<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/NCT03819738</url>
  </required_header>
  <id_info>
    <org_study_id>S60058</org_study_id>
    <nct_id>NCT03819738</nct_id>
  </id_info>
  <brief_title>fMRI in Deep Brain Stimulation</brief_title>
  <official_title>Functional Magnetic Resonance Imaging in Deep Brain Stimulation</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      With fMRI, we want to understand the mechanisms of brain neuromodulation in (dys)functional&#xD;
      brain circuits, to obtain knowledge on involved brain networks in DBS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Deep brain stimulation represents a neurosurgical treatment option for specific refractory&#xD;
      neurological and psychiatric disorders. In these patients a specific brain target is&#xD;
      stimulated through an electrode with the use of an implantable pulse generator (IPG). In a&#xD;
      functional MRI (fMRI) experiment, the investigators intend to perform imaging during&#xD;
      stimulation ON and compare brain activations with the stimulation OFF condition. In this way,&#xD;
      they aim to elucidate the involved brain network in deep brain stimulation. Since the&#xD;
      connectivity of deep brain structures is complex, different activation patterns are expected&#xD;
      in-between subjects and conditions. If specific activation patterns during the stimulation ON&#xD;
      condition can be related to treatment response, this is of important clinical value. These&#xD;
      findings can lead to an optimization of the deep brain target or even to different useful&#xD;
      targets for brain stimulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 24, 2017</start_date>
  <completion_date type="Anticipated">January 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 10, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>For each subject, condition effects will be estimated using the general linear model</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Determine the functional networks that are involved in DBS</measure>
    <time_frame>5 years</time_frame>
    <description>To determine differences in activations of functional networks between ON and OFF DBS in an fMRI experiment,</description>
  </primary_outcome>
  <primary_outcome>
    <measure>To link the involved network to outcome in DBS therapy</measure>
    <time_frame>5 years</time_frame>
    <description>To link specific activation patterns during ON-OFF with a clinical value</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Epilepsy</condition>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>fMRI intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>fMRI</intervention_name>
    <description>Functional MRI will be performed in 1 scan, which will take 1.5 h. (scanning time = 30 min)</description>
    <arm_group_label>fMRI intervention</arm_group_label>
    <other_name>DBS</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Deep brain stimulation system implanted&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children and pregnant women will be excluded. Failure to follow to protocol is also an&#xD;
             exclusion criterion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tom Theys, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitaire Ziekenhuizen KU Leuven</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tom Theys, PhD</last_name>
    <phone>016344241</phone>
    <email>tom.theys@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Peter Janssen, PhD</last_name>
    <phone>016330669</phone>
    <email>peter.janssen@med.kuleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZLeuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fMRI</keyword>
  <keyword>epilepsy</keyword>
  <keyword>pain</keyword>
  <keyword>electrode</keyword>
  <keyword>brain</keyword>
  <keyword>neuromodulation</keyword>
  <keyword>DBS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Chronic Pain</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/NCT03819738
org study id: S60058
nct id: NCT03819738
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
With fMRI, we want to understand the mechanisms of brain neuromodulation in (dys)functional
      brain circuits, to obtain knowledge on involved brain networks in DBS.
Deep brain stimulation represents a neurosurgical treatment option for specific refractory
      neurological and psychiatric disorders. In these patients a specific brain target is
      stimulated through an electrode with the use of an implantable pulse generator (IPG). In a
      functional MRI (fMRI) experiment, the investigators intend to perform imaging during
      stimulation ON and compare brain activations with the stimulation OFF condition. In this way,
      they aim to elucidate the involved brain network in deep brain stimulation. Since the
      connectivity of deep brain structures is complex, different activation patterns are expected
      in-between subjects and conditions. If specific activation patterns during the stimulation ON
      condition can be related to treatment response, this is of important clinical value. These
      findings can lead to an optimization of the deep brain target or even to different useful
      targets for brain stimulation.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: For each subject, condition effects will be estimated using the general linear model
primary purpose: Health Services Research
masking: None (Open Label)
measure: Determine the functional networks that are involved in DBS
time frame: 5 years
description: To determine differences in activations of functional networks between ON and OFF DBS in an fMRI experiment,
measure: To link the involved network to outcome in DBS therapy
time frame: 5 years
description: To link specific activation patterns during ON-OFF with a clinical value
arm group label: fMRI intervention
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: fMRI
description: Functional MRI will be performed in 1 scan, which will take 1.5 h. (scanning time = 30 min)
arm group label: fMRI intervention
other name: DBS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tom Theys, PhD
role: Principal Investigator
affiliation: Universitaire Ziekenhuizen KU Leuven
last name: Tom Theys, PhD
phone: 016344241
email: tom.theys@uzleuven.be
last name: Peter Janssen, PhD
phone: 016330669
email: peter.janssen@med.kuleuven.be
facility: 
status: Recruiting
country: Belgium
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Chronic Pain