<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/NCT02193932</url>
  </required_header>
  <id_info>
    <org_study_id>12-100</org_study_id>
    <nct_id>NCT02193932</nct_id>
  </id_info>
  <brief_title>Electroencephalogram (EEG) Triggered Functional Magnetic Resonance Imaging (fMRI) in Epilepsy Patients</brief_title>
  <official_title>EEG-triggered fMRI in Epilepsy Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Baptist Health South Florida</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Baptist Health South Florida</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective exploratory study in patients with drug resistant epilepsy with a target&#xD;
      comparison of long term outcome. NeuroScan software modules and a MagLink will be used to&#xD;
      acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining&#xD;
      integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the&#xD;
      MRI machine, without compromising the raw EEG data.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 1, 2013</start_date>
  <completion_date type="Actual">July 30, 2019</completion_date>
  <primary_completion_date type="Actual">July 30, 2019</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>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with at least 40 interictal epileptic discharges during the fMRI</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">2</enrollment>
  <condition>Epilepsy</condition>
  <arm_group>
    <arm_group_label>EEG Triggered fMRI using Micro Maglink</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>EEG Triggered fMRI to be performed using the Micro Maglink</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>EEG Triggered fMRI using Micro Maglink</intervention_name>
    <arm_group_label>EEG Triggered fMRI using Micro Maglink</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Refractory epilepsy cases, referred by the service of Neurology. These are cases whose&#xD;
             pathophysiology is resistant to treatment, including change in medication and or added&#xD;
             medication.&#xD;
&#xD;
          2. Patients will be included if they agree to sign an Institutional Review Board approved&#xD;
             written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with overt symptoms or signs of anxiety than cannot cooperate during the&#xD;
             recording inside the scanner, unless consent is given for the procedure to be&#xD;
             performed with sedation by the anesthesia department.&#xD;
&#xD;
          2. Patients who meet the regular exclusion criteria for Magnetic Resonance Imaging (MRI)&#xD;
             studies per the prescreening form reviewed with all patients prior to exams&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sergio Gonzalez-Arias, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Baptist Health South Florida</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 16, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 18, 2014</study_first_posted>
  <last_update_submitted>September 19, 2019</last_update_submitted>
  <last_update_submitted_qc>September 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 20, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>EEG triggered</keyword>
  <keyword>fMRI</keyword>
  <keyword>epilepsy</keyword>
  <keyword>intractable</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</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/NCT02193932
org study id: 12-100
nct id: NCT02193932
lead sponsor: 
has dmc: No
A prospective exploratory study in patients with drug resistant epilepsy with a target
      comparison of long term outcome. NeuroScan software modules and a MagLink will be used to
      acquire EEG in combination with MRI/fMRI data. The MagLink system is used for obtaining
      integrated EEG and Event Related Potential (ERP) recordings while the subject is inside the
      MRI machine, without compromising the raw EEG data.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Number of participants with at least 40 interictal epileptic discharges during the fMRI
time frame: 1 year
arm group label: EEG Triggered fMRI using Micro Maglink
arm group type: Experimental
description: EEG Triggered fMRI to be performed using the Micro Maglink
intervention type: Other
intervention name: EEG Triggered fMRI using Micro Maglink
arm group label: EEG Triggered fMRI using Micro Maglink
criteria: 
gender: All
minimum age: 1 Year
maximum age: 75 Years
healthy volunteers: No
last name: Sergio Gonzalez-Arias, MD
role: Principal Investigator
affiliation: Baptist Health South Florida
facility: 
country: United States
responsible party type: Sponsor
mesh term: Epilepsy