<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/NCT02217696</url>
  </required_header>
  <id_info>
    <org_study_id>LEXI SNF32003B_141201/1</org_study_id>
    <secondary_id>32003B_141201/1</secondary_id>
    <nct_id>NCT02217696</nct_id>
  </id_info>
  <brief_title>Prediction and Intervention in Developmental Dyslexia</brief_title>
  <acronym>LEXI</acronym>
  <official_title>Neuronal Markers of Grapheme-phoneme Training Response for Prediction of Successful Reading Acquisition in Children at Familial Risk for Developmental Dyslexia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The long-term goal of this study is to improve prediction of poor reading outcome at&#xD;
      preschool age by using a combination of behavioural and neuroimaging measures and to evaluate&#xD;
      a specific computerized training program to support children with problems during reading&#xD;
      acquisition.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">July 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in reading and spelling performance</measure>
    <time_frame>Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months</time_frame>
    <description>Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Developmental and training induced changes in functional brain activation and brain structure</measure>
    <time_frame>Participants will be tested after an expected average of 8, 12 and 16 months</time_frame>
    <description>Changes in activation/structure of core language network regions assessed by EEG and MRI during development, learning and training</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accuracy of prediction on reading performance outcome</measure>
    <time_frame>Participants will be tested at T1 and on average 8 months later</time_frame>
    <description>Accuracy of prediction on reading performance (standardized tests) using behavioural and/or neuroimaging measures.&#xD;
Neuroimaging measures: EEG and MRI (functional activation, structural measures from white and/or grey matter, temporal information from event-related potential and/or frequency analyses)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">110</enrollment>
  <condition>Developmental Dyslexia</condition>
  <arm_group>
    <arm_group_label>Computerized reading training first</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cross-over design: group first receives the intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waiting Control First</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Cross-over design: group first serves as waiting control</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Computerized reading training</intervention_name>
    <arm_group_label>Computerized reading training first</arm_group_label>
    <arm_group_label>Waiting Control First</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for all groups:&#xD;
&#xD;
          -  Healthy, native (CH-) German speaking subjects, with an estimated non-verbal&#xD;
             intelligence quotient (IQ) &gt;=80, without neurological and/or psychiatric disorder&#xD;
             (except for attention deficit hyperactivity disorder, specific learning disorders,&#xD;
             developmental language impairments)&#xD;
&#xD;
          -  Additional criteria for subgroups:&#xD;
&#xD;
          -  Recruitment of preschoolers (aged 5.5-7.5 years):&#xD;
&#xD;
          -  Healthy children with increased risk for developmental dyslexia in their second year&#xD;
             at kindergarten&#xD;
&#xD;
          -  Recruitment of children in first grade (aged 6.5-8.5years):&#xD;
&#xD;
          -  Children showing impairments in learning to read (first/second grade).&#xD;
&#xD;
          -  Adults (aged 20-40 years):&#xD;
&#xD;
          -  Healthy, normal reading&#xD;
&#xD;
        Exclusion Criteria for all groups:&#xD;
&#xD;
          -  MRI contraindications&#xD;
&#xD;
          -  No history of premature delivery and/or maternal reports of severe prenatal, perinatal&#xD;
             or postnatal complications.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Silvia Brem, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Clinics for Child and Adolescent Psychiatry, University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Silvia Brem, PhD</last_name>
    <phone>+41 43 499 2760</phone>
    <email>sbrem@kjpd.uzh.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Clinics for Child and Adolescent Psychiatry, University of Zurich</name>
      <address>
        <city>Zurich</city>
        <zip>8032</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Silvia Brem, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 8, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 13, 2014</last_update_submitted>
  <last_update_submitted_qc>August 13, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electroencephalography (EEG)</keyword>
  <keyword>Magnetic Resonance Imaging (MRI)</keyword>
  <keyword>Multimodal Neuroimaging</keyword>
  <keyword>Development</keyword>
  <keyword>Prediction</keyword>
  <keyword>Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyslexia</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/NCT02217696
org study id: LEXI SNF32003B_141201/1
secondary id: 32003B_141201/1
nct id: NCT02217696
lead sponsor: 
has dmc: Yes
The long-term goal of this study is to improve prediction of poor reading outcome at
      preschool age by using a combination of behavioural and neuroimaging measures and to evaluate
      a specific computerized training program to support children with problems during reading
      acquisition.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Outcomes Assessor)
measure: Changes in reading and spelling performance
time frame: Participants will be tested at three times for the duration of the cross-sectional intervention, an expected average of 8 months
description: Performance in normed reading and/or spelling (standardized tests) as a result of reading acquisition and training
measure: Developmental and training induced changes in functional brain activation and brain structure
time frame: Participants will be tested after an expected average of 8, 12 and 16 months
description: Changes in activation/structure of core language network regions assessed by EEG and MRI during development, learning and training
measure: Accuracy of prediction on reading performance outcome
time frame: Participants will be tested at T1 and on average 8 months later
description: Accuracy of prediction on reading performance (standardized tests) using behavioural and/or neuroimaging measures.
Neuroimaging measures: EEG and MRI (functional activation, structural measures from white and/or grey matter, temporal information from event-related potential and/or frequency analyses)
arm group label: Computerized reading training first
arm group type: Experimental
description: Cross-over design: group first receives the intervention
arm group label: Waiting Control First
arm group type: Experimental
description: Cross-over design: group first serves as waiting control
intervention type: Other
intervention name: Computerized reading training
arm group label: Computerized reading training first
arm group label: Waiting Control First
criteria: 
gender: All
minimum age: 5 Years
maximum age: 9 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Silvia Brem, PhD
role: Principal Investigator
affiliation: University Clinics for Child and Adolescent Psychiatry, University of Zurich
last name: Silvia Brem, PhD
phone: +41 43 499 2760
email: sbrem@kjpd.uzh.ch
facility: 
status: Recruiting
investigator: 
country: Switzerland
responsible party type: Sponsor
mesh term: Dyslexia