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/NCT05962385</url>
    </required_header>
    <id_info>
      <org_study_id>PSYCH-2023-32060</org_study_id>
      <nct_id>NCT05962385</nct_id>
    </id_info>
    <brief_title>State Dependence of Prefrontal Transcranial Magnetic Stimulation</brief_title>
    <official_title>State Dependence of Prefrontal Transcranial Magnetic Stimulation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Minnesota</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will examine whether the benefits of brain stimulation on mental functioning can be&#xD;
        enhanced if an individual is actively engaging the target brain networks while receiving&#xD;
        brain stimulation. The study includes two separate sessions and people will complete either a&#xD;
        cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The&#xD;
        study will measure change in brain function with EEG.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 24, 2023</start_date>
    <completion_date type="Anticipated">July 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 24, 2024</primary_completion_date>
    <phase>Phase 4</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>
      <intervention_model_description>Repeated measures design - across two separate sessions (one week apart, counterbalanced between participants), participants will receive transcranial magnetic stimulation (TMS) whilst engaging in either a cognitive control or a perceptual task.</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>No blinding is possible</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Theta-gamma cross frequency coupling</measure>
      <time_frame>0-500 ms after each TMS stimulus</time_frame>
      <description>A metric of brain function measured with EEG - the coupling of theta oscillation phase with gamma power. This will be measured immediately following the intervention (TMS stimulation).</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Cortical excitability</measure>
      <time_frame>60-300 ms after each TMS stimulus</time_frame>
      <description>TMS-evoked potentials will be measured with EEG to examine cortical excitability after TMS. This will be measured immediately following the intervention (TMS stimulation).</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Healthy</condition>
    <arm_group>
      <arm_group_label>Healthy control</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>All participants receive the same procedures</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Brain state while receiving TMS</intervention_name>
      <description>Brain state whilst receiving TMS - cognitive control or perceptual. Repeated measures design, so all participants receive the same procedures.</description>
      <arm_group_label>Healthy control</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age 18 - 65,&#xD;
  &#xD;
            -  healthy controls&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Diagnosed psychiatric disorder&#xD;
  &#xD;
            -  Potential contraindications to EEG (e.g. visible scalp abrasions, non-removable hair&#xD;
               extensions and/or hair styling that would impede proper EEG recording)&#xD;
  &#xD;
            -  Potential contraindication to TMS (as identified by the TMS safety screener)&#xD;
  &#xD;
            -  Any previous adverse reaction to TMS or MRI&#xD;
  &#xD;
            -  Diagnosed epilepsy or previously experienced a seizure&#xD;
  &#xD;
            -  Diagnosed neurological condition, such as stroke or tinnitus&#xD;
  &#xD;
            -  Experienced a head trauma that was diagnosed as concussion&#xD;
  &#xD;
            -  Current use of, or recent withdrawal from, medications that can increase the risk of&#xD;
               seizure&#xD;
  &#xD;
            -  Currently pregnant&#xD;
  &#xD;
            -  Any metal in the head (excluding mouth)&#xD;
  &#xD;
            -  Any implanted medical device&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Alik Widge</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Minnesota</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Aaron Mclnnes, PhD</last_name>
      <phone>612-300-7801</phone>
      <email>mcinn125@umn.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University of Minnesota</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Aaron Mclnnes, PhD</last_name>
        <phone>612-300-7801</phone>
        <email>mcinn125@umn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT05962385
  org study id: PSYCH-2023-32060
  nct id: NCT05962385
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  The study will examine whether the benefits of brain stimulation on mental functioning can be
        enhanced if an individual is actively engaging the target brain networks while receiving
        brain stimulation. The study includes two separate sessions and people will complete either a
        cognitive task or a perceptual task while receiving transcranial magnetic stimulation. The
        study will measure change in brain function with EEG.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Repeated measures design - across two separate sessions (one week apart, counterbalanced between participants), participants will receive transcranial magnetic stimulation (TMS) whilst engaging in either a cognitive control or a perceptual task.
  primary purpose: Basic Science
  masking: None (Open Label)
  masking description: No blinding is possible
  measure: Theta-gamma cross frequency coupling
  time frame: 0-500 ms after each TMS stimulus
  description: A metric of brain function measured with EEG - the coupling of theta oscillation phase with gamma power. This will be measured immediately following the intervention (TMS stimulation).
  measure: Cortical excitability
  time frame: 60-300 ms after each TMS stimulus
  description: TMS-evoked potentials will be measured with EEG to examine cortical excitability after TMS. This will be measured immediately following the intervention (TMS stimulation).
  arm group label: Healthy control
  arm group type: Experimental
  description: All participants receive the same procedures
  intervention type: Device
  intervention name: Brain state while receiving TMS
  description: Brain state whilst receiving TMS - cognitive control or perceptual. Repeated measures design, so all participants receive the same procedures.
  arm group label: Healthy control
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Alik Widge
  role: Principal Investigator
  affiliation: University of Minnesota
  last name: Aaron Mclnnes, PhD
  phone: 612-300-7801
  email: mcinn125@umn.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor