<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/NCT01720979</url>
  </required_header>
  <id_info>
    <org_study_id>NL37226.029.11</org_study_id>
    <nct_id>NCT01720979</nct_id>
  </id_info>
  <brief_title>TBI Project Amsterdam</brief_title>
  <official_title>Attention, Learning and Behaviour Following Traumatic Brain Injury in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marsh Königs</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>VU University of Amsterdam</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature&#xD;
      suggests a pivotal role for attentional functioning in neurocognitive and behavioural&#xD;
      consequences of paediatric TBI. Limitations of traditional neuropsychological measures of&#xD;
      attentional functioning have interfered with identification of the effect of paediatric TBI&#xD;
      on attentional networks so far. Moreover, the associations between attentional networks,&#xD;
      learning abilities, academic performance and behavioural and emotional problems following&#xD;
      paediatric TBI are yet to be explored.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:&#xD;
&#xD;
      Traumatic brain injury (TBI) is the world leading cause of disability in children (Winslade,&#xD;
      1998), causing deficits in motor function, neurocognition and adaptive behaviour (Anderson,&#xD;
      2001). Literature shows that age at injury is inversely related to the magnitude of deficits&#xD;
      following TBI, highlighting the vulnerability of children for the effects of TBI.&#xD;
&#xD;
      The neurocognitive consequences of paediatric TBI have primarily been characterized by&#xD;
      impairments in speed of information processing, attentional functioning and learning&#xD;
      (Babikian &amp; Asarnow, 2009; Catroppa &amp; Anderson, 2009), interfering with typical&#xD;
      neurocognitive development. We aim at elucidating the effects of TBI on neurocognitive&#xD;
      function and investigate the relations between neurocognitive deficits, academic achievement&#xD;
      and emotional and behavioural function, in order to improve our understanding of the&#xD;
      post-injury functioning of children that have suffered TBI.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Patients with TBI will be compared to a control group consisting of orthopedically injured&#xD;
      patients. Orthopaedic control (OC) groups offer a better comparison to TBI patients than&#xD;
      typically developing children by controlling for TBI risk factors related to neurocognition&#xD;
      (e.g. Attention Deficit Hyperactivity Disorder, socioeconomic status), hospitalisation and&#xD;
      the type of injuries other than brain injuries.&#xD;
&#xD;
      Measures:&#xD;
&#xD;
      Child's Orientation and Amnesia Test, Attention Network Test, Probabilistic Learning Test,&#xD;
      Child Behaviour Checklist, Strengths &amp; Difficulties Questionnaire, Experimental&#xD;
      Neurocognitive Test developed at the VU University and Pupil Monitoring System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2011</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The white-matter integrity of children with TBI will be compared to children with traumatic control injuries</measure>
    <time_frame>on average 1-year post-TBI</time_frame>
    <description>FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries</measure>
    <time_frame>on average 1-year post-TBI</time_frame>
    <description>Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries</measure>
    <time_frame>on average 1-year post-TBI</time_frame>
    <description>Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Academic achievement will be compared between children with TBI and children with traumatic control injuries</measure>
    <time_frame>on average 1-year post-TBI</time_frame>
    <description>Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries</measure>
    <time_frame>on average 1-year post-TBI</time_frame>
    <description>Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Traumatic Brain Injury</condition>
  <arm_group>
    <arm_group_label>Patients with traumatic injuries</arm_group_label>
    <description>Children that were admitted to the hospital after traumatic injuries to body parts below the clavicles (traumatic control injury) and children that were admitted to the hospital after traumatic brain injury as diagnosed by a physician (TBI).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Children that have been admitted to the hospital after sustaining trauma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        TBI patients will be included if they&#xD;
&#xD;
          -  have parental written informed consent&#xD;
&#xD;
          -  provide written informed consent if aged over 11 years&#xD;
&#xD;
          -  are Dutch speaking&#xD;
&#xD;
          -  have a clinical diagnosis of TBI (closed head injury)&#xD;
&#xD;
          -  have a time post-injury that is longer than 1 month&#xD;
&#xD;
          -  are aged between 6-12 years.&#xD;
&#xD;
        Trauma control patients will be included if they:&#xD;
&#xD;
          -  have parental written informed consent&#xD;
&#xD;
          -  provide written consent if aged over 11 years&#xD;
&#xD;
          -  are Dutch speaking&#xD;
&#xD;
          -  have suffered an orthopaedic injury&#xD;
&#xD;
          -  have no history of TBI&#xD;
&#xD;
          -  and are aged between 6-12 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaap Oosterlaan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VU University of Amsterdam</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Libra rehabilitation centers Blixembosch Leijpark</name>
      <address>
        <city>Eindhoven - Tilburg</city>
        <state>Brabant</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Academic Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1081</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU University of Amsterdam</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1081</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Merem revalidatiecentra de Trappenberg</name>
      <address>
        <city>Huizen</city>
        <state>Noord Holland</state>
        <zip>1081</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid Holland</state>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>October 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 2, 2012</study_first_posted>
  <last_update_submitted>December 2, 2015</last_update_submitted>
  <last_update_submitted_qc>December 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 3, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>VU University of Amsterdam</investigator_affiliation>
    <investigator_full_name>Marsh Königs</investigator_full_name>
    <investigator_title>MSc</investigator_title>
  </responsible_party>
  <keyword>TBI</keyword>
  <keyword>Traumatic Brain Injury</keyword>
  <keyword>Children</keyword>
  <keyword>Prognosis</keyword>
  <keyword>Neurocognition</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>
  </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/NCT01720979
org study id: NL37226.029.11
nct id: NCT01720979
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Traumatic Brain Injury (TBI) is the world leading cause of acquired brain injury. Literature
      suggests a pivotal role for attentional functioning in neurocognitive and behavioural
      consequences of paediatric TBI. Limitations of traditional neuropsychological measures of
      attentional functioning have interfered with identification of the effect of paediatric TBI
      on attentional networks so far. Moreover, the associations between attentional networks,
      learning abilities, academic performance and behavioural and emotional problems following
      paediatric TBI are yet to be explored.
Background:

      Traumatic brain injury (TBI) is the world leading cause of disability in children (Winslade,
      1998), causing deficits in motor function, neurocognition and adaptive behaviour (Anderson,
      2001). Literature shows that age at injury is inversely related to the magnitude of deficits
      following TBI, highlighting the vulnerability of children for the effects of TBI.

      The neurocognitive consequences of paediatric TBI have primarily been characterized by
      impairments in speed of information processing, attentional functioning and learning
      (Babikian & Asarnow, 2009; Catroppa & Anderson, 2009), interfering with typical
      neurocognitive development. We aim at elucidating the effects of TBI on neurocognitive
      function and investigate the relations between neurocognitive deficits, academic achievement
      and emotional and behavioural function, in order to improve our understanding of the
      post-injury functioning of children that have suffered TBI.

      Methods:

      Patients with TBI will be compared to a control group consisting of orthopedically injured
      patients. Orthopaedic control (OC) groups offer a better comparison to TBI patients than
      typically developing children by controlling for TBI risk factors related to neurocognition
      (e.g. Attention Deficit Hyperactivity Disorder, socioeconomic status), hospitalisation and
      the type of injuries other than brain injuries.

      Measures:

      Child's Orientation and Amnesia Test, Attention Network Test, Probabilistic Learning Test,
      Child Behaviour Checklist, Strengths & Difficulties Questionnaire, Experimental
      Neurocognitive Test developed at the VU University and Pupil Monitoring System.
observational model: Cohort
time perspective: Retrospective
measure: The white-matter integrity of children with TBI will be compared to children with traumatic control injuries
time frame: on average 1-year post-TBI
description: FA/ADC values will be reported for selected region's of interest in children with TBI and children with traumatic control injuries.
measure: Performance on tests of attention will be compared between children with TBI and children with traumatic control injuries
time frame: on average 1-year post-TBI
description: Mean reaction time and accuracy will be reported for children with TBI and children with traumatic control injuries
measure: Parental reports of behavioural regulation will be compared between children with TBI and children with traumatic control injuries
time frame: on average 1-year post-TBI
description: Problem scores on several types of behavioural problems will be reported for children with TBI and children with traumatic control injuries
measure: Academic achievement will be compared between children with TBI and children with traumatic control injuries
time frame: on average 1-year post-TBI
description: Scores on standardised tests of academic achievement will be reported for children with TBI and children with traumatic control injuries
measure: Performance on test of reinforced learning will be compared between children with TBI and children with traumatic control injuries
time frame: on average 1-year post-TBI
description: Reaction time and accuracy on computerised tests of reinforced learning will be reported for children with TBI and children with traumatic control injuries
arm group label: Patients with traumatic injuries
description: Children that were admitted to the hospital after traumatic injuries to body parts below the clavicles (traumatic control injury) and children that were admitted to the hospital after traumatic brain injury as diagnosed by a physician (TBI).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: No
last name: Jaap Oosterlaan, PhD
role: Principal Investigator
affiliation: VU University of Amsterdam
facility: 
facility: 
facility: 
facility: 
facility: 
country: Netherlands
responsible party type: Sponsor-Investigator
investigator affiliation: VU University of Amsterdam
investigator full name: Marsh Königs
investigator title: MSc
mesh term: Brain Injuries
mesh term: Brain Injuries, Traumatic