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

NCT04426188 | Completed

• 1 other identifier: CHUBX 2019/45
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Traumatic Brain Injury; Concussion, Brain

Keywords

Soccer; Traumatic Brain Injury; Heading; Acceleration; Neuroimaging; Cognition

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• Period of cortical silence (milliseconds)

  Week 4

• Period of cortical silence (milliseconds)

  Week 6

• Normalized score

  Week 4

• Normalized score

  Week 6

• Average time

  Week 4

Study Arms (2)

Without mouthguard

SHAM COMPARATOR

Heading series without mouthguard from machine-projected soccer balls at standardized speeds

Procedure: Heading series; Device: Magnetic Resonance Imaging (MRI); Other: Cognitive computerized assessment; Procedure: Electrophysiological records; Device: Dynamometer

With mouthguard

EXPERIMENTAL

Heading series with mouthguard from machine-projected soccer balls at standardized speeds

Procedure: Heading series; Device: Magnetic Resonance Imaging (MRI); Other: Cognitive computerized assessment; Procedure: Electrophysiological records; Device: Dynamometer

Interventions

Heading series PROCEDURE

10 headers from machine-projected soccer balls at standardized speeds

With mouthguard; Without mouthguard

Magnetic Resonance Imaging (MRI) DEVICE

Brain MRI before and after a series

With mouthguard; Without mouthguard

Cognitive computerized assessment OTHER

Cognitive evaluation carried out with two computerized tools

With mouthguard; Without mouthguard

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)

With mouthguard; Without mouthguard

Dynamometer DEVICE

Measure of the strength of the neck muscles using a dynamometer

With mouthguard; Without mouthguard

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of the University of Bordeaux

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33 076, France

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Brain Concussion

Interventions

Magnetic Resonance Imaging; Muscle Strength Dynamometer

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Head Injuries, Closed; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Equipment; Equipment and Supplies

Study Officials

• Hélène CASSOUDESALLE

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2020
• First Posted: June 11, 2020
• Study Start: June 4, 2020
• Primary Completion: October 7, 2020
• Study Completion: January 15, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Locations

FR (1)