<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/NCT03265925</url>
  </required_header>
  <id_info>
    <org_study_id>ELM-40</org_study_id>
    <nct_id>NCT03265925</nct_id>
  </id_info>
  <brief_title>Brain Network Activation Analysis in Epilepsy</brief_title>
  <official_title>Brain Network Activation Analysis in Epilepsy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ElMindA Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ElMindA Ltd</source>
  <brief_summary>
    <textblock>
      This is a prospective study investigating the utility of Brain Network Activation (BNA)&#xD;
      analysis in patients with epilepsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BNA technology is based on a network model to depict functional connectivity. The descriptive&#xD;
      network model approach provides insights regarding inter-connectivity of brain networks and&#xD;
      can describe the temporal-spatial brain activation patterns applied to various types of&#xD;
      data-sets including EEG, MEG and fMRI.&#xD;
&#xD;
      In this study it is proposed that synchronization in brain activity may be disrupted in&#xD;
      patients who experience frequent seizures and may correspond to functional impairments (e.g.,&#xD;
      memory, processing speed). As such, BNA analysis may provide additional data that complement&#xD;
      current functional assessments, inform clinical assessment and management of epilepsy, and&#xD;
      identify subgroups of patients that might be at risk for poor treatment outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 26, 2017</start_date>
  <completion_date type="Actual">May 8, 2018</completion_date>
  <primary_completion_date type="Actual">May 8, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assess the BNA database for Epilepsy population and healthy controls.</measure>
    <time_frame>Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable.</time_frame>
    <description>Functional networks of brain activity in Epilepsy (Right and Left lobe) and healthy control individuals measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Epilepsy pathology and healthy controls.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">1</enrollment>
  <condition>Epilepsy</condition>
  <condition>Epilepsy, Temporal Lobe</condition>
  <arm_group>
    <arm_group_label>Epilepsy patients Right Temporal Lobe</arm_group_label>
    <description>Epilepsy patients with seizures originating from the right temporal lobe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Epilepsy patients Left Temporal Lobe</arm_group_label>
    <description>Epilepsy patients with seizures originating from the left temporal lobe</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <description>Healthy controls</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Participants will be recruited from the long-term EEG monitoring floor and outpatient EEG&#xD;
        laboratory. Controls will be recruited in response to advertisements. All participants will&#xD;
        be given the BNA Auditory Go/NoGo task. Patient identity will be coded with a master record&#xD;
        kept on a password protected computer in the laboratory. Deidentified data will be sent to&#xD;
        ElMindA for scoring of the BNA test. Patient data from electronic medical records will be&#xD;
        extracted along with patient MRI data processed.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants will be between ages 18-50 years old&#xD;
&#xD;
          -  Able to speak, read and understand English sufficiently to understand the nature of&#xD;
             the study, and to allow completion of all study assessments&#xD;
&#xD;
          -  Willingness to participate and able to give informed consent&#xD;
&#xD;
          -  If corrected vision: only Glasses should be used during the study testing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of significant head trauma&#xD;
&#xD;
          -  Evidence of other neurologic disease&#xD;
&#xD;
          -  Any diagnosed psychiatric or systemic condition that could lead to a change in brain&#xD;
             activity or volume (e.g., stroke, Alzheimer's disease, alcoholism).&#xD;
&#xD;
          -  Currently with lice or open wounds on scalp&#xD;
&#xD;
          -  Significant sensory deficits&#xD;
&#xD;
          -  Use of a hearing aid that occupies the ear canal&#xD;
&#xD;
          -  Substance abuse in the last 3 months and any clinically significant substance&#xD;
             dependency&#xD;
&#xD;
          -  Additional exclusion criteria for controls are a history of any neurological disease&#xD;
             or psychological illness.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Travis Stoub, PhD</last_name>
    <role>Principal Investigator</role>
  </overall_official>
  <location>
    <facility>
      <name>RUSH University medical center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>September 26, 2018</last_update_submitted>
  <last_update_submitted_qc>September 26, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 27, 2018</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>Epilepsy</mesh_term>
    <mesh_term>Epilepsy, Temporal Lobe</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/NCT03265925
org study id: ELM-40
nct id: NCT03265925
lead sponsor: 
This is a prospective study investigating the utility of Brain Network Activation (BNA)
      analysis in patients with epilepsy.
BNA technology is based on a network model to depict functional connectivity. The descriptive
      network model approach provides insights regarding inter-connectivity of brain networks and
      can describe the temporal-spatial brain activation patterns applied to various types of
      data-sets including EEG, MEG and fMRI.

      In this study it is proposed that synchronization in brain activity may be disrupted in
      patients who experience frequent seizures and may correspond to functional impairments (e.g.,
      memory, processing speed). As such, BNA analysis may provide additional data that complement
      current functional assessments, inform clinical assessment and management of epilepsy, and
      identify subgroups of patients that might be at risk for poor treatment outcomes.
observational model: Cohort
time perspective: Prospective
measure: Assess the BNA database for Epilepsy population and healthy controls.
time frame: Epilepsy subjects will perform the BNA testing at baseline prior to change in medication if applicable and 3-10 days following change in medication when applicable.
description: Functional networks of brain activity in Epilepsy (Right and Left lobe) and healthy control individuals measured using analysis of EEG Event Related Potential (ERP) data. Clinical assessments battery will be utilized in order to examine different sets of BNA database for Epilepsy pathology and healthy controls.
arm group label: Epilepsy patients Right Temporal Lobe
description: Epilepsy patients with seizures originating from the right temporal lobe
arm group label: Epilepsy patients Left Temporal Lobe
description: Epilepsy patients with seizures originating from the left temporal lobe
arm group label: Healthy
description: Healthy controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Travis Stoub, PhD
role: Principal Investigator
facility: 
country: United States
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Epilepsy, Temporal Lobe