<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/NCT04464473</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00000532</org_study_id>
    <secondary_id>R01MH121509</secondary_id>
    <nct_id>NCT04464473</nct_id>
  </id_info>
  <brief_title>cTBS/fMRI Study of Hierarchical Control in the PFC</brief_title>
  <official_title>cTBS/fMRI Study of Hierarchical Control in the PFC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Florida State University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Mental Health (NIMH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Florida State University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to examine the effect of transcranial magnetic stimulation&#xD;
      (TMS) on the prefrontal cortex and posterior parietal cortex.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Comprehensive Control Task (CCT) was designed to examine hierarchical control in a&#xD;
      single, well-controlled factorial task. On each trial, participants view a letter surrounded&#xD;
      by a colored shape at a particular screen location. Color cues the relevant feature, letter&#xD;
      or location, for a block of trials. The first trial of a block requires a decision of whether&#xD;
      the stimulus is the first position of a circular sequence (sequence start). Subsequent trials&#xD;
      require a decision of whether the viewed stimulus follows the previous stimulus in a circular&#xD;
      sequence (sequence 1-back). The letter sequence (C-O-M-I-C) and spatial sequence (Top&#xD;
      Left-Top Right-Bottom Left-Bottom Right-Top Left) are difficulty-matched.&#xD;
&#xD;
      Shape cues the task to perform. Squares indicate the standard baseline task, and each block&#xD;
      begins and ends with baseline trials. Different shapes indicate sub-tasks. In Switching&#xD;
      blocks, shape-switches (e.g. from square to circle or circle to square) cue the sequence&#xD;
      start task. Shape-repeats cue the sequence 1-back task. In Planning blocks, triangle shapes&#xD;
      indicate that the stimulus can be ignored (automatic &quot;no&quot; response). All the while, the last&#xD;
      square-shaped stimulus must be retained as a reference for the next square-shaped stimulus.&#xD;
      Finally, in Dual blocks, diamond shapes indicate switching (sequence start) and also&#xD;
      planning. The reversion back to square shapes requires sequence matching to the distal,&#xD;
      previous square.&#xD;
&#xD;
      The design is factorial with stimulus-domain x contextual control x temporal control&#xD;
      orthogonally manipulated. Full details of the CCT have been previous described in Nee &amp;&#xD;
      D'Esposito, 2016; 2017.&#xD;
&#xD;
      The focus in this study will be comparison of FPl-TMS, MFG-TMS, and S1-TMS in an interleaved&#xD;
      fMRI-TMS-fMRI design. The logic is to test the apical status of the FPl/MFG through the&#xD;
      extent to which TMS impacts other PFC areas and behavior.&#xD;
&#xD;
      Each experiment will begin with 1 session of the CCT with fMRI to localize PFC targets. Each&#xD;
      participant will then perform 3 counter-balanced sessions wherein a different site will be&#xD;
      targeted by TMS followed immediately by fMRI on the CCT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 23, 2021</start_date>
  <completion_date type="Anticipated">July 14, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PFC-PPC effective connectivity</measure>
    <time_frame>baseline, pre-intervention and immediately after intervention</time_frame>
    <description>effective connectivity among areas of the prefrontal and posterior parietal cortex in the blood oxygenation level dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) [note, this measure has no units]</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PFC-PPC activation</measure>
    <time_frame>baseline, pre-intervention and immediately after intervention</time_frame>
    <description>blood oxygenation level dependent (BOLD) signal in areas of the prefrontal and posterior parietal cortex assessed with functional magnetic resonance imaging (fMRI) [note, this measure has no units]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>temporal control performance</measure>
    <time_frame>baseline, pre-intervention and immediately after intervention</time_frame>
    <description>behavioral performance (reaction time in milliseconds, and percent correct) on conditions involving temporal control in the comprehensive control task</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>contextual control performance</measure>
    <time_frame>baseline, pre-intervention and immediately after intervention</time_frame>
    <description>behavioral performance (reaction time in milliseconds, and percent correct) on conditions involving contextual control in the comprehensive control task</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Transcranial Magnetic Stimulation</condition>
  <arm_group>
    <arm_group_label>FPl-TMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial magnetic stimulation to the lateral frontal pole. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MFG-TMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..</description>
  </arm_group>
  <arm_group>
    <arm_group_label>S1-TMS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transcranial magnetic stimulation to primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial magnetic stimulation</intervention_name>
    <description>Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.</description>
    <arm_group_label>FPl-TMS</arm_group_label>
    <arm_group_label>MFG-TMS</arm_group_label>
    <arm_group_label>S1-TMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between the ages of 18 and 30&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Native English speaker or fluent by the age of 6&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of psychiatric disorders&#xD;
&#xD;
          -  History of neurological disorders&#xD;
&#xD;
          -  Receiving medications for psychiatric or neurological disorders&#xD;
&#xD;
          -  Familial history of epilepsy&#xD;
&#xD;
          -  Taking any drugs or medications that are pro-epileptic&#xD;
&#xD;
          -  Metal anywhere in the head excluding the mouth&#xD;
&#xD;
          -  Tinnitus&#xD;
&#xD;
          -  Women who are pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Derek E Nee, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Florida State University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gabriella T Vill, BA</last_name>
    <phone>850-645-4066</phone>
    <email>vill@psy.fsu.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Florida State University Psychology Department Building</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32303</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Gabriella T Vill, BA</last_name>
      <phone>850-645-4066</phone>
      <email>vill@psy.fsu.edu</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>FSU MRI Facility</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32306</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Alecia Lapointe, MA</last_name>
      <phone>850-644-1889</phone>
      <email>alecia.lapointe@med.fsu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>December 28, 2022</last_update_submitted>
  <last_update_submitted_qc>December 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Florida State University</investigator_affiliation>
    <investigator_full_name>Derek Nee</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Behavioral and imaging data will be shared</ipd_description>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Within a year following publication of findings</ipd_time_frame>
    <ipd_access_criteria>Behavioral and imaging data will be accessible from https://nda.nih.gov/edit_collection.html?id=3448 by NDA users.</ipd_access_criteria>
  </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/NCT04464473
org study id: STUDY00000532
secondary id: R01MH121509
nct id: NCT04464473
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
The objective of this study is to examine the effect of transcranial magnetic stimulation
      (TMS) on the prefrontal cortex and posterior parietal cortex.
The Comprehensive Control Task (CCT) was designed to examine hierarchical control in a
      single, well-controlled factorial task. On each trial, participants view a letter surrounded
      by a colored shape at a particular screen location. Color cues the relevant feature, letter
      or location, for a block of trials. The first trial of a block requires a decision of whether
      the stimulus is the first position of a circular sequence (sequence start). Subsequent trials
      require a decision of whether the viewed stimulus follows the previous stimulus in a circular
      sequence (sequence 1-back). The letter sequence (C-O-M-I-C) and spatial sequence (Top
      Left-Top Right-Bottom Left-Bottom Right-Top Left) are difficulty-matched.

      Shape cues the task to perform. Squares indicate the standard baseline task, and each block
      begins and ends with baseline trials. Different shapes indicate sub-tasks. In Switching
      blocks, shape-switches (e.g. from square to circle or circle to square) cue the sequence
      start task. Shape-repeats cue the sequence 1-back task. In Planning blocks, triangle shapes
      indicate that the stimulus can be ignored (automatic "no" response). All the while, the last
      square-shaped stimulus must be retained as a reference for the next square-shaped stimulus.
      Finally, in Dual blocks, diamond shapes indicate switching (sequence start) and also
      planning. The reversion back to square shapes requires sequence matching to the distal,
      previous square.

      The design is factorial with stimulus-domain x contextual control x temporal control
      orthogonally manipulated. Full details of the CCT have been previous described in Nee &
      D'Esposito, 2016; 2017.

      The focus in this study will be comparison of FPl-TMS, MFG-TMS, and S1-TMS in an interleaved
      fMRI-TMS-fMRI design. The logic is to test the apical status of the FPl/MFG through the
      extent to which TMS impacts other PFC areas and behavior.

      Each experiment will begin with 1 session of the CCT with fMRI to localize PFC targets. Each
      participant will then perform 3 counter-balanced sessions wherein a different site will be
      targeted by TMS followed immediately by fMRI on the CCT.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Basic Science
masking: Single (Participant)
measure: PFC-PPC effective connectivity
time frame: baseline, pre-intervention and immediately after intervention
description: effective connectivity among areas of the prefrontal and posterior parietal cortex in the blood oxygenation level dependent (BOLD) signal assessed with functional magnetic resonance imaging (fMRI) [note, this measure has no units]
measure: PFC-PPC activation
time frame: baseline, pre-intervention and immediately after intervention
description: blood oxygenation level dependent (BOLD) signal in areas of the prefrontal and posterior parietal cortex assessed with functional magnetic resonance imaging (fMRI) [note, this measure has no units]
measure: temporal control performance
time frame: baseline, pre-intervention and immediately after intervention
description: behavioral performance (reaction time in milliseconds, and percent correct) on conditions involving temporal control in the comprehensive control task
measure: contextual control performance
time frame: baseline, pre-intervention and immediately after intervention
description: behavioral performance (reaction time in milliseconds, and percent correct) on conditions involving contextual control in the comprehensive control task
arm group label: FPl-TMS
arm group type: Experimental
description: Transcranial magnetic stimulation to the lateral frontal pole. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold.
arm group label: MFG-TMS
arm group type: Experimental
description: Transcranial magnetic stimulation to the middle frontal gyrus. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..
arm group label: S1-TMS
arm group type: Active Comparator
description: Transcranial magnetic stimulation to primary somatosensory cortex. 600 pulses delivered in 50 Hz bursts every 5 Hz for 40 seconds at 80% of active motor threshold..
intervention type: Device
intervention name: transcranial magnetic stimulation
description: Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
arm group label: FPl-TMS
arm group label: MFG-TMS
arm group label: S1-TMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Derek E Nee, PhD
role: Principal Investigator
affiliation: Florida State University
last name: Gabriella T Vill, BA
phone: 850-645-4066
email: vill@psy.fsu.edu
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Florida State University
investigator full name: Derek Nee
investigator title: Assistant Professor
sharing ipd: Yes
ipd description: Behavioral and imaging data will be shared
ipd info type: Analytic Code
ipd time frame: Within a year following publication of findings
ipd access criteria: Behavioral and imaging data will be accessible from https://nda.nih.gov/edit_collection.html?id=3448 by NDA users.