<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/NCT02253290</url>
  </required_header>
  <id_info>
    <org_study_id>S57182</org_study_id>
    <nct_id>NCT02253290</nct_id>
  </id_info>
  <brief_title>Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease</brief_title>
  <official_title>Neuropsychological and Psychosocial Follow up of Children and Adolescents With Neuromuscular Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitaire Ziekenhuizen KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitaire Ziekenhuizen KU Leuven</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project is a retrospective and prospective investigation of neuropsychological and&#xD;
      psychosocial development of children with a neuromuscular disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This project is a retrospective and prospective investigation of neuropsychological and&#xD;
      psychosocial development of children with a neuromuscular disease. Children and adolescents&#xD;
      in UZ Leuven will be evaluated according to a psychosocial and neuropsychological protocol&#xD;
      including different psychological tests and patient questionaires.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 2014</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">April 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>18 Years</target_duration>
  <primary_outcome>
    <measure>Neuropsychological profile (questionnaires, neuropsychological testing) of children with myotonic dystonia type 1</measure>
    <time_frame>one year</time_frame>
    <description>Compare the outcome of the questionnaires, IQ test and other neuropsychological test to a normal population</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Neuromuscular Diseases</condition>
  <arm_group>
    <arm_group_label>Neuromuscular disease</arm_group_label>
    <description>Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        children and adolescents with neuromuscular disease&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  children and adolescents (0-18 years)&#xD;
&#xD;
          -  diagnosis of neuromuscular disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie Goemans, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Liesbeth De Waele, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZ Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sam Geuens, Master</last_name>
    <phone>+32 16 34 19 91</phone>
    <email>sam.geuens@uzleuven.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>sam Geuens</last_name>
      <email>sam.geuens@uzleuven.be</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2014</study_first_posted>
  <last_update_submitted>January 26, 2023</last_update_submitted>
  <last_update_submitted_qc>January 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 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>Neuromuscular Diseases</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/NCT02253290
org study id: S57182
nct id: NCT02253290
lead sponsor: 
has dmc: No
This project is a retrospective and prospective investigation of neuropsychological and
      psychosocial development of children with a neuromuscular disease.
This project is a retrospective and prospective investigation of neuropsychological and
      psychosocial development of children with a neuromuscular disease. Children and adolescents
      in UZ Leuven will be evaluated according to a psychosocial and neuropsychological protocol
      including different psychological tests and patient questionaires.
observational model: Cohort
time perspective: Other
measure: Neuropsychological profile (questionnaires, neuropsychological testing) of children with myotonic dystonia type 1
time frame: one year
description: Compare the outcome of the questionnaires, IQ test and other neuropsychological test to a normal population
arm group label: Neuromuscular disease
description: Children and adolescents with Neuromuscular disease children according to neuromuscular convention UZL
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: Nathalie Goemans, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven
last name: Liesbeth De Waele, MD, PhD
role: Principal Investigator
affiliation: UZ Leuven
last name: Sam Geuens, Master
phone: +32 16 34 19 91
email: sam.geuens@uzleuven.be
facility: 
status: Recruiting
contact: 
country: Belgium
responsible party type: Sponsor
mesh term: Neuromuscular Diseases