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

" 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

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Concussion, Brain
• Intervention / Treatment: Procedure: Heading series; Device: Magnetic Resonance Imaging (MRI); Other: Cognitive computerized assessment; Procedure: Electrophysiological records; Device: Dynamometer

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33 076
    • CHU de Bordeaux

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Without mouthguard; Heading series without mouthguard from machine-projected soccer balls at standardized speeds	Procedure: Heading series; 10 headers from machine-projected soccer balls at standardized speeds; Device: Magnetic Resonance Imaging (MRI); Brain MRI before and after a series; Other: Cognitive computerized assessment; Cognitive evaluation carried out with two computerized tools; Procedure: Electrophysiological 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); Device: Dynamometer; Measure of the strength of the neck muscles using a dynamometer
Experimental: With mouthguard; Heading series with mouthguard from machine-projected soccer balls at standardized speeds	Procedure: Heading series; 10 headers from machine-projected soccer balls at standardized speeds; Device: Magnetic Resonance Imaging (MRI); Brain MRI before and after a series; Other: Cognitive computerized assessment; Cognitive evaluation carried out with two computerized tools; Procedure: Electrophysiological 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); Device: Dynamometer; Measure of the strength of the neck muscles using a dynamometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Helene CASSOUDESALLE, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2020
• Primary Completion (Actual): October 7, 2020
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: May 28, 2020
• First Submitted That Met QC Criteria: June 9, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): March 29, 2021
• Last Update Submitted That Met QC Criteria: March 26, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Soccer; Cognition; Neuroimaging; Traumatic Brain Injury; Acceleration; Heading
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: CHUBX 2019/45

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No