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

U

University Hospital of Bordeaux

Status

Completed

Conditions

Traumatic Brain Injury
Concussion, Brain

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04426188
CHUBX 2019/45

Details and patient eligibility

About

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

Enrollment

21 patients

Sex

Male

Ages

18 to 25 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

21 participants in 2 patient groups

Without mouthguard
Sham Comparator group
Description:
Heading series without mouthguard from machine-projected soccer balls at standardized speeds
Treatment:
Device: Magnetic Resonance Imaging (MRI)
Device: Dynamometer
Procedure: Heading series
Other: Cognitive computerized assessment
Procedure: Electrophysiological records
With mouthguard
Experimental group
Description:
Heading series with mouthguard from machine-projected soccer balls at standardized speeds
Treatment:
Device: Magnetic Resonance Imaging (MRI)
Device: Dynamometer
Procedure: Heading series
Other: Cognitive computerized assessment
Procedure: Electrophysiological records

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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