<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/NCT03259568</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00082433</org_study_id>
    <nct_id>NCT03259568</nct_id>
  </id_info>
  <brief_title>Effects of rTMS on Human Brain Activity Measured With fMRI</brief_title>
  <official_title>Effects of rTMS on Human Brain Activity Measured With fMRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke 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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS)&#xD;
      on neural circuits as a function of spatiotemporal parameters and brain state in order to&#xD;
      better understand why the method works and how to improve its efficacy. Leveraging our&#xD;
      expertise in application of TMS methodology during concurrent single neuron recording&#xD;
      techniques in non-human primates and imaging and scalp potential techniques in humans, the&#xD;
      investigators aim to resolve three interlocking problems in the design and application of&#xD;
      rTMS: stimulation frequency, spatial targeting, and interactions with brain state.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Slow enrollment due to Covid-19.&#xD;
  </why_stopped>
  <start_date type="Actual">January 12, 2018</start_date>
  <completion_date type="Actual">August 20, 2019</completion_date>
  <primary_completion_date type="Actual">August 20, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study (&quot;arms&quot;) are repeated within each participant (20%, 40%, 80%, or 120% of an individual's titrated resting motor threshold).</intervention_model_description>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Participant is not informed about TMS intensity.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Motion Perception Accuracy</measure>
    <time_frame>during each TMS session, up to 3 hours</time_frame>
    <description>Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Reaction Time</measure>
    <time_frame>during each TMS session, up to 3 hours</time_frame>
    <description>Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Activation of Cortical Networks During a Visual Motion Task.</measure>
    <time_frame>during each TMS session, up to 3 hours</time_frame>
    <description>Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Human Brain Activity</condition>
  <arm_group>
    <arm_group_label>Dose-response TMS - Intensity = 20%RMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose-response TMS - Intensity = 40%RMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose-response TMS - Intensity = 80%RMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose-response TMS - Intensity = 120%RMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive TMS</intervention_name>
    <description>1-10 Hertz rTMS will be administered</description>
    <arm_group_label>Dose-response TMS - Intensity = 120%RMT</arm_group_label>
    <arm_group_label>Dose-response TMS - Intensity = 20%RMT</arm_group_label>
    <arm_group_label>Dose-response TMS - Intensity = 40%RMT</arm_group_label>
    <arm_group_label>Dose-response TMS - Intensity = 80%RMT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18-30.&#xD;
&#xD;
          2. Use of effective method of birth control for women of childbearing capacity.&#xD;
&#xD;
          3. Willing to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current or recent (within the past 6 months) of substance abuse or dependence,&#xD;
             excluding nicotine and caffeine (urine test).&#xD;
&#xD;
          2. Current serious medical illness (self report).&#xD;
&#xD;
          3. History of seizure except those therapeutically induced by ECT (childhood febrile&#xD;
             seizures are acceptable and these subjects may be included in the study), history of&#xD;
             epilepsy in self or first degree relatives, stroke, brain surgery, head injury,&#xD;
             cranial metal implants, known structural brain lesion, devices that may be affected by&#xD;
             rTMS or MRI (pacemaker, medication pump, cochlear implant, implanted brain&#xD;
             stimulator); [TMS Adult Safety Screening (TASS) form].&#xD;
&#xD;
          4. Subjects are unable or unwilling to give informed consent.&#xD;
&#xD;
          5. Diagnosed any Axis I DSM-IV disorder (MINI, DSM-IV)&#xD;
&#xD;
          6. Subjects with a clinically defined neurological disorder including, but not limited&#xD;
             to:&#xD;
&#xD;
               1. Any condition likely to be associated with increased intracranial pressure&#xD;
&#xD;
               2. Space occupying brain lesion.&#xD;
&#xD;
               3. History of stroke.&#xD;
&#xD;
               4. Transient ischemic attack within two years.&#xD;
&#xD;
               5. Cerebral aneurysm.&#xD;
&#xD;
               6. Dementia.&#xD;
&#xD;
               7. Mini Mental Status Exam (MMSE) score of &lt;24.&#xD;
&#xD;
               8. Parkinson's disease.&#xD;
&#xD;
               9. Huntington's disease.&#xD;
&#xD;
             i. Multiple sclerosis.&#xD;
&#xD;
          7. Increased risk of seizure for any reason, including prior diagnosis of increased&#xD;
             intracranial pressure (such as after large infarctions or trauma), or currently taking&#xD;
             medication that lowers the seizure threshold.&#xD;
&#xD;
          8. Subjects with cochlear implants&#xD;
&#xD;
          9. Subjects not willing to tolerate the confinement associated with being in the MRI&#xD;
             scanner.&#xD;
&#xD;
         10. Women who are pregnant or breast-feeding (urine test).&#xD;
&#xD;
         11. Blindness.&#xD;
&#xD;
         12. Inability to read or understand English.&#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>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <results_first_submitted>January 10, 2023</results_first_submitted>
  <results_first_submitted_qc>March 3, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 29, 2023</results_first_posted>
  <disposition_first_submitted>January 24, 2022</disposition_first_submitted>
  <disposition_first_submitted_qc>March 3, 2023</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">March 29, 2023</disposition_first_posted>
  <last_update_submitted>March 3, 2023</last_update_submitted>
  <last_update_submitted_qc>March 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>TMS</keyword>
  <keyword>BOLD activity</keyword>
  <keyword>Network activity</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>April 23, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03259568/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 16, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03259568/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Active rTMS</title>
          <description>Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant performance was low</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Study used a within-subjects design; all 27 participants received all 4 conditions (&quot;arms&quot;) of TMS stimulation.</population>
      <group_list>
        <group group_id="B1">
          <title>Active rTMS (Repetitive Transcranial Magnetic Stimulation)</title>
          <description>Repetitive TMS: 1-10 Hertz rTMS will be administered, at varying levels of TMS intensity.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="27"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23.7" spread="2.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <population>Within-subjects design, each subject received four TMS conditions (&quot;arms&quot;).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <population>Within-subjects design, all conditions (&quot;arms&quot;) were repeated in each of the 27 participants.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>fMRI Activity</title>
          <description>Measure reflects TMS-evoked activity associated with each TMS Intensity condition (&quot;arm&quot;), i.e., 20%, 40%, 80%, and 120% of an individualized resting motor threshold.</description>
          <units>BOLD response</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>20% RMT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.28" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>40% RMT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.28" spread="0.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>80% RMT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.20" spread="0.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>120% RMT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1.25" spread="0.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Motion Perception Accuracy</title>
        <description>Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)</description>
        <time_frame>during each TMS session, up to 3 hours</time_frame>
        <population>Within-subjects manipulation (same subjects for each condition).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose-response TMS - Intensity = 20%RMT</title>
            <description>Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O2">
            <title>Dose-response TMS - Intensity = 40%RMT</title>
            <description>Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O3">
            <title>Dose-response TMS - Intensity = 80%RMT</title>
            <description>Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O4">
            <title>Dose-response TMS - Intensity = 120%RMT</title>
            <description>Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
        </group_list>
        <measure>
          <title>Motion Perception Accuracy</title>
          <description>Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)</description>
          <population>Within-subjects manipulation (same subjects for each condition).</population>
          <units>Percentage of correct responses</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="63" spread="4.0"/>
                    <measurement group_id="O2" value="62" spread="4.0"/>
                    <measurement group_id="O3" value="58" spread="4.0"/>
                    <measurement group_id="O4" value="61" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Reaction Time</title>
        <description>Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)</description>
        <time_frame>during each TMS session, up to 3 hours</time_frame>
        <population>Within-subjects manipulation (same subjects for each condition).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose-response TMS - Intensity = 20%RMT</title>
            <description>Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O2">
            <title>Dose-response TMS - Intensity = 40%RMT</title>
            <description>Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O3">
            <title>Dose-response TMS - Intensity = 80%RMT</title>
            <description>Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O4">
            <title>Dose-response TMS - Intensity = 120%RMT</title>
            <description>Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
        </group_list>
        <measure>
          <title>Reaction Time</title>
          <description>Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)</description>
          <population>Within-subjects manipulation (same subjects for each condition).</population>
          <units>milliseconds</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="814" spread="104"/>
                    <measurement group_id="O2" value="784" spread="94"/>
                    <measurement group_id="O3" value="762" spread="85"/>
                    <measurement group_id="O4" value="810" spread="109"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Activation of Cortical Networks During a Visual Motion Task.</title>
        <description>Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal</description>
        <time_frame>during each TMS session, up to 3 hours</time_frame>
        <population>Within-subjects manipulation (same subjects for each condition).</population>
        <group_list>
          <group group_id="O1">
            <title>Dose-response TMS - Intensity = 20%RMT</title>
            <description>Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O2">
            <title>Dose-response TMS - Intensity = 40%RMT</title>
            <description>Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O3">
            <title>Dose-response TMS - Intensity = 80%RMT</title>
            <description>Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
          <group group_id="O4">
            <title>Dose-response TMS - Intensity = 120%RMT</title>
            <description>Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
          </group>
        </group_list>
        <measure>
          <title>Activation of Cortical Networks During a Visual Motion Task.</title>
          <description>Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal</description>
          <population>Within-subjects manipulation (same subjects for each condition).</population>
          <units>BOLD activity</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="24"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="24"/>
                <count group_id="O4" value="24"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.89" spread="0.06"/>
                    <measurement group_id="O2" value="0.87" spread="0.05"/>
                    <measurement group_id="O3" value="0.88" spread="0.06"/>
                    <measurement group_id="O4" value="0.94" spread="0.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 3 months</time_frame>
      <desc>Study used a within-subjects design; all 27 participants received all 4 conditions (&quot;arms&quot;) of TMS stimulation.</desc>
      <group_list>
        <group group_id="E1">
          <title>Dose-response TMS - Intensity = 20%RMT</title>
          <description>Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
        </group>
        <group group_id="E2">
          <title>Dose-response TMS - Intensity = 40%RMT</title>
          <description>Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
        </group>
        <group group_id="E3">
          <title>Dose-response TMS - Intensity = 80%RMT</title>
          <description>Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
        </group>
        <group group_id="E4">
          <title>Dose-response TMS - Intensity = 120%RMT</title>
          <description>Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.&#xD;
Outcome measures include accuracy, RT, and BOLD signal.&#xD;
Repetitive TMS: 1-10 Hertz rTMS will be administered</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="27"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Simon W Davis</name_or_title>
      <organization>Dept of Neurology, Duke University School of Medicine</organization>
      <phone>9195991927</phone>
      <email>simon.davis@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03259568
org study id: Pro00082433
nct id: NCT03259568
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This project investigates the effects of repetitive transcranial magnetic stimulation (rTMS)
      on neural circuits as a function of spatiotemporal parameters and brain state in order to
      better understand why the method works and how to improve its efficacy. Leveraging our
      expertise in application of TMS methodology during concurrent single neuron recording
      techniques in non-human primates and imaging and scalp potential techniques in humans, the
      investigators aim to resolve three interlocking problems in the design and application of
      rTMS: stimulation frequency, spatial targeting, and interactions with brain state.
allocation: Non-Randomized
intervention model: Factorial Assignment
intervention model description: The study is a within-subjects design focused on estimating the fMRI BOLD response to different levels of TMS intensity. The conditions in the study ("arms") are repeated within each participant (20%, 40%, 80%, or 120% of an individual's titrated resting motor threshold).
primary purpose: Basic Science
masking: Single (Participant)
masking description: Participant is not informed about TMS intensity.
measure: Motion Perception Accuracy
time frame: during each TMS session, up to 3 hours
description: Acute effect of a rTMS session on the performance for a motion task, as measured by accuracy (in percentage of correct responses)
measure: Reaction Time
time frame: during each TMS session, up to 3 hours
description: Acute effect of a rTMS session on the performance for a motion task, as measured by reaction time (in ms)
measure: Activation of Cortical Networks During a Visual Motion Task.
time frame: during each TMS session, up to 3 hours
description: Acute effect of a rTMS session on fMRI activation during a motion task, as measured by the change in BOLD signal
arm group label: Dose-response TMS - Intensity = 20%RMT
arm group type: Experimental
description: Four levels of TMS intensity (here, 20% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
arm group label: Dose-response TMS - Intensity = 40%RMT
arm group type: Experimental
description: Four levels of TMS intensity (here, 40% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
arm group label: Dose-response TMS - Intensity = 80%RMT
arm group type: Experimental
description: Four levels of TMS intensity (here, 80% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
arm group label: Dose-response TMS - Intensity = 120%RMT
arm group type: Experimental
description: Four levels of TMS intensity (here, 120% of Resting Motor Threshold), titrated to each individual, tested within the MRI.
Outcome measures include accuracy, RT, and BOLD signal.
intervention type: Device
intervention name: Repetitive TMS
description: 1-10 Hertz rTMS will be administered
arm group label: Dose-response TMS - Intensity = 120%RMT
arm group label: Dose-response TMS - Intensity = 20%RMT
arm group label: Dose-response TMS - Intensity = 40%RMT
arm group label: Dose-response TMS - Intensity = 80%RMT
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 