" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device " (Soccer-BRAIN)
Primary Purpose
Traumatic Brain Injury, Concussion, Brain
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Heading series
Magnetic Resonance Imaging (MRI)
Cognitive computerized assessment
Electrophysiological records
Dynamometer
Sponsored by
About this trial
This is an interventional prevention trial for Traumatic Brain Injury focused on measuring Soccer, Traumatic Brain Injury, Heading, Acceleration, Neuroimaging, Cognition
Eligibility Criteria
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
Sites / Locations
- CHU de Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Experimental
Arm Label
Without mouthguard
With mouthguard
Arm Description
Heading series without mouthguard from machine-projected soccer balls at standardized speeds
Heading series with mouthguard from machine-projected soccer balls at standardized speeds
Outcomes
Primary Outcome Measures
Mean acceleration (m/s²)
Mean linear and rotational acceleration of the head
Mean acceleration (m/s²)
Mean linear and rotational acceleration of the head
Secondary Outcome Measures
Period of cortical silence (milliseconds)
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Period of cortical silence (milliseconds)
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Normalized score
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Normalized score
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Average time
Average time on the subtests of the computerized cognitive battery
Average time
Average time on the subtests of the computerized cognitive battery
Mean strength ratio (Newton)
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Mean strength ratio (Newton)
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
T-size measure
Functional connectivity at rest in MRI
T-size measure
Functional connectivity at rest in MRI
Full Information
NCT ID
NCT04426188
First Posted
May 28, 2020
Last Updated
March 26, 2021
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04426188
Brief Title
" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
Acronym
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 "
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 4, 2020 (Actual)
Primary Completion Date
October 7, 2020 (Actual)
Study Completion Date
January 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Concussion, Brain
Keywords
Soccer, Traumatic Brain Injury, Heading, Acceleration, Neuroimaging, Cognition
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Without mouthguard
Arm Type
Sham Comparator
Arm Description
Heading series without mouthguard from machine-projected soccer balls at standardized speeds
Arm Title
With mouthguard
Arm Type
Experimental
Arm Description
Heading series with mouthguard from machine-projected soccer balls at standardized speeds
Intervention Type
Procedure
Intervention Name(s)
Heading series
Intervention Description
10 headers from machine-projected soccer balls at standardized speeds
Intervention Type
Device
Intervention Name(s)
Magnetic Resonance Imaging (MRI)
Intervention Description
Brain MRI before and after a series
Intervention Type
Other
Intervention Name(s)
Cognitive computerized assessment
Intervention Description
Cognitive evaluation carried out with two computerized tools
Intervention Type
Procedure
Intervention Name(s)
Electrophysiological records
Intervention Description
Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG)
Intervention Type
Device
Intervention Name(s)
Dynamometer
Intervention Description
Measure of the strength of the neck muscles using a dynamometer
Primary Outcome Measure Information:
Title
Mean acceleration (m/s²)
Description
Mean linear and rotational acceleration of the head
Time Frame
Week 4
Title
Mean acceleration (m/s²)
Description
Mean linear and rotational acceleration of the head
Time Frame
Week 6
Secondary Outcome Measure Information:
Title
Period of cortical silence (milliseconds)
Description
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Time Frame
Week 4
Title
Period of cortical silence (milliseconds)
Description
Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
Time Frame
Week 6
Title
Normalized score
Description
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Time Frame
Week 4
Title
Normalized score
Description
Normalized score (Z-score) on the subtests of the computerized cognitive battery
Time Frame
Week 6
Title
Average time
Description
Average time on the subtests of the computerized cognitive battery
Time Frame
Week 4
Title
Average time
Description
Average time on the subtests of the computerized cognitive battery
Time Frame
Week 6
Title
Mean strength ratio (Newton)
Description
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Time Frame
Week 4
Title
Mean strength ratio (Newton)
Description
Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
Time Frame
Week 6
Title
T-size measure
Description
Functional connectivity at rest in MRI
Time Frame
Week 4
Title
T-size measure
Description
Functional connectivity at rest in MRI
Time Frame
Week 6
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hélène CASSOUDESALLE
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
ZIP/Postal Code
33 076
Country
France
12. IPD Sharing Statement
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" Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device "
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