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Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device

Brain Changes After Repetitive Head Impacts in Soccer and the Effects of a Protective Device: Biomechanical, Cognitive, Electrophysiological and Multimodal Neuroimaging Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04426188
Acronym
Soccer-BRAIN
Enrollment
21
Registered
2020-06-11
Start date
2020-06-04
Completion date
2021-01-15
Last updated
2021-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Traumatic Brain Injury, Concussion, Brain

Keywords

Soccer, Traumatic Brain Injury, Heading, Acceleration, Neuroimaging, Cognition

Brief 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 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

Interventions

PROCEDUREHeading series

10 headers from machine-projected soccer balls at standardized speeds

DEVICEMagnetic Resonance Imaging (MRI)

Brain MRI before and after a series

OTHERCognitive computerized assessment

Cognitive evaluation carried out with two computerized tools

PROCEDUREElectrophysiological records

Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG)

Measure of the strength of the neck muscles using a dynamometer

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 25 Years
Healthy volunteers
Yes

Inclusion criteria

Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mean acceleration (m/s²)Week 4Mean linear and rotational acceleration of the head

Secondary

MeasureTime frameDescription
Period of cortical silence (milliseconds)Week 4Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Normalized scoreWeek 4Normalized score (Z-score) on the subtests of the computerized cognitive battery
Average timeWeek 4Average time on the subtests of the computerized cognitive battery
Mean strength ratio (Newton)Week 4Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
T-size measureWeek 4Functional connectivity at rest in MRI

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026