<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/NCT03010826</url>
  </required_header>
  <id_info>
    <org_study_id>1000053920</org_study_id>
    <nct_id>NCT03010826</nct_id>
  </id_info>
  <brief_title>Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children</brief_title>
  <official_title>Pharmacological Recruitment of Endogenous Neural Precursors to Promote Pediatric White Matter Repair: Establishing Correlations Between Visual Outcomes, Saccadic Function and MEG Oscillations in Children With Demyelinating Disorders in Comparison to Healthy Control Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Hospital for Sick Children</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Hospital for Sick Children</source>
  <brief_summary>
    <textblock>
      The neural circuits in our brains require a layer of insulation in order to transmit signals&#xD;
      in a rapid and efficient fashion. This insulation is called White Matter and is comprised of&#xD;
      a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs&#xD;
      following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and&#xD;
      cognitive problems. Currently there are no effective medical therapies to promote brain&#xD;
      repair and reduce disability following damage to white matter. In this project, we hope to&#xD;
      change the situation by encouraging the brain itself to generate new oligodendrocytes and&#xD;
      thus new white matter. Our first step is to find measures sensitive to white matter growth.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">November 16, 2018</completion_date>
  <primary_completion_date type="Actual">November 16, 2018</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>Neuronal responses during pro/anti-saccade eye movements</measure>
    <time_frame>60 minutes</time_frame>
    <description>Video-based eye tracking monocularly in the MEG and binocularly outside the MEG</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Electrical potentials initiated by brief visual stimuli</measure>
    <time_frame>10 minutes</time_frame>
    <description>Visual Evoked Potentials (VEP)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MRI scans of the brain, including Diffusion Tensor Imagine (DTI)</measure>
    <time_frame>90 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurocognitive Testing</measure>
    <time_frame>90 minutes</time_frame>
    <description>Computerized Penn Neurocognitive Battery</description>
  </primary_outcome>
  <primary_outcome>
    <measure>High contrast visual acuity</measure>
    <time_frame>10 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Low contrast visual acuity; colour vision; visual fields testing; OCT testing;</measure>
    <time_frame>10 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Colour vision testing</measure>
    <time_frame>10 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual fields testing</measure>
    <time_frame>20 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Optical coherence tomography (OCT)</measure>
    <time_frame>25 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.</measure>
    <time_frame>20 minutes</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Clinical Interview</measure>
    <time_frame>10 minutes</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">78</enrollment>
  <condition>Demyelinating Disease</condition>
  <arm_group>
    <arm_group_label>40 Demyelinating Disease patients</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>40 Non-patient participants</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        There will be a total of 80 participants in this study. The study population consists of&#xD;
        both patients (demyelinating disease) and non-patient participants (healthy volunteers).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Experienced a demyelinating event (Only applicable to patient subjects)&#xD;
&#xD;
          -  Between the ages of 5 years to 18 years and 11 months of age&#xD;
&#xD;
          -  Has either English as his or her native language or has had at least two years of&#xD;
             schooling in English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children with non-demyelinating etiologies of white matter dysfunction (i.e.,&#xD;
             metabolic disorders, vasculitis, and non-specific MRI abnormalities&#xD;
&#xD;
          -  Is younger than 5 years of age&#xD;
&#xD;
          -  Is 18 years and 11 of age or older&#xD;
&#xD;
          -  Has a prior history of traumatic brain injury, neurological disorder, cerebral palsy,&#xD;
             developmental delay, or learning disability&#xD;
&#xD;
          -  Requires sedation for brain scanning&#xD;
&#xD;
          -  Is claustrophobic, as brain scanning requires children to enter a tunnel in the MRI&#xD;
             machine&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Queen's University</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 3N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital for Sick Children</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G1X8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>January 6, 2020</last_update_submitted>
  <last_update_submitted_qc>January 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Hospital for Sick Children</investigator_affiliation>
    <investigator_full_name>E. Ann Yeh</investigator_full_name>
    <investigator_title>Associate Scientist, Research Institute</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Demyelinating 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/NCT03010826
org study id: 1000053920
nct id: NCT03010826
lead sponsor: 
The neural circuits in our brains require a layer of insulation in order to transmit signals
      in a rapid and efficient fashion. This insulation is called White Matter and is comprised of
      a specific type of brain cell called an oligodendrocytes. Damage to brain white matter occurs
      following injury and in disorders like Multiple Sclerosis and results in sensory, motor, and
      cognitive problems. Currently there are no effective medical therapies to promote brain
      repair and reduce disability following damage to white matter. In this project, we hope to
      change the situation by encouraging the brain itself to generate new oligodendrocytes and
      thus new white matter. Our first step is to find measures sensitive to white matter growth.
observational model: Case-Control
time perspective: Prospective
measure: Neuronal responses during pro/anti-saccade eye movements
time frame: 60 minutes
description: Video-based eye tracking monocularly in the MEG and binocularly outside the MEG
measure: Electrical potentials initiated by brief visual stimuli
time frame: 10 minutes
description: Visual Evoked Potentials (VEP)
measure: MRI scans of the brain, including Diffusion Tensor Imagine (DTI)
time frame: 90 minutes
measure: Neurocognitive Testing
time frame: 90 minutes
description: Computerized Penn Neurocognitive Battery
measure: High contrast visual acuity
time frame: 10 minutes
measure: Low contrast visual acuity; colour vision; visual fields testing; OCT testing;
time frame: 10 minutes
measure: Colour vision testing
time frame: 10 minutes
measure: Visual fields testing
time frame: 20 minutes
measure: Optical coherence tomography (OCT)
time frame: 25 minutes
measure: Neurological Exam - Standard physical exam performed by neurologist to determine the Expanded Disability Status Scale (EDSS) score.
time frame: 20 minutes
measure: Clinical Interview
time frame: 10 minutes
arm group label: 40 Demyelinating Disease patients
arm group label: 40 Non-patient participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 5 Years
maximum age: 18 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: The Hospital for Sick Children
investigator full name: E. Ann Yeh
investigator title: Associate Scientist, Research Institute
mesh term: Demyelinating Diseases