02.008. Epub 2008 Mar 5.
PubMed 18417235Roe G, Sawczuk T, Owen C, Tooby J, Starling L, Gilthorpe MS, Falvey E, Hendricks S, Rasmussen K, Readhead C, Salmon D, Stokes K, Tucker R, Jones B. Head Acceleration Events During Tackle, Ball-Carry, and Ruck Events in Professional Southern Hemisphere Men's Rugby Union Matches: A Study Using Instrumented Mouthguards. Scand J Med Sci Sports. 2024 Jun;34(6):e14676. doi: 10.1111/sms.14676.
PubMed 38867444Tooby J, Till K, Gardner A, Stokes K, Tierney G, Weaving D, Rowson S, Ghajari M, Emery C, Bussey MD, Jones B. When to Pull the Trigger: Conceptual Considerations for Approximating Head Acceleration Events Using Instrumented Mouthguards. Sports Med. 2024 Jun;54(6):1361-1369. doi: 10.1007/s40279-024-02012-5. Epub 2024 Mar 9.
PubMed 38460080Hicks SD, Onks C, Kim RY, Zhen KJ, Loeffert J, Loeffert AC, Olympia RP, Fedorchak G, DeVita S, Rangnekar A, Leddy J, Haider MN, Gagnon Z, McLoughlin CD, Badia M, Randall J, Madeira M, Yengo-Kahn AM, Wenzel J, Heller M, Zwibel H, Roberts A, Johnson S, Monteith C, Dretsch MN, Campbell TR, Mannix R, Neville C, Middleton F. Diagnosing mild traumatic brain injury using saliva RNA compared to cognitive and balance testing. Clin Transl Med. 2020 Oct;10(6):e197. doi: 10.1002/ctm2.197.
PubMed 33135344Woodward J, Tooby J, Tucker R, Falvey EC, Salmon DM, Starling L, Tierney G. Instrumented mouthguards in elite-level men's and women's rugby union: characterising tackle-based head acceleration events. BMJ Open Sport Exerc Med. 2024 Aug 1;10(3):e002013. doi: 10.1136/bmjsem-2024-002013. eCollection 2024.
PubMed 39104376Tooby J, Woodward J, Tucker R, Jones B, Falvey E, Salmon D, Bussey MD, Starling L, Tierney G. Correction to: Instrumented Mouthguards in Elite-Level Men's and Women's Rugby Union: The Incidence and Propensity of Head Acceleration Events in Matches. Sports Med. 2024 May;54(5):1339-1341. doi: 10.1007/s40279-023-01968-0. No abstract available.
PubMed 37938534Daneshvar DH, Nair ES, Baucom ZH, Rasch A, Abdolmohammadi B, Uretsky M, Saltiel N, Shah A, Jarnagin J, Baugh CM, Martin BM, Palmisano JN, Cherry JD, Alvarez VE, Huber BR, Weuve J, Nowinski CJ, Cantu RC, Zafonte RD, Dwyer B, Crary JF, Goldstein LE, Kowall NW, Katz DI, Stern RA, Tripodis Y, Stein TD, McClean MD, Alosco ML, McKee AC, Mez J. Leveraging football accelerometer data to quantify associations between repetitive head impacts and chronic traumatic encephalopathy in males. Nat Commun. 2023 Jun 20;14(1):3470. doi: 10.1038/s41467-023-39183-0.
PubMed 37340004Powell JR, Boltz AJ, DeCicco JP, Chandran A, DeLellis SM, Healy ML, Kane SF, Lynch JH, Means GE, Hackney AC, Mihalik JP. Neuroinflammatory Biomarkers Associated With Mild Traumatic Brain Injury History in Special Operations Forces Combat Soldiers. J Head Trauma Rehabil. 2020 Sep/Oct;35(5):300-307. doi: 10.1097/HTR.0000000000000598.
PubMed 32881763LaRocca D, Barns S, Hicks SD, Brindle A, Williams J, Uhlig R, Johnson P, Neville C, Middleton FA. Comparison of serum and saliva miRNAs for identification and characterization of mTBI in adult mixed martial arts fighters. PLoS One. 2019 Jan 2;14(1):e0207785. doi: 10.1371/journal.pone.0207785. eCollection 2019.
PubMed 30601825Janigro D, Kawata K, Silverman E, Marchi N, Diaz-Arrastia R. Is Salivary S100B a Biomarker of Traumatic Brain Injury? A Pilot Study. Front Neurol. 2020 Jun 12;11:528. doi: 10.3389/fneur.2020.00528. eCollection 2020.
PubMed 32595592Di 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 33757972McCrea M, Broglio SP, McAllister TW, Gill J, Giza CC, Huber DL, Harezlak J, Cameron KL, Houston MN, McGinty G, Jackson JC, Guskiewicz K, Mihalik J, Brooks MA, Duma S, Rowson S, Nelson LD, Pasquina P, Meier TB; CARE Consortium Investigators; Foroud T, Katz BP, Saykin AJ, Campbell DE, Svoboda SJ, Goldman J, DiFiori J. Association of Blood Biomarkers With Acute Sport-Related Concussion in Collegiate Athletes: Findings From the NCAA and Department of Defense CARE Consortium. JAMA Netw Open. 2020 Jan 3;3(1):e1919771. doi: 10.1001/jamanetworkopen.2019.19771.
PubMed 31977061
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Correlation Between Accelerations Experienced During Matches by Professional Rugby Players and a Profile of Salivary Biomarkers Identified in the Literature as Related to Concussion.
- ClinicalTrials.gov ID
- NCT07507253
- Acronym / sponsor ID
- BIOIMPACT / 2024-A02331-46
- Conditions
- Sport Related Concussion
- Keywords
- Concussion, Biomarkers, Sport, Instrumented mouthguards
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Sys2DiagOther government
- Collaborators
- Centre National de la Recherche Scientifique, France
- Study start
- 22 Jan 2025 (actual)
- Primary completion
- 21 Jan 2027 (estimated)
- Study completion
- 21 Jan 2028 (estimated)
- First posted
- 2 Apr 2026 (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, 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.
Detailed description
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. Recently, several molecular biomarkers (BMs) of concussion in high-level athletes have been identified.
However, the physiological reference values of these BMs are not yet sufficiently established to allow optimal use of diagnostic tests for concussion. 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.
It is also crucial to correlate these changes with the physical forces experienced by players during impacts. Indeed, the literature indicates that concussions can result from rapid head movements, often caused by violent linear and angular accelerations/decelerations, even if indirect.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| U20 | – | Diagnostic Test: Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.The saliva of 66 professional rugby players from the French U20 team will be analysed and the variations in biomarkers of interest (identified as related to concussion) will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations. |
Who may qualify
- Ages
- 19 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- A total of 66 subjects will be recruited from the players of the French under-20 rugby team (U20) called up for sporting events such as the Six Nations Tournament or the World Cup. Their saliva will be analysed and the variations in biomarkers of interest will be mesured in order to analyze the correlations of these measurements with those obtained during the same matches by an instrumented mouthguard measuring accelerations.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Analyze correlations between the measurements of the variations in biomarkers with those obtained by an instrumented mouthguard measuring accelerations.Nucleic acids will be extracted from the participants' saliva using a commercial extraction kit (Qiagen). The miRNAs will then be analyzed by RT-qPCR. The miRNAs will first undergo a reverse transcription step to generate complementary DNAs. Then, using specific primers, the complementary DNAs will be amplified and measured by quantitative PCR (qPCR). The levels of proteins of interest (NSE, UCHL1, and GFAP) will be measured in the participants' saliva using enzymatic assay methods or ELISA-type methods carried out using commercial kits. An instrumented mouthguard will measure the intensity (acceleration) and the number of impacts sustained by each player during matches. | Diagnostic test | U20 |
Primary outcome
Assess the intensity and number of impacts
Time frame: 3 Years
The primary objective is to assess whether the intensity and number of impacts (acceleration forces) sustained by players during high-intensity matches are correlated with a variation in the profiles of salivary biomarkers (proteins and short nucleic acids) described for concussion, which will be measured before and after a match in professional rugby players (U20).
3 secondary outcomes
Measure the concentration of salivary BMs
Time frame: 3 Years
Measure the acceleration and deceleration forces
Time frame: 3 Years
Compare the profiles of BMs
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 9 Apr 2026.
- Background: PubMed 32387427Lefevre-Dognin C, Cogne M, Perdrieau V, Granger A, Heslot C, Azouvi P. Definition and epidemiology of mild traumatic brain injury. Neurochirurgie. 2021 May;67(3):218-221. doi: 10.1016/j.neuchi.2020.02.002. Epub 2020 May 6.
- Background: PubMed 18417235van Stegeren AH, Wolf OT, Kindt M. Salivary alpha amylase and cortisol responses to different stress tasks: impact of sex. Int J Psychophysiol. 2008 Jul;69(1):33-40. doi: 10.1016/j.ijpsycho.2008.02.008. Epub 2008 Mar 5.
- Background: PubMed 38867444Roe G, Sawczuk T, Owen C, Tooby J, Starling L, Gilthorpe MS, Falvey E, Hendricks S, Rasmussen K, Readhead C, Salmon D, Stokes K, Tucker R, Jones B. Head Acceleration Events During Tackle, Ball-Carry, and Ruck Events in Professional Southern Hemisphere Men's Rugby Union Matches: A Study Using Instrumented Mouthguards. Scand J Med Sci Sports. 2024 Jun;34(6):e14676. doi: 10.1111/sms.14676.
- Background: PubMed 38460080Tooby J, Till K, Gardner A, Stokes K, Tierney G, Weaving D, Rowson S, Ghajari M, Emery C, Bussey MD, Jones B. When to Pull the Trigger: Conceptual Considerations for Approximating Head Acceleration Events Using Instrumented Mouthguards. Sports Med. 2024 Jun;54(6):1361-1369. doi: 10.1007/s40279-024-02012-5. Epub 2024 Mar 9.
- Background: PubMed 33135344Hicks SD, Onks C, Kim RY, Zhen KJ, Loeffert J, Loeffert AC, Olympia RP, Fedorchak G, DeVita S, Rangnekar A, Leddy J, Haider MN, Gagnon Z, McLoughlin CD, Badia M, Randall J, Madeira M, Yengo-Kahn AM, Wenzel J, Heller M, Zwibel H, Roberts A, Johnson S, Monteith C, Dretsch MN, Campbell TR, Mannix R, Neville C, Middleton F. Diagnosing mild traumatic brain injury using saliva RNA compared to cognitive and balance testing. Clin Transl Med. 2020 Oct;10(6):e197. doi: 10.1002/ctm2.197.
- Background: PubMed 39104376Woodward J, Tooby J, Tucker R, Falvey EC, Salmon DM, Starling L, Tierney G. Instrumented mouthguards in elite-level men's and women's rugby union: characterising tackle-based head acceleration events. BMJ Open Sport Exerc Med. 2024 Aug 1;10(3):e002013. doi: 10.1136/bmjsem-2024-002013. eCollection 2024.
- Background: PubMed 37938534Tooby J, Woodward J, Tucker R, Jones B, Falvey E, Salmon D, Bussey MD, Starling L, Tierney G. Correction to: Instrumented Mouthguards in Elite-Level Men's and Women's Rugby Union: The Incidence and Propensity of Head Acceleration Events in Matches. Sports Med. 2024 May;54(5):1339-1341. doi: 10.1007/s40279-023-01968-0. No abstract available.
- Background: PubMed 37340004Daneshvar DH, Nair ES, Baucom ZH, Rasch A, Abdolmohammadi B, Uretsky M, Saltiel N, Shah A, Jarnagin J, Baugh CM, Martin BM, Palmisano JN, Cherry JD, Alvarez VE, Huber BR, Weuve J, Nowinski CJ, Cantu RC, Zafonte RD, Dwyer B, Crary JF, Goldstein LE, Kowall NW, Katz DI, Stern RA, Tripodis Y, Stein TD, McClean MD, Alosco ML, McKee AC, Mez J. Leveraging football accelerometer data to quantify associations between repetitive head impacts and chronic traumatic encephalopathy in males. Nat Commun. 2023 Jun 20;14(1):3470. doi: 10.1038/s41467-023-39183-0.
- Background: PubMed 32881763Powell JR, Boltz AJ, DeCicco JP, Chandran A, DeLellis SM, Healy ML, Kane SF, Lynch JH, Means GE, Hackney AC, Mihalik JP. Neuroinflammatory Biomarkers Associated With Mild Traumatic Brain Injury History in Special Operations Forces Combat Soldiers. J Head Trauma Rehabil. 2020 Sep/Oct;35(5):300-307. doi: 10.1097/HTR.0000000000000598.
- Background: PubMed 30601825LaRocca D, Barns S, Hicks SD, Brindle A, Williams J, Uhlig R, Johnson P, Neville C, Middleton FA. Comparison of serum and saliva miRNAs for identification and characterization of mTBI in adult mixed martial arts fighters. PLoS One. 2019 Jan 2;14(1):e0207785. doi: 10.1371/journal.pone.0207785. eCollection 2019.
- Background: PubMed 32595592Janigro D, Kawata K, Silverman E, Marchi N, Diaz-Arrastia R. Is Salivary S100B a Biomarker of Traumatic Brain Injury? A Pilot Study. Front Neurol. 2020 Jun 12;11:528. doi: 10.3389/fneur.2020.00528. eCollection 2020.
- 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.
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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.
Malik KAHLI, 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 8 inclusion and 9 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 9 Apr 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?
Assess the intensity and number of impacts (time frame: 3 Years). 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 NCT07507253, which also lists 13 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 9 Apr 2026.