<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04426188</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2019/45</org_study_id>
    <nct_id>NCT04426188</nct_id>
  </id_info>
  <brief_title>&quot; Acute Brain Changes After Repetitive Headers in Soccer and the Effects of a Protective Device &quot;</brief_title>
  <acronym>Soccer-BRAIN</acronym>
  <official_title>&quot; Brain Changes After Repetitive Head Impacts in Soccer and the Effects of a Protective Device: Biomechanical, Cognitive, Electrophysiological and Multimodal Neuroimaging Study &quot;</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Soccer, the most popular sport in the world, exposes players to repeated head impacts and&#xD;
      concussions, due to contact with another player or with the ground. Moreover, routine&#xD;
      game-play in soccer involves intentional and repeated head impacts through ball &quot;heading&quot;,&#xD;
      with frequent high velocities, which might cause a transient brain dysfunction. In this&#xD;
      pre-post prospective interventional study, 22 soccer players will perform 10 headers from&#xD;
      machine-projected soccer balls at standardized speeds, modelling routine soccer practice.&#xD;
      They will perform heading series in 2 different oral conditions, on different days at least 1&#xD;
      week apart: 1) Without mouthguard and tight jaws ; 2) With mouthguard and tight jaws. The&#xD;
      strength of the neck muscles will be measured before the heading series. The kinematic of the&#xD;
      movement will be recorded during each impact during the 2 heading series, as well as the&#xD;
      activity of the jaw muscles which will be recorded by electromyogram. Before and after each&#xD;
      heading series, electrophysiological data, multimodal magnetic resonance imaging (MRI), and&#xD;
      cognitive computerized assessment will be acquired&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 4, 2020</start_date>
  <completion_date type="Actual">January 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 7, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mean acceleration (m/s²)</measure>
    <time_frame>Week 4</time_frame>
    <description>Mean linear and rotational acceleration of the head</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean acceleration (m/s²)</measure>
    <time_frame>Week 6</time_frame>
    <description>Mean linear and rotational acceleration of the head</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Period of cortical silence (milliseconds)</measure>
    <time_frame>Week 4</time_frame>
    <description>Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Period of cortical silence (milliseconds)</measure>
    <time_frame>Week 6</time_frame>
    <description>Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normalized score</measure>
    <time_frame>Week 4</time_frame>
    <description>Normalized score (Z-score) on the subtests of the computerized cognitive battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Normalized score</measure>
    <time_frame>Week 6</time_frame>
    <description>Normalized score (Z-score) on the subtests of the computerized cognitive battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average time</measure>
    <time_frame>Week 4</time_frame>
    <description>Average time on the subtests of the computerized cognitive battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average time</measure>
    <time_frame>Week 6</time_frame>
    <description>Average time on the subtests of the computerized cognitive battery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean strength ratio (Newton)</measure>
    <time_frame>Week 4</time_frame>
    <description>Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean strength ratio (Newton)</measure>
    <time_frame>Week 6</time_frame>
    <description>Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T-size measure</measure>
    <time_frame>Week 4</time_frame>
    <description>Functional connectivity at rest in MRI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>T-size measure</measure>
    <time_frame>Week 6</time_frame>
    <description>Functional connectivity at rest in MRI</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <condition>Concussion, Brain</condition>
  <arm_group>
    <arm_group_label>Without mouthguard</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Heading series without mouthguard from machine-projected soccer balls at standardized speeds</description>
  </arm_group>
  <arm_group>
    <arm_group_label>With mouthguard</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heading series with mouthguard from machine-projected soccer balls at standardized speeds</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Heading series</intervention_name>
    <description>10 headers from machine-projected soccer balls at standardized speeds</description>
    <arm_group_label>With mouthguard</arm_group_label>
    <arm_group_label>Without mouthguard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <description>Brain MRI before and after a series</description>
    <arm_group_label>With mouthguard</arm_group_label>
    <arm_group_label>Without mouthguard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cognitive computerized assessment</intervention_name>
    <description>Cognitive evaluation carried out with two computerized tools</description>
    <arm_group_label>With mouthguard</arm_group_label>
    <arm_group_label>Without mouthguard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Electrophysiological records</intervention_name>
    <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)</description>
    <arm_group_label>With mouthguard</arm_group_label>
    <arm_group_label>Without mouthguard</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Dynamometer</intervention_name>
    <description>Measure of the strength of the neck muscles using a dynamometer</description>
    <arm_group_label>With mouthguard</arm_group_label>
    <arm_group_label>Without mouthguard</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male 18 to 25 years, enrolled in French Social Security, recruited from the soccer teams of&#xD;
        the University of Bordeaux&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Abnormal neurological examination&#xD;
&#xD;
          -  Taking drugs targeting the central nervous system&#xD;
&#xD;
          -  Any unhealed injury&#xD;
&#xD;
          -  History of head trauma, or other notion of central nervous system injury&#xD;
&#xD;
          -  History of severe high blood pressure, diabetes, chronic cardiovascular pathology,&#xD;
             progressive or debilitating disease&#xD;
&#xD;
          -  Family history of epilepsy&#xD;
&#xD;
          -  Contraindication to MRI: head circumference&gt; 60 - Claustrophobia - Pacemaker,&#xD;
             Implantable Neurostimulation, Implantable Defibrillator - Cochlear Implants - Ocular&#xD;
             or cerebral ferromagnetic foreign body - refusal to be informed of an anomaly detected&#xD;
             with MRI&#xD;
&#xD;
          -  Individuals under legal protection or unable of giving their informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hélène CASSOUDESALLE</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Bordeaux</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33 076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>June 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>March 26, 2021</last_update_submitted>
  <last_update_submitted_qc>March 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Soccer</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Heading</keyword>
  <keyword>Acceleration</keyword>
  <keyword>Neuroimaging</keyword>
  <keyword>Cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Injuries</mesh_term>
    <mesh_term>Brain Injuries, Traumatic</mesh_term>
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04426188
org study id: CHUBX 2019/45
nct id: NCT04426188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Mean acceleration (m/s²)
time frame: Week 4
description: Mean linear and rotational acceleration of the head
measure: Mean acceleration (m/s²)
time frame: Week 6
description: Mean linear and rotational acceleration of the head
measure: Period of cortical silence (milliseconds)
time frame: Week 4
description: Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
measure: Period of cortical silence (milliseconds)
time frame: Week 6
description: Corticomotor inhibition measured in milliseconds using transcranial magnetic stimulation and electromyographic recordings.
measure: Normalized score
time frame: Week 4
description: Normalized score (Z-score) on the subtests of the computerized cognitive battery
measure: Normalized score
time frame: Week 6
description: Normalized score (Z-score) on the subtests of the computerized cognitive battery
measure: Average time
time frame: Week 4
description: Average time on the subtests of the computerized cognitive battery
measure: Average time
time frame: Week 6
description: Average time on the subtests of the computerized cognitive battery
measure: Mean strength ratio (Newton)
time frame: Week 4
description: Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
measure: Mean strength ratio (Newton)
time frame: Week 6
description: Mean strength ratio between flexor and extensor muscles of the neck measured in Newton using a dynamometer
measure: T-size measure
time frame: Week 4
description: Functional connectivity at rest in MRI
measure: T-size measure
time frame: Week 6
description: Functional connectivity at rest in MRI
arm group label: Without mouthguard
arm group type: Sham Comparator
description: Heading series without mouthguard from machine-projected soccer balls at standardized speeds
arm group label: With mouthguard
arm group type: Experimental
description: Heading series with mouthguard from machine-projected soccer balls at standardized speeds
intervention type: Procedure
intervention name: Heading series
description: 10 headers from machine-projected soccer balls at standardized speeds
arm group label: With mouthguard
arm group label: Without mouthguard
intervention type: Device
intervention name: Magnetic Resonance Imaging (MRI)
description: Brain MRI before and after a series
arm group label: With mouthguard
arm group label: Without mouthguard
intervention type: Other
intervention name: Cognitive computerized assessment
description: Cognitive evaluation carried out with two computerized tools
arm group label: With mouthguard
arm group label: Without mouthguard
intervention type: Procedure
intervention name: Electrophysiological records
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)
arm group label: With mouthguard
arm group label: Without mouthguard
intervention type: Device
intervention name: Dynamometer
description: Measure of the strength of the neck muscles using a dynamometer
arm group label: With mouthguard
arm group label: Without mouthguard
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hélène CASSOUDESALLE
role: Principal Investigator
affiliation: University Hospital, Bordeaux
facility: 
country: France
responsible party type: Sponsor
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic
mesh term: Brain Concussion