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

Not Applicable

Completed

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

• Registration Number: NCT04426188
• Lead Sponsor: University Hospital, Bordeaux

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-28
• Study Start: 2020-06-04
• Study First Submitted QC: 2020-06-09
• Study First Posted: 2020-06-11
• Primary Completion: 2020-10-07
• Study Completion: 2021-01-15
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-26
• Last Update Posted: 2021-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Without mouthguard	Magnetic Resonance Imaging (MRI)	Heading series without mouthguard from machine-projected soccer balls at standardized speeds
With mouthguard	Magnetic Resonance Imaging (MRI)	Heading series with mouthguard from machine-projected soccer balls at standardized speeds
Without mouthguard	Electrophysiological records	Heading series without mouthguard from machine-projected soccer balls at standardized speeds
With mouthguard	Cognitive computerized assessment	Heading series with mouthguard from machine-projected soccer balls at standardized speeds
With mouthguard	Electrophysiological records	Heading series with mouthguard from machine-projected soccer balls at standardized speeds
With mouthguard	Dynamometer	Heading series with mouthguard from machine-projected soccer balls at standardized speeds
Without mouthguard	Dynamometer	Heading series without mouthguard from machine-projected soccer balls at standardized speeds
Without mouthguard	Heading series	Heading series without mouthguard from machine-projected soccer balls at standardized speeds
Without mouthguard	Cognitive computerized assessment	Heading series without mouthguard from machine-projected soccer balls at standardized speeds
With mouthguard	Heading series	Heading series with mouthguard from machine-projected soccer balls at standardized speeds

Primary Outcome Measures

Name	Time	Method
Mean acceleration (m/s²)	Week 6	Mean linear and rotational acceleration of the head

Secondary Outcome Measures

Name	Time	Method
Normalized score	Week 6	Normalized score (Z-score) on the subtests of the computerized cognitive battery
Average time	Week 6	Average time on the subtests of the computerized cognitive battery
T-size measure	Week 6	Functional connectivity at rest in MRI
Mean strength ratio (Newton)	Week 6	Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Period of cortical silence (milliseconds)	Week 6	Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.

Trial Locations

Locations (1)

CHU de Bordeaux; 🇫🇷 Bordeaux, France