<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/NCT01730274</url>
  </required_header>
  <id_info>
    <org_study_id>cerebellum 1.1</org_study_id>
    <secondary_id>KLI 252</secondary_id>
    <nct_id>NCT01730274</nct_id>
  </id_info>
  <brief_title>Cerebellum - Cognitive Outcome and Functional Connectivity</brief_title>
  <official_title>Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional&#xD;
      connectivity level in higher order cognition networks known to interact with the cerebellum.&#xD;
      Furthermore, to correlate the connectivity level of these networks with the&#xD;
      neuropsychological performance and functional outcome of the patients.&#xD;
&#xD;
      The investigator's hypothesis is that the functional connectivity of various cognition&#xD;
      networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging&#xD;
      can be impaired after cerebellar tumor surgery and can be correlated with the&#xD;
      neuropsychological performance. The effect of surgery on the cognition networks and the&#xD;
      neuropsychological performance is dependent on the tumor location within the cerebellum. Such&#xD;
      a correlation seems feasible as functional connectivity analysis could be correlated with the&#xD;
      neuropsychological impairment in various neuropsychiatric disorders. Furthermore,&#xD;
      investigators were able to depict the maturation of the functional connectivity networks in&#xD;
      parallel to the neurocognitive development in childhood&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">September 2014</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>neuropsychological assessment</measure>
    <time_frame>up to 24 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Childhood Cerebellar Tumor</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <description>children operated on a cerebellar tumor</description>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy subjects</arm_group_label>
    <description>healthy volunteers</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        young adolescent operated on a cerebellar tumor as a child&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Male or female patients aged &gt; 15 yrs&#xD;
&#xD;
               -  Age at surgery between 1 yrs - 12 yrs&#xD;
&#xD;
               -  Compliance (the patients have to be able to lay motionless in a 3 Tesla MR&#xD;
                  scanner and to cooperate with the examiner during the examination)&#xD;
&#xD;
               -  Signed informed consent from the patient and/or the parents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients with Neurofibromatosis 1&#xD;
&#xD;
               -  Severe visual or auditory impairment&#xD;
&#xD;
               -  Cerebrospinal fluid shunt device&#xD;
&#xD;
               -  Prior radiotherapy or chemotherapy&#xD;
&#xD;
               -  Contraindications to MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian Dorfer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>MUV, Department of Neurosurgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>MUV, Department of Neurosurgery</name>
      <address>
        <city>Vienna</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Christian Dorfer</investigator_full_name>
    <investigator_title>Dr.med.univ.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebellar Neoplasms</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/NCT01730274
org study id: cerebellum 1.1
secondary id: KLI 252
nct id: NCT01730274
lead sponsor: 
has dmc: No
Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional
      connectivity level in higher order cognition networks known to interact with the cerebellum.
      Furthermore, to correlate the connectivity level of these networks with the
      neuropsychological performance and functional outcome of the patients.

      The investigator's hypothesis is that the functional connectivity of various cognition
      networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging
      can be impaired after cerebellar tumor surgery and can be correlated with the
      neuropsychological performance. The effect of surgery on the cognition networks and the
      neuropsychological performance is dependent on the tumor location within the cerebellum. Such
      a correlation seems feasible as functional connectivity analysis could be correlated with the
      neuropsychological impairment in various neuropsychiatric disorders. Furthermore,
      investigators were able to depict the maturation of the functional connectivity networks in
      parallel to the neurocognitive development in childhood
observational model: Case-Control
time perspective: Prospective
measure: neuropsychological assessment
time frame: up to 24 months
arm group label: patients
description: children operated on a cerebellar tumor
arm group label: healthy subjects
description: healthy volunteers
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 15 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Christian Dorfer, MD
role: Principal Investigator
affiliation: MUV, Department of Neurosurgery
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Christian Dorfer
investigator title: Dr.med.univ.
mesh term: Cerebellar Neoplasms