Skip to main content
OpenTrials
Completed

NCT Number: NCT04426188

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

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

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–25 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Bordeaux

Bordeaux, 33 076, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Heading series

Procedure

10 headers from machine-projected soccer balls at standardized speeds

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

Primary outcomes

  1. Mean acceleration (m/s²)

    Time frame: Week 4

    Mean linear and rotational acceleration of the head

  2. Mean acceleration (m/s²)

    Time frame: Week 6

    Mean linear and rotational acceleration of the head

Secondary outcomes

  1. Period of cortical silence (milliseconds)

    Time frame: Week 4

    Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.

  2. Period of cortical silence (milliseconds)

    Time frame: Week 6

    Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.

  3. Normalized score

    Time frame: Week 4

    Normalized score (Z-score) on the subtests of the computerized cognitive battery

  4. Normalized score

    Time frame: Week 6

    Normalized score (Z-score) on the subtests of the computerized cognitive battery

  5. Average time

    Time frame: Week 4

    Average time on the subtests of the computerized cognitive battery

  6. Average time

    Time frame: Week 6

    Average time on the subtests of the computerized cognitive battery

  7. Mean strength ratio (Newton)

    Time frame: Week 4

    Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer

  8. Mean strength ratio (Newton)

    Time frame: Week 6

    Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer

  9. T-size measure

    Time frame: Week 4

    Functional connectivity at rest in MRI

  10. T-size measure

    Time frame: Week 6

    Functional connectivity at rest in MRI

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: Soccer-BRAIN

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jun 11, 2020
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.