<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/NCT01690130</url>
  </required_header>
  <id_info>
    <org_study_id>Brain Stimulation Lab / MUSC</org_study_id>
    <nct_id>NCT01690130</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation Effects on Nicotine Craving</brief_title>
  <official_title>Transcranial Magnetic Stimulation Effects on Nicotine Craving</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The proposed study will measure the change of cortical excitability during nicotine craving&#xD;
      and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine&#xD;
      craving and cue-reactivity among adult regular smokers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot protocol proposes to test and further develop TMS for the purpose of studying&#xD;
      brain function in nicotine users.&#xD;
&#xD;
      Specific Primary Aims include:&#xD;
&#xD;
      Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers&#xD;
      and explore the potential use of TMS in cigarette smokers.&#xD;
&#xD;
      Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will&#xD;
      examine whether modulating prefrontal activity through rTMS will impact measures of craving&#xD;
      and the reinforcing effects of nicotine.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      The study was a randomized, blind, sham-controlled crossover study in which participants will&#xD;
      involve two study visits. Participants will have an initial assessment about tobacco use&#xD;
      habits and craving patterns. Participant will look at images related to and not related to&#xD;
      cigarette smoking.&#xD;
&#xD;
      Participants will receive two different types of brain stimulation with repetitive TMS (10&#xD;
      Hz): sham rTMS and active rTMS over prefrontal cortex. Craving assessments will be performed&#xD;
      before and after each stimulus experiment.&#xD;
&#xD;
      Participants will be measured cortical excitability with TMS before and after each stimulus&#xD;
      experiment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2009</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the Change From Baseline in Cue Nicotine Craving Rating Score</measure>
    <time_frame>Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)</time_frame>
    <description>Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the Change From Baseline in Resting Motor Threshold</measure>
    <time_frame>20 minutes before (baseline) and 20 minutes after rTMS experiment</time_frame>
    <description>Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Nicotine Dependence</condition>
  <arm_group>
    <arm_group_label>Transcranial Magnetic Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Transcranial Magnetic Stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation (Neuronetics)</intervention_name>
    <description>Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.</description>
    <arm_group_label>Sham Transcranial Magnetic Stimulation</arm_group_label>
    <arm_group_label>Transcranial Magnetic Stimulation</arm_group_label>
    <other_name>Neuronetics® Model 3600</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham Transcranial Magnetic Stimulation</intervention_name>
    <description>The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.</description>
    <arm_group_label>Sham Transcranial Magnetic Stimulation</arm_group_label>
    <arm_group_label>Transcranial Magnetic Stimulation</arm_group_label>
    <other_name>Transcutaneous Electrical Nerve Stimulation Device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Right handed males and females, between the ages of 18 and 50&#xD;
&#xD;
          -  Daily smokers who smoke at least 10 cigarettes per day for at least past 1 year&#xD;
&#xD;
          -  Mentally capable of reading, writing, giving consent, following instructions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of seizures&#xD;
&#xD;
          -  taking medications that lower seizure threshold&#xD;
&#xD;
          -  implanted metal devices (e.g., pacemakers, metal plates, wires)&#xD;
&#xD;
          -  pregnant&#xD;
&#xD;
          -  history of brain surgery or history of loss of consciousness &gt;15 minutes&#xD;
&#xD;
          -  any unstable major axis I psychiatric disorder in the past month (e.g. psychotic&#xD;
             disorders)&#xD;
&#xD;
          -  Current substance use disorders other than nicotine and caffeine use, in the past 30&#xD;
             days&#xD;
&#xD;
          -  Any medication (e.g., propranolol) or unstable medical condition that may interfere&#xD;
             with psychophysiological (e.g., heart rate) monitoring&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Amiaz R, Levy D, Vainiger D, Grunhaus L, Zangen A. Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addiction. 2009 Apr;104(4):653-60. doi: 10.1111/j.1360-0443.2008.02448.x. Epub 2009 Jan 12.</citation>
    <PMID>19183128</PMID>
  </reference>
  <reference>
    <citation>Eichhammer P, Johann M, Kharraz A, Binder H, Pittrow D, Wodarz N, Hajak G. High-frequency repetitive transcranial magnetic stimulation decreases cigarette smoking. J Clin Psychiatry. 2003 Aug;64(8):951-3. doi: 10.4088/jcp.v64n0815.</citation>
    <PMID>12927012</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <results_first_submitted>July 19, 2018</results_first_submitted>
  <results_first_submitted_qc>October 24, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">November 21, 2018</results_first_posted>
  <last_update_submitted>March 30, 2020</last_update_submitted>
  <last_update_submitted_qc>March 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>nicotine</keyword>
  <keyword>craving</keyword>
  <keyword>smoking</keyword>
  <keyword>TMS</keyword>
  <keyword>prefrontal cortex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transcranial Magnetic Stimulation, Then Sham</title>
          <description>Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.</description>
        </group>
        <group group_id="P2">
          <title>Sham Transcranial Magnetic Stimulation, Then TMS</title>
          <description>Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.&#xD;
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Subject have cancelled visit.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transcranial Magnetic Stimulation, Then Sham</title>
          <description>Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.</description>
        </group>
        <group group_id="B2">
          <title>Sham Transcranial Magnetic Stimulation, Then TMS</title>
          <description>Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.&#xD;
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
            <count group_id="B2" value="9"/>
            <count group_id="B3" value="19"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="42" spread="11.5"/>
                    <measurement group_id="B2" value="42" spread="11.5"/>
                    <measurement group_id="B3" value="42" spread="11.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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 group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <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="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>the Change From Baseline in Cue Nicotine Craving Rating Score</title>
        <description>Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.</description>
        <time_frame>Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation</title>
            <description>Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Magnetic Stimulation</title>
            <description>Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.&#xD;
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in Cue Nicotine Craving Rating Score</title>
          <description>Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="64" spread="5.9"/>
                    <measurement group_id="O2" value="46" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>the Change From Baseline in Resting Motor Threshold</title>
        <description>Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response</description>
        <time_frame>20 minutes before (baseline) and 20 minutes after rTMS experiment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation</title>
            <description>Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Magnetic Stimulation</title>
            <description>Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.&#xD;
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.</description>
          </group>
        </group_list>
        <measure>
          <title>the Change From Baseline in Resting Motor Threshold</title>
          <description>Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42" spread="8.1"/>
                    <measurement group_id="O2" value="44" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Transcranial Magnetic Stimulation</title>
          <description>Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.</description>
        </group>
        <group group_id="E2">
          <title>Sham Transcranial Magnetic Stimulation</title>
          <description>Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)&#xD;
Transcranial Magnetic Stimulation (Neuronetics): Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.&#xD;
Sham Transcranial Magnetic Stimulation: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.</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="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>mild discomfort</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="19"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>TMS in Nicotine Craving</name_or_title>
      <organization>Medical University of South Carolina</organization>
      <phone>8437925729</phone>
      <email>lixi@musc.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/NCT01690130
org study id: Brain Stimulation Lab / MUSC
nct id: NCT01690130
lead sponsor: 
has dmc: No
The proposed study will measure the change of cortical excitability during nicotine craving
      and examine the effects of Repetitive Transcranial Magnetic Stimulation (rTMS) on nicotine
      craving and cue-reactivity among adult regular smokers.
This pilot protocol proposes to test and further develop TMS for the purpose of studying
      brain function in nicotine users.

      Specific Primary Aims include:

      Aim # 1. To test change of cortical excitability during nicotine craving in cigarette smokers
      and explore the potential use of TMS in cigarette smokers.

      Aim # 2. Given the role of the prefrontal cortex (and connected regions) in craving, we will
      examine whether modulating prefrontal activity through rTMS will impact measures of craving
      and the reinforcing effects of nicotine.

      Design:

      The study was a randomized, blind, sham-controlled crossover study in which participants will
      involve two study visits. Participants will have an initial assessment about tobacco use
      habits and craving patterns. Participant will look at images related to and not related to
      cigarette smoking.

      Participants will receive two different types of brain stimulation with repetitive TMS (10
      Hz): sham rTMS and active rTMS over prefrontal cortex. Craving assessments will be performed
      before and after each stimulus experiment.

      Participants will be measured cortical excitability with TMS before and after each stimulus
      experiment.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: the Change From Baseline in Cue Nicotine Craving Rating Score
time frame: Before rMTS (baseline) and after rTMS experiment (on average 15 minutes)
description: Seventy highly palatable scenic images, forty neutral control images) and forty cigarette smoking cue images were presented in four blocks. Immediately after viewing each block of cue images, participants completed a 10 question computerized visual analog scale (CVAS) designed to assess craving. Each question is followed by a CVAS (range 0 - 100) 0 means least amount of craving and 100 means the maximum amount of craving. After 15 minutes of real or sham rTMS, participants viewed the images again and rated their cravings. At each visit, participants were blind to the rTMS condition (real or sham) and the order was randomized.
measure: the Change From Baseline in Resting Motor Threshold
time frame: 20 minutes before (baseline) and 20 minutes after rTMS experiment
description: Resting Motor Threshold (RMT) on a scale from 0-100, with 100 being most power given to enact a motor response
arm group label: Transcranial Magnetic Stimulation
arm group type: Experimental
description: Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual.The brain stimulation techniques could theoretically improve the efficacy of smoking cessation. Treatment was standardized at 100% magnetic field intensity relative to the participant's resting MT, at 10 pulses per second (10 Hz) for 5 seconds, with an intertrain interval of 10 seconds. Treatment session lasted for 15 minutes with 3000 pulses.
arm group label: Sham Transcranial Magnetic Stimulation
arm group type: Sham Comparator
description: Sham-TMS procedures: After rMT determination and DLPFC cortex localization, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes were connected to an Epix VT® Transcutaneous Electrical Nerve Stimulation Device (Empi; St. Paul, MN, USA)
intervention type: Device
intervention name: Transcranial Magnetic Stimulation (Neuronetics)
description: Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.
arm group label: Sham Transcranial Magnetic Stimulation
arm group label: Transcranial Magnetic Stimulation
other name: Neuronetics® Model 3600
intervention type: Device
intervention name: Sham Transcranial Magnetic Stimulation
description: The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.
arm group label: Sham Transcranial Magnetic Stimulation
arm group label: Transcranial Magnetic Stimulation
other name: Transcutaneous Electrical Nerve Stimulation Device
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
citation: Amiaz R, Levy D, Vainiger D, Grunhaus L, Zangen A. Repeated high-frequency transcranial magnetic stimulation over the dorsolateral prefrontal cortex reduces cigarette craving and consumption. Addiction. 2009 Apr;104(4):653-60. doi: 10.1111/j.1360-0443.2008.02448.x. Epub 2009 Jan 12.
PMID: 19183128
citation: Eichhammer P, Johann M, Kharraz A, Binder H, Pittrow D, Wodarz N, Hajak G. High-frequency repetitive transcranial magnetic stimulation decreases cigarette smoking. J Clin Psychiatry. 2003 Aug;64(8):951-3. doi: 10.4088/jcp.v64n0815.
PMID: 12927012
responsible party type: Sponsor
mesh term: Tobacco Use Disorder
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 