Traumatic Brain InjurySoccer-BRAINNCT04426188
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
A study testing Heading series, Magnetic Resonance Imaging (MRI) and Cognitive computerized assessment in people with Traumatic Brain Injury and Concussion, Brain, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a… Read more about this study
- Who is it for?
- Ages 18 to 25 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Concussion, Brain
- What is being tested?
- Heading series, Magnetic Resonance Imaging (MRI) and Cognitive computerized assessment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 4 Jun 2020to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 25 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux
Who cannot join
- Abnormal neurological examination
- Taking drugs targeting the central nervous system
- Any unhealed injury
- History of head trauma, or other notion of central nervous system injury
- History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
- Family history of epilepsy
- Contraindication to MRI: head circumference> 60 - Claustrophobia - Pacemaker, Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular or cerebral ferromagnetic foreign body - refusal to be informed of an anomaly detected with MRI
- Individuals under legal protection or unable of giving their informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: " Brain Changes After Repetitive Head Impacts in Soccer and the Effects of a Protective Device: Biomechanical, Cognitive, Electrophysiological and Multimodal Neuroimaging Study "
Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired
- Conditions
- Traumatic Brain Injury, Concussion, Brain
- Being tested
- Heading series, Magnetic Resonance Imaging (MRI), Cognitive computerized assessment, Electrophysiological records, Dynamometer
- Keywords
- Soccer, Traumatic Brain Injury, Heading, Acceleration, Neuroimaging, Cognition
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heading seriesProcedure or surgery
10 headers from machine-projected soccer balls at standardized speeds
Magnetic Resonance Imaging (MRI)Device
Brain MRI before and after a series
Cognitive computerized assessmentOther
Cognitive evaluation carried out with two computerized tools
Electrophysiological recordsProcedure or surgery
Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG)
DynamometerDevice
Measure of the strength of the neck muscles using a dynamometer
| Study group | Role | What they receive |
|---|---|---|
| Without mouthguard | Sham comparator | Heading series without mouthguard from machine-projected soccer balls at standardized speeds Receives: Procedure: Heading series; Device: Magnetic Resonance Imaging (MRI); Other: Cognitive computerized assessment; Procedure: Electrophysiological records; Device: Dynamometer |
| With mouthguard | Experimental | Heading series with mouthguard from machine-projected soccer balls at standardized speeds Receives: Procedure: Heading series; Device: Magnetic Resonance Imaging (MRI); Other: Cognitive computerized assessment; Procedure: Electrophysiological records; Device: Dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean acceleration (m/s²)
Mean linear and rotational acceleration of the head
Measured: Week 4
Mean acceleration (m/s²)
Mean linear and rotational acceleration of the head
Measured: Week 6
Secondary outcomes (10)
Period of cortical silence (milliseconds)
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Measured: Week 4
Period of cortical silence (milliseconds)
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Measured: Week 6
Normalized score
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Measured: Week 4
Normalized score
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Measured: Week 6
Average time
Average time on the subtests of the computerized cognitive battery
Measured: Week 4
Average time
Average time on the subtests of the computerized cognitive battery
Measured: Week 6
Mean strength ratio (Newton)
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Measured: Week 4
Mean strength ratio (Newton)
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Measured: Week 6
T-size measure
Functional connectivity at rest in MRI
Measured: Week 4
T-size measure
Functional connectivity at rest in MRI
Measured: Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start4 Jun 2020
- Primary completion7 Oct 2020
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hélène CASSOUDESALLE, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426188
- Sponsor's protocol ID
- CHUBX 2019/45
- Other IDs
- 2020-A00333-36
- Acronym
- Soccer-BRAIN
- Status last verified
- Mar 2021
- First submitted
- 28 May 2020
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- " Brain Changes After Repetitive Head Impacts in Soccer and the Effects of a Protective Device: Biomechanical, Cognitive, Electrophysiological and Multimodal Neuroimaging Study "
- ClinicalTrials.gov ID
- NCT04426188
- Acronym / sponsor ID
- Soccer-BRAIN / CHUBX 2019/45
- Conditions
- Traumatic Brain Injury, Concussion, Brain
- Keywords
- Soccer, Traumatic Brain Injury, Heading, Acceleration, Neuroimaging, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 4 Jun 2020 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 11 Jun 2020 (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.
Soccer, the most popular sport in the world, exposes players to repeated head impacts and concussions, due to contact with another player or with the ground. Moreover, routine game-play in soccer involves intentional and repeated head impacts through ball "heading", with frequent high velocities, which might cause a transient brain dysfunction. In this pre-post prospective interventional study, 22 soccer players will perform 10 headers from machine-projected soccer balls at standardized speeds, modelling routine soccer practice. They will perform heading series in 2 different oral conditions, on different days at least 1 week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The strength of the neck muscles will be measured before the heading series. The kinematic of the movement will be recorded during each impact during the 2 heading series, as well as the activity of the jaw muscles which will be recorded by electromyogram. Before and after each heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and cognitive computerized assessment will be acquired
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Without mouthguard | Sham comparator | Procedure: Heading series, Device: Magnetic Resonance Imaging (MRI), Other: Cognitive computerized assessment, Procedure: Electrophysiological records, Device: DynamometerHeading series without mouthguard from machine-projected soccer balls at standardized speeds |
| With mouthguard | Experimental | Procedure: Heading series, Device: Magnetic Resonance Imaging (MRI), Other: Cognitive computerized assessment, Procedure: Electrophysiological records, Device: DynamometerHeading series with mouthguard from machine-projected soccer balls at standardized speeds |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux
Key exclusion criteria (8 listed)
- Abnormal neurological examination
- Taking drugs targeting the central nervous system
- Any unhealed injury
- History of head trauma, or other notion of central nervous system injury
- History of severe high blood pressure, diabetes, chronic cardiovascular pathology, progressive or debilitating disease
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 |
|---|---|---|
| Heading series10 headers from machine-projected soccer balls at standardized speeds | Procedure or surgery | With mouthguard, Without mouthguard |
| Magnetic Resonance Imaging (MRI)Brain MRI before and after a series | Device | With mouthguard, Without mouthguard |
| Cognitive computerized assessmentCognitive evaluation carried out with two computerized tools | Other | With mouthguard, Without mouthguard |
| Electrophysiological recordsElectrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG) | Procedure or surgery | With mouthguard, Without mouthguard |
| DynamometerMeasure of the strength of the neck muscles using a dynamometer | Device | With mouthguard, Without mouthguard |
Primary outcome
Mean acceleration (m/s²)
Time frame: Week 4
Mean linear and rotational acceleration of the head
Mean acceleration (m/s²)
Time frame: Week 6
Mean linear and rotational acceleration of the head
10 secondary outcomes
Period of cortical silence (milliseconds)
Time frame: Week 4
Period of cortical silence (milliseconds)
Time frame: Week 6
Normalized score
Time frame: Week 4
Normalized score
Time frame: Week 6
Average time
Time frame: Week 4
Average time
Time frame: Week 6
Mean strength ratio (Newton)
Time frame: Week 4
Mean strength ratio (Newton)
Time frame: Week 6
T-size measure
Time frame: Week 4
T-size measure
Time frame: Week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
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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. This study is not recruiting at the moment.
Hélène CASSOUDESALLE principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heading series, Magnetic Resonance Imaging (MRI) and Cognitive computerized assessment in people with Traumatic Brain Injury and Concussion, Brain, run by University Hospital, Bordeaux 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 1 inclusion and 8 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: finished, as of the sponsor's last update on 29 May 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean acceleration (m/s²) (time frame: Week 4). 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?
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 29 May 2026.