xml: <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/NCT06024122</url>
    </required_header>
    <id_info>
      <org_study_id>C22-48</org_study_id>
      <secondary_id>2022-A02619-34</secondary_id>
      <nct_id>NCT06024122</nct_id>
    </id_info>
    <brief_title>Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study</brief_title>
    <acronym>KAOUENN</acronym>
    <official_title>Brain Development in Young Children Following Mild Traumatic Brain Injury - Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Institut National de la Santé Et de la Recherche Médicale, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Institut National de Recherche en Informatique et en Automatique</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Institut National de la Santé Et de la Recherche Médicale, France</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>
        Concussions (also known as mild traumatic brain injury) are common in young children. In some&#xD;
        children, they can lead to short- and long-term difficulties. However, our knowledge of the&#xD;
        exact consequences of injuries on young children's brains and behavior is limited. These&#xD;
        consequences may be different in children under 6, as their brains are fragile and undergoing&#xD;
        significant developmental changes.&#xD;
  &#xD;
        The aim of this study is to determine the extent to which a concussion sustained before the&#xD;
        age of 6 years is associated with changes in young children's brain structure, function and&#xD;
        behaviours, using a brain imaging.&#xD;
  &#xD;
        In this study, the results of a group of 30 children with a concussion will be compared to&#xD;
        those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2, 2023</start_date>
    <completion_date type="Anticipated">February 27, 2025</completion_date>
    <primary_completion_date type="Anticipated">November 30, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Persistent brain structure alterations</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Persistent brain lesions - Volume</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>Volume of brain lesions measured with susceptibility MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Persistent brain lesions - Number</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>Number brain lesions measured with susceptibility MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cerebral blood flow alteration</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Functional integrity of brain networks</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Structural integrity of brain networks</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>White matter micro-structure measured by diffusion MRI</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Acute and persistent post-concussive symptoms</measure>
      <time_frame>Through study completion, an average of 3 months</time_frame>
      <description>Assessment of post-concussive symptoms using the REACTIONS questionnaire</description>
    </other_outcome>
    <other_outcome>
      <measure>Persistent behavioural difficulties</measure>
      <time_frame>3 months post-injury</time_frame>
      <description>Assessment of behaviour using the Strengths and Difficulties Questionnaire</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>TBI (Traumatic Brain Injury)</condition>
    <arm_group>
      <arm_group_label>Patients with a mTBI</arm_group_label>
      <description>Children with a mTBI aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control with an orthopaedic injury</arm_group_label>
      <description>Children with an orthopaedic injury aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>IRM exam</intervention_name>
      <description>A non-sedated MRI scan will be performed to assess the structure and function of the children's brains</description>
      <arm_group_label>Control with an orthopaedic injury</arm_group_label>
      <arm_group_label>Patients with a mTBI</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their&#xD;
          6th birthday) with mTBI.&#xD;
  &#xD;
          Children aged between 36 months (3 years) and 71 months and 31 days (5 years; before their&#xD;
          6th birthday) with orthopaedic injury (simple fracture, sprain, contusion or unspecified&#xD;
          trauma to a limb (mild))&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient group with mild traumatic brain injury (mTBI) :&#xD;
  &#xD;
                 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years;&#xD;
                    before their 6th birthday)&#xD;
  &#xD;
                 2. Presentation to the emergency department within 48 hours post-injury&#xD;
  &#xD;
                 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in&#xD;
                    non-penetrating head injury&#xD;
  &#xD;
                 4. Diagnosis of mTBI (World Health Organization (WHO) paediatric diagnostic&#xD;
                    criteria)&#xD;
  &#xD;
            -  Control group with orthopaedic injury:&#xD;
  &#xD;
                 1. Children aged between 36 months (3 years) and 71 months and 31 days (5 years;&#xD;
                    before their 6th birthday)&#xD;
  &#xD;
                 2. Presentation to the emergency department within 48 hours post-injury&#xD;
  &#xD;
                 3. Documented, unintentional traumatic event (e.g. blow, fall, etc.) resulting in&#xD;
                    trauma to an upper or lower limb&#xD;
  &#xD;
                 4. Diagnosis of simple fracture, sprain, contusion or unspecified trauma to a limb&#xD;
                    (mild).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of previous TBI (any severity, any age)&#xD;
  &#xD;
            -  Intentional injury,&#xD;
  &#xD;
            -  Administration of sedative drugs that can alter brain function&#xD;
  &#xD;
            -  Complications following injury&#xD;
  &#xD;
            -  MRI contraindication,&#xD;
  &#xD;
            -  Parent non-fluent in French,&#xD;
  &#xD;
            -  Prematurity,&#xD;
  &#xD;
            -  Diagnosis of a severe neurological, developmental, or psychiatric disorder&#xD;
  &#xD;
            -  Children in foster care at the time of recruitment&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>36 Months</minimum_age>
      <maximum_age>71 Months</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Fanny DÉGEILH, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Institut National de la Santé Et de la Recherche Médicale, France</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Fanny DÉGEILH, PhD</last_name>
      <phone>+33 2 99 84 71 63</phone>
      <email>fanny.degeilh@inserm.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Véronique CHASLE, MD</last_name>
      <phone>+33 2 99 26 67 58</phone>
      <email>veronique.chasle@chu-rennes.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Unité des urgences médicochirurgicales CHU Rennes</name>
        <address>
          <city>Rennes</city>
          <zip>35200</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Véronique Chasle, MD</last_name>
        <phone>+33 2 99 26 67 58</phone>
        <email>veronique.chasle@chu-rennes.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 28, 2023</last_update_submitted>
    <last_update_submitted_qc>August 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024122
  org study id: C22-48
  secondary id: 2022-A02619-34
  nct id: NCT06024122
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Concussions (also known as mild traumatic brain injury) are common in young children. In some
        children, they can lead to short- and long-term difficulties. However, our knowledge of the
        exact consequences of injuries on young children's brains and behavior is limited. These
        consequences may be different in children under 6, as their brains are fragile and undergoing
        significant developmental changes.
  
        The aim of this study is to determine the extent to which a concussion sustained before the
        age of 6 years is associated with changes in young children's brain structure, function and
        behaviours, using a brain imaging.
  
        In this study, the results of a group of 30 children with a concussion will be compared to
        those of 30 children of the same age with an orthopaedic injury to the upper or lower limbs.
  observational model: Case-Control
  time perspective: Prospective
  measure: Persistent brain structure alterations
  time frame: 3 months post-injury
  description: Quantitative assessment of the brain morphometry extracted from T1-w MRI sequence
  measure: Persistent brain lesions - Volume
  time frame: 3 months post-injury
  description: Volume of brain lesions measured with susceptibility MRI
  measure: Persistent brain lesions - Number
  time frame: 3 months post-injury
  description: Number brain lesions measured with susceptibility MRI
  measure: Cerebral blood flow alteration
  time frame: 3 months post-injury
  description: Cerebral blood flow quantified by arterial spin labelling perfusion MRI (ASL)
  measure: Functional integrity of brain networks
  time frame: 3 months post-injury
  description: Functional connectivity (i.e., correlation between the activation of brain regions) measured by resting-state functional MRI
  measure: Structural integrity of brain networks
  time frame: 3 months post-injury
  description: White matter micro-structure measured by diffusion MRI
  measure: Acute and persistent post-concussive symptoms
  time frame: Through study completion, an average of 3 months
  description: Assessment of post-concussive symptoms using the REACTIONS questionnaire
  measure: Persistent behavioural difficulties
  time frame: 3 months post-injury
  description: Assessment of behaviour using the Strengths and Difficulties Questionnaire
  arm group label: Patients with a mTBI
  description: Children with a mTBI aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.
  arm group label: Control with an orthopaedic injury
  description: Children with an orthopaedic injury aged 3 to 5 years (i.e., up to 71 months and 31 days, i.e., before the 6th birthday) recruited from the paediatric emergency department of Rennes University Hospital.
  intervention type: Other
  intervention name: IRM exam
  description: A non-sedated MRI scan will be performed to assess the structure and function of the children's brains
  arm group label: Control with an orthopaedic injury
  arm group label: Patients with a mTBI
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 36 Months
  maximum age: 71 Months
  healthy volunteers: No
  last name: Fanny DÉGEILH, PhD
  role: Study Director
  affiliation: Institut National de la Santé Et de la Recherche Médicale, France
  last name: Fanny DÉGEILH, PhD
  phone: +33 2 99 84 71 63
  email: fanny.degeilh@inserm.fr
  last name: Véronique CHASLE, MD
  phone: +33 2 99 26 67 58
  email: veronique.chasle@chu-rennes.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Brain Injuries
  mesh term: Brain Injuries, Traumatic
  mesh term: Brain Concussion
  mesh term: Wounds and Injuries