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

Traumatic Brain Injury Clinical Trial

— Soccer-BRAIN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426188
• Other study ID #: CHUBX 2019/45
• Status: Completed
• Phase: N/A
• Start date: June 4, 2020
• Est. completion date: January 15, 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: January 15, 2021
• Est. primary completion date: October 7, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion
• Brain Injuries
• Brain Injuries, Traumatic
• Concussion, Brain
• Traumatic Brain Injury

Intervention

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

Locations

Country	Name	City	State
France	CHU de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean acceleration (m/s²)	Mean linear and rotational acceleration of the head	Week 4
Primary	Mean acceleration (m/s²)	Mean linear and rotational acceleration of the head	Week 6
Secondary	Period of cortical silence (milliseconds)	Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.	Week 4
Secondary	Period of cortical silence (milliseconds)	Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.	Week 6
Secondary	Normalized score	Normalized score (Z-score) on the subtests of the computerized cognitive battery	Week 4
Secondary	Normalized score	Normalized score (Z-score) on the subtests of the computerized cognitive battery	Week 6
Secondary	Average time	Average time on the subtests of the computerized cognitive battery	Week 4
Secondary	Average time	Average time on the subtests of the computerized cognitive battery	Week 6
Secondary	Mean strength ratio (Newton)	Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer	Week 4
Secondary	Mean strength ratio (Newton)	Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer	Week 6
Secondary	T-size measure	Functional connectivity at rest in MRI	Week 4
Secondary	T-size measure	Functional connectivity at rest in MRI	Week 6