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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Completed

CT.gov ID

NCT04426188

Collaborator

(none)

Enrollment

Location

Arms

7.4

Actual Duration (Months)

2.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Traumatic Brain Injury Concussion, Brain	Procedure: Heading series Device: Magnetic Resonance Imaging (MRI) Other: Cognitive computerized assessment Procedure: Electrophysiological records Device: Dynamometer	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

21 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jun 4, 2020

Actual Primary Completion Date :

Oct 7, 2020

Actual Study Completion Date :

Jan 15, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Mean acceleration (m/s²) [Week 4]
Mean linear and rotational acceleration of the head
Mean acceleration (m/s²) [Week 6]
Mean linear and rotational acceleration of the head

Secondary Outcome Measures

Period of cortical silence (milliseconds) [Week 4]
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Period of cortical silence (milliseconds) [Week 6]
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Normalized score [Week 4]
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Normalized score [Week 6]
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Average time [Week 4]
Average time on the subtests of the computerized cognitive battery
Average time [Week 6]
Average time on the subtests of the computerized cognitive battery
Mean strength ratio (Newton) [Week 4]
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Mean strength ratio (Newton) [Week 6]
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
T-size measure [Week 4]
Functional connectivity at rest in MRI
T-size measure [Week 6]
Functional connectivity at rest in MRI

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 25 Years

Sexes Eligible for Study:

Male

Accepts 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