xml: <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/NCT05989893</url>
    </required_header>
    <id_info>
      <org_study_id>HSC-MS-06-0385</org_study_id>
      <secondary_id>U01NS128921</secondary_id>
      <nct_id>NCT05989893</nct_id>
    </id_info>
    <brief_title>The Neural Code and Dynamics of the Reading Network.</brief_title>
    <official_title>Comparative Analysis of Structural and Functional Characteristics of Brain Regions Measured by Functional Imaging AND Electrophysiology and Hemispheric Laterality Predicted by Structural Connectivity and Fronto-basal-ganglia Circuits for Selective Stopping and Braking and Diffusion Imaging for Seizure Focus Localization AND Representation and Binding of Spatial and Temporal Episodic Memories in Human Hippocampus AND Sparsity and Spectral-Temporal Decomposition in Real-Time Network Modulation for Intractable Epilepsy AND Neural Basis of Human Spatial Navigation AND Mapping Brain Regions of Mood</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>The University of Texas Health Science Center, Houston</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>The University of Texas Health Science Center, Houston</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>
        The purpose of this study is to compare organization of normal brain function as detected&#xD;
        using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients&#xD;
        with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas)&#xD;
        and functional significance to each region involved in cognitive processes as detected by&#xD;
        cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or&#xD;
        depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a&#xD;
        population of patients without overt structural abnormalities in these regions, to generate a&#xD;
        spatial probability map of locations of cortical regions &quot;essential&quot; for these processes, to&#xD;
        compare the loci of &quot;crucial&quot; language, visual, motor and cognitive sites as determined by&#xD;
        CSM with the loci determined by a battery of tasks using fMRI for each individual and to use&#xD;
        these data in patients undergoing intracranial electro-corticographyto determine the loci of&#xD;
        essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses&#xD;
        of these intracranial recordings to study information flow between these areas.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 10, 2022</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2027</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in reading errors as assessed by the number of words read incorrectly</measure>
      <time_frame>Baseline, during stimulation( about 2 seconds after baseline )</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in reaction times in milliseconds</measure>
      <time_frame>Baseline, during stimulation( about 2 seconds after baseline )</time_frame>
      <description>reaction time is the time it takes to say the word after seeing it</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">75</enrollment>
    <condition>Epilepsy</condition>
    <condition>Brain Tumor</condition>
    <arm_group>
      <arm_group_label>Neural recordings and stimulation during language tasks</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Language-based tasks</intervention_name>
      <description>In either the MRI suite, or the Epilepsy Monitoring Unit, or the operating room, epilepsy and tumor subjects are asked to perform a variety of language-based tasks as neural recordings are made from and/or neural stimulations are delivered to various language areas of the brain.</description>
      <arm_group_label>Neural recordings and stimulation during language tasks</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with medically refractory epilepsy who are scheduled to undergo or have&#xD;
               previously undergone placement of sub-dural electrodes (including depth electrodes) to&#xD;
               localize the site of seizure onset and to map the locations of critical language and&#xD;
               motor regions&#xD;
  &#xD;
            -  patients with epilepsy, brain tumors or cortically based vascular malformations&#xD;
               (cavernous malformations or arterio-venous malformations) with lesions that are/were&#xD;
               proximate to crucial brain regions, and who are scheduled to undergo or have&#xD;
               previously undergone intra-op mapping of motor, visual or language function, or a Wada&#xD;
               test, or maybe part of an awake craniotomy.&#xD;
  &#xD;
            -  proficiency in English&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Gross structural abnormalities (large hamartomata, tumors, large vascular&#xD;
               malformations, very large diffuse malformations of cortical development) that may have&#xD;
               impacted upon the location of critical brain areas.&#xD;
  &#xD;
            -  Unable to participate in testing due to impaired cognition or mental retardation.&#xD;
  &#xD;
            -  Cardiac pacemakers, intracranial aneurysm clips, or other potentially mobile implanted&#xD;
               metallic devices&#xD;
  &#xD;
            -  Patients with claustrophobia who cannot undergo an MRI scan without sedation&#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_official>
      <last_name>Nitin Tandon, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>The University of Texas Health Science Center, Houston</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nitin Tandon, MD</last_name>
      <phone>713-500-5456</phone>
      <email>Nitin.Tandon@uth.tmc.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Eliana M Klier</last_name>
      <phone>713-500-5442</phone>
      <email>Eliana.Klier@uth.tmc.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>The University of Texas Health Science Center at Houston</name>
        <address>
          <city>Houston</city>
          <state>Texas</state>
          <zip>77479</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nitin Tandon, MD</last_name>
        <phone>713-500-5456</phone>
        <email>Nitin.Tandon@uth.tmc.edu</email>
      </contact>
      <contact_backup>
        <last_name>Eliana M Klier</last_name>
        <phone>713-500-5442</phone>
        <email>Eliana.Klier@uth.tmc.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>The University of Texas Health Science Center, Houston</investigator_affiliation>
      <investigator_full_name>Nitin Tandon</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>seizure</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Epilepsy</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989893
  org study id: HSC-MS-06-0385
  secondary id: U01NS128921
  nct id: NCT05989893
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to compare organization of normal brain function as detected
        using Functional magnetic resonance imaging (fMRI) in normal subjects as opposed to patients
        with epilepsy or brain tumors, to ascribe precise anatomic labels (including Brodmann Areas)
        and functional significance to each region involved in cognitive processes as detected by
        cortical stimulation mapping (CSM) in patients with implanted subdural electrodes (SDE) or
        depth (sEEG) electrodes, to describe the locations of these regions in Talairach space, for a
        population of patients without overt structural abnormalities in these regions, to generate a
        spatial probability map of locations of cortical regions "essential" for these processes, to
        compare the loci of "crucial" language, visual, motor and cognitive sites as determined by
        CSM with the loci determined by a battery of tasks using fMRI for each individual and to use
        these data in patients undergoing intracranial electro-corticographyto determine the loci of
        essential, involved and uninvolved brain areas, and use sophisticated mathematical analyses
        of these intracranial recordings to study information flow between these areas.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Change in reading errors as assessed by the number of words read incorrectly
  time frame: Baseline, during stimulation( about 2 seconds after baseline )
  measure: Change in reaction times in milliseconds
  time frame: Baseline, during stimulation( about 2 seconds after baseline )
  description: reaction time is the time it takes to say the word after seeing it
  arm group label: Neural recordings and stimulation during language tasks
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: Language-based tasks
  description: In either the MRI suite, or the Epilepsy Monitoring Unit, or the operating room, epilepsy and tumor subjects are asked to perform a variety of language-based tasks as neural recordings are made from and/or neural stimulations are delivered to various language areas of the brain.
  arm group label: Neural recordings and stimulation during language tasks
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Nitin Tandon, MD
  role: Principal Investigator
  affiliation: The University of Texas Health Science Center, Houston
  last name: Nitin Tandon, MD
  phone: 713-500-5456
  email: Nitin.Tandon@uth.tmc.edu
  last name: Eliana M Klier
  phone: 713-500-5442
  email: Eliana.Klier@uth.tmc.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: The University of Texas Health Science Center, Houston
  investigator full name: Nitin Tandon
  investigator title: Professor
  mesh term: Epilepsy
  sharing ipd: No