<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/NCT04425798</url>
  </required_header>
  <id_info>
    <org_study_id>KY 2019-038-03</org_study_id>
    <nct_id>NCT04425798</nct_id>
  </id_info>
  <brief_title>Connectivity Alterations After Levetiracetam Application</brief_title>
  <official_title>Connectivity Alterations of Brain Network in LGG Patients After Levetiracetam Application at Short Term</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Neurosurgical Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Neurosurgical Institute</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aimed to analyze the connectivity alterations in brain networks of LGG patients&#xD;
      with epilepsy who take levetiracetam at short-term preoperatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas.&#xD;
      Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with&#xD;
      high-grade gliomas presented with GRE at the onset. Although beneficial for the control of&#xD;
      GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered&#xD;
      from seizures.&#xD;
&#xD;
      GRE was found to be associated with brain network and functional connectivity. And it has&#xD;
      been reported that temporal lobe seizures could induce functional connectivity and decreased&#xD;
      network efficiency of brain networks. However, the alterations in functional networks induced&#xD;
      by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV)&#xD;
      preoperatively, which could effectively reduce abnormal spike activity and further cause&#xD;
      connectivity alterations. This makes it more complex to reveal the connectivity alterations&#xD;
      of brain networks in LGG patients with GRE.&#xD;
&#xD;
      This study aimed to collect the resting-state functional MRIs of 30 LGG patients who&#xD;
      presented with GRE at the onset. Through further applied graph theory analysis, investigators&#xD;
      tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The&#xD;
      findings of this study will provide a theoretical basis for further study of connectivity&#xD;
      alterations of brain networks in patients with GRE.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">May 25, 2022</start_date>
  <completion_date type="Anticipated">September 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2022</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>The connectivity alterations of brain networks in patients with and without levetiracetam application</measure>
    <time_frame>through study completion, an average of 2 years</time_frame>
    <description>Graph theory analysis is used to delineate topological networks with resting-state functional MRIs and investigated the characteristics of functional networks. Global and nodal topological properties of brain networks are calculated in the two groups of patients. The difference of topological properties of brain networks between patients with and without levetiracetam application are analyzed using t-test or chi-square test according to the type of data.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Glioma</condition>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>Patients with LEV application</arm_group_label>
    <description>LGG patients with GRE take levetiracetam less than 1 month preoperatively. These patients take levetiracetam tablets twice a day, and one tablet at a time. Each levetiracetam tablet contains 500mg levetiracetam.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients without LEV application</arm_group_label>
    <description>LGG patients with GRE do not take any medicine or receive any treatment preoperatively.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with LGG presented GRE, take levetiracetam less than 1 month; or do not take&#xD;
        any medicine and receive any treatment.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years;&#xD;
&#xD;
          -  Histopathological diagnosis with LGG according to the 2016 World Health Organization&#xD;
             (WHO) criteria;&#xD;
&#xD;
          -  Participants received more than 6 years of school education;&#xD;
&#xD;
          -  Presence of GRE, take levetiracetam less than 1 month; or do not take any medicine and&#xD;
             receive any treatment;&#xD;
&#xD;
          -  No history of biopsy, radiotherapy, or chemotherapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for MRI;&#xD;
&#xD;
          -  Head motion greater than 3 mm in translation or 3° in rotation;&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Tao Jiang, MD and PhD</last_name>
    <phone>+86-010-67021832</phone>
    <email>taojiang1964@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lianwang Li, MD</last_name>
    <phone>+86 18810647541</phone>
    <email>ttyyllw@163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Neurosurgical Institute and Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100070</zip>
        <country>China</country>
      </address>
    </facility>
    <contact>
      <last_name>Tao Jiang, MD and PhD</last_name>
      <phone>+86-010-67021832</phone>
      <email>taojiang1964@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>June 7, 2020</last_update_submitted>
  <last_update_submitted_qc>June 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>glioma</keyword>
  <keyword>glioma-related epilepsy</keyword>
  <keyword>levetiracetam</keyword>
  <keyword>connectivity alteration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glioma</mesh_term>
    <mesh_term>Epilepsy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>We do not plan to share individual participant data with other researchers</ipd_description>
  </patient_data>
  <!-- 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/NCT04425798
org study id: KY 2019-038-03
nct id: NCT04425798
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aimed to analyze the connectivity alterations in brain networks of LGG patients
      with epilepsy who take levetiracetam at short-term preoperatively.
Glioma-related epilepsy (GRE) is a very common symptom in patients with diffuse gliomas.
      Approximately 60% of patients with low-grade gliomas (LGGs) and 40-64% of patients with
      high-grade gliomas presented with GRE at the onset. Although beneficial for the control of
      GRE, the overall therapeutic effect was unsatisfied and over 20% of patients still suffered
      from seizures.

      GRE was found to be associated with brain network and functional connectivity. And it has
      been reported that temporal lobe seizures could induce functional connectivity and decreased
      network efficiency of brain networks. However, the alterations in functional networks induced
      by GRE were still unclear. And LGG patients with GRE usually take levetiracetam (LEV)
      preoperatively, which could effectively reduce abnormal spike activity and further cause
      connectivity alterations. This makes it more complex to reveal the connectivity alterations
      of brain networks in LGG patients with GRE.

      This study aimed to collect the resting-state functional MRIs of 30 LGG patients who
      presented with GRE at the onset. Through further applied graph theory analysis, investigators
      tend to reveal the connectivity alterations of brain networks caused by levetiracetam. The
      findings of this study will provide a theoretical basis for further study of connectivity
      alterations of brain networks in patients with GRE.
observational model: Case-Control
time perspective: Prospective
measure: The connectivity alterations of brain networks in patients with and without levetiracetam application
time frame: through study completion, an average of 2 years
description: Graph theory analysis is used to delineate topological networks with resting-state functional MRIs and investigated the characteristics of functional networks. Global and nodal topological properties of brain networks are calculated in the two groups of patients. The difference of topological properties of brain networks between patients with and without levetiracetam application are analyzed using t-test or chi-square test according to the type of data.
arm group label: Patients with LEV application
description: LGG patients with GRE take levetiracetam less than 1 month preoperatively. These patients take levetiracetam tablets twice a day, and one tablet at a time. Each levetiracetam tablet contains 500mg levetiracetam.
arm group label: Patients without LEV application
description: LGG patients with GRE do not take any medicine or receive any treatment preoperatively.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Tao Jiang, MD and PhD
phone: +86-010-67021832
email: taojiang1964@163.com
last name: Lianwang Li, MD
phone: +86 18810647541
email: ttyyllw@163.com
facility: 
contact: 
country: China
responsible party type: Sponsor
mesh term: Glioma
mesh term: Epilepsy
sharing ipd: No
ipd description: We do not plan to share individual participant data with other researchers