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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A00333-36 | Other Identifier | ANSM |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without mouthguard | Sham Comparator | Heading series without mouthguard from machine-projected soccer balls at standardized speeds |
|
| With mouthguard | Experimental | Heading series with mouthguard from machine-projected soccer balls at standardized speeds |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heading series | Procedure | 10 headers from machine-projected soccer balls at standardized speeds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean acceleration (m/s²) | Mean linear and rotational acceleration of the head | Week 4 |
| Mean acceleration (m/s²) | Mean linear and rotational acceleration of the head | Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Period of cortical silence (milliseconds) | Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings. | Week 4 |
| Period of cortical silence (milliseconds) |
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Inclusion Criteria:
Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hélène CASSOUDESALLE | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33 076 | France |
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| Magnetic Resonance Imaging (MRI) | Device | Brain MRI before and after a series |
|
| Cognitive computerized assessment | Other | Cognitive evaluation carried out with two computerized tools |
|
| Electrophysiological records | Procedure | Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG) |
|
| Dynamometer | Device | Measure of the strength of the neck muscles using a dynamometer |
|
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
| Week 6 |
| Normalized score | Normalized score (Z-score) on the subtests of the computerized cognitive battery | Week 4 |
| Normalized score | Normalized score (Z-score) on the subtests of the computerized cognitive battery | Week 6 |
| Average time | Average time on the subtests of the computerized cognitive battery | Week 4 |
| Average time | Average time on the subtests of the computerized cognitive battery | Week 6 |
| Mean strength ratio (Newton) | Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer | Week 4 |
| Mean strength ratio (Newton) | Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer | Week 6 |
| T-size measure | Functional connectivity at rest in MRI | Week 4 |
| T-size measure | Functional connectivity at rest in MRI | Week 6 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |
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| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D053581 | Muscle Strength Dynamometer |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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