<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/NCT01685463</url>
  </required_header>
  <id_info>
    <org_study_id>NIH/NIDA P20 DA022658</org_study_id>
    <secondary_id>P20DA022658</secondary_id>
    <nct_id>NCT01685463</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving</brief_title>
  <official_title>Transcranial Magnetic Stimulation Used to Both Measure Cortical Excitability and Explore Methamphetamine Cue Craving</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of South Carolina</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute on Drug Abuse (NIDA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of South Carolina</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Specific Primary Aims include:&#xD;
&#xD;
      Aim # 1. The investigators explore the feasibility of using the TMS to investigate the&#xD;
      cortical excitability and to inhibit meth cue craving in meth dependent population. The&#xD;
      investigators anticipate that meth elevates cortical excitability measured by motor&#xD;
      threshold, causes changes of cortical silent period, and RC. The investigators also&#xD;
      anticipate that paired pulse measures (short-interval intracortical inhibition,&#xD;
      short-interval intracortical facilitation and long-interval intracortical inhibition) will be&#xD;
      different from healthy control, which are more directly linked to glutamatergic cortical&#xD;
      facilitation and GABAergic inhibition, respectively.&#xD;
&#xD;
      Aim # 2. Given the change of the cortical excitability in meth users, the investigators will&#xD;
      use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to&#xD;
      reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue craving&#xD;
      in meth dependent population compared with sham rTMS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2008</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cue Craving Rating</measure>
    <time_frame>Change from Baseline in Craving rating 10 minutes after TMS</time_frame>
    <description>The subject is asked to rate craving with 0 mm being &quot; no craving at all&quot; and 100 mm representing &quot;the most craving I have ever had&quot;.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Baseline of Resting Motor Threshold</measure>
    <time_frame>Baseline to 10 minutes after TMS</time_frame>
    <description>Resting motor threshold (RMT); on a scale of 0-100 with 100 being most power given to enact a motor response</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Cortical Silent Period</measure>
    <time_frame>Baseline and 10 minutes after TMS</time_frame>
    <description>Cortical Silent Period is measured in seconds</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Recruitment Curve (RC) Slope</measure>
    <time_frame>Baseline and 10 minutes after TMS</time_frame>
    <description>Recruitment Curve (RC) Slope, measured at angle of slope</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Methamphetamine 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 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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham Transcranial Magnetic Stimulation</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcranial Magnetic Stimulation</intervention_name>
    <description>Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses. Electrical stimulation instead.</description>
    <arm_group_label>Transcranial Magnetic Stimulation</arm_group_label>
    <other_name>Magstim Rapid</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>
    <other_name>Epix VT Transcutaneous Electrical Nerve Stimulation Device</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be volunteers who are dependent on meth and not currently seeking treatment. They must&#xD;
             not have received substance abuse treatment within the previous 30 days.&#xD;
&#xD;
          2. Be male or female of any race or ethnic group, between the ages of 18 and 50 years.&#xD;
&#xD;
          3. Meet DSM IV criteria for meth dependence as determined by the MINI International&#xD;
             Neuropsychiatric Interview (MINI).&#xD;
&#xD;
          4. Currently be using meth by smoked, oral, or intravenous routes of administration, used&#xD;
             meth for a minimum of 2 years and a minimum of an average of 3 times a week in the 30&#xD;
             days prior to screening.&#xD;
&#xD;
          5. Be in stable mental and physical health.&#xD;
&#xD;
          6. If female, test non-pregnant and use adequate birth control. All female subjects will&#xD;
             have urine pregnancy tests in all three phases of the study.&#xD;
&#xD;
          7. Be capable of providing written informed consent to participate in this study.&#xD;
&#xD;
          8. Be able to comply with protocol requirements and be likely to complete all study&#xD;
             procedures.&#xD;
&#xD;
          9. Live within a 50 mile radius of our research program, have reliable transportation,&#xD;
             and have a stable residence for at least the 30 days prior to starting the study.&#xD;
&#xD;
         10. Be willing to abstain from alcohol, marijuana and CNS acting prescription and OTC&#xD;
             medications for the 2 week screening and hospitalization phases.&#xD;
&#xD;
         11. Have a positive urine for meth within 72 hours of admission to the hospital phase of&#xD;
             the study and have at least one other positive urine for meth during the screening&#xD;
             phase.&#xD;
&#xD;
         12. Be right-handed.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Have current dependence, defined by DSM IV criteria, on any psychoactive substances&#xD;
             other than meth, nicotine, or caffeine.&#xD;
&#xD;
          2. Have a history and/or test positive for significant hepatic, renal, endocrine,&#xD;
             cardiac, or inflammatory diseases, as well as stroke, seizures, migraine, serious head&#xD;
             trauma, or other neurological disorders that might interfere with stability during the&#xD;
             study or the acquisition of accurate fMRI scans.&#xD;
&#xD;
          3. If female, have intentions to become pregnant during the study.&#xD;
&#xD;
          4. Have been required by the courts to obtain treatment for meth or some other substance&#xD;
             dependence.&#xD;
&#xD;
          5. Be seeking treatment for meth or other substance dependence.&#xD;
&#xD;
          6. Have a medical history or condition considered by the investigators to place the&#xD;
             subject at increased risk (implanted ferrous materials or devices) or to decrease the&#xD;
             likelihood of study completion.&#xD;
&#xD;
          7. Be anticipating elective surgery or hospitalization within 8 weeks of signing the&#xD;
             informed consent agreement.&#xD;
&#xD;
          8. Be on medications in the last 30 days that may alter CNS function or alter fMRI&#xD;
             results. Examples of such medications include but are not limited to the following:&#xD;
             psychotropics, CNS active anti-hypertensives, steroids, anticonvulsants,&#xD;
             antihistamines and CNS OTCs.&#xD;
&#xD;
          9. Have a life time history of major Axis I disorders such as: BPAD, Schizophrenia, PTSD,&#xD;
             or Dementia, or have a current history of Major Depression or suicide attempt within&#xD;
             12 months&#xD;
&#xD;
         10. Have a self report of &gt;21 standard alcohol drinks per week in any week in the 30 days&#xD;
             prior to screening or a Carbohydrate Deficient Transferrin &gt;3.0%.&#xD;
&#xD;
         11. Be unwilling to use a patch and cease smoking cigarettes for the eight days in the&#xD;
             hospital.&#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>Barr MS, Farzan F, Wing VC, George TP, Fitzgerald PB, Daskalakis ZJ. Repetitive transcranial magnetic stimulation and drug addiction. Int Rev Psychiatry. 2011 Oct;23(5):454-66. doi: 10.3109/09540261.2011.618827.</citation>
    <PMID>22200135</PMID>
  </reference>
  <reference>
    <citation>Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.</citation>
    <PMID>19914283</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 10, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <results_first_submitted>July 11, 2018</results_first_submitted>
  <results_first_submitted_qc>October 17, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">October 19, 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>methamphetamine, craving, TMS, cortical excitability, prefrontal cortex</keyword>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Transcranial Magnetic Stimulation</title>
          <description>Transcranial magnetic stimulation (TMS) is a noninvasive 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
        </group>
        <group group_id="P2">
          <title>Sham Transcranial Magnetic Stimulation</title>
          <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Transcranial Magnetic Stimulation</title>
          <description>Transcranial magnetic stimulation (TMS) is a noninvasive 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
        </group>
        <group group_id="B2">
          <title>Sham Transcranial Magnetic Stimulation</title>
          <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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="8"/>
            <count group_id="B3" value="18"/>
          </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="8"/>
                    <measurement group_id="B3" value="18"/>
                  </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>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34.7" spread="10.6"/>
                    <measurement group_id="B2" value="32.5" spread="14.4"/>
                    <measurement group_id="B3" value="33.7" spread="11.2"/>
                  </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="6"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="5"/>
                  </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="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="18"/>
                  </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="8"/>
                    <measurement group_id="B3" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Cue Craving Rating</title>
        <description>The subject is asked to rate craving with 0 mm being &quot; no craving at all&quot; and 100 mm representing &quot;the most craving I have ever had&quot;.</description>
        <time_frame>Change from Baseline in Craving rating 10 minutes after TMS</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation</title>
            <description>Transcranial magnetic stimulation (TMS) is a noninvasive 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Magnetic Stimulation</title>
            <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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>Cue Craving Rating</title>
          <description>The subject is asked to rate craving with 0 mm being &quot; no craving at all&quot; and 100 mm representing &quot;the most craving I have ever had&quot;.</description>
          <units>scores 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="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9.36" spread="0.75"/>
                    <measurement group_id="O2" value="7.92" spread="0.85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Baseline of Resting Motor Threshold</title>
        <description>Resting motor threshold (RMT); on a scale of 0-100 with 100 being most power given to enact a motor response</description>
        <time_frame>Baseline to 10 minutes after TMS</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation</title>
            <description>Transcranial magnetic stimulation (TMS) is a noninvasive 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Magnetic Stimulation</title>
            <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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>Change in Baseline of Resting Motor Threshold</title>
          <description>Resting motor threshold (RMT); on a scale of 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 Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.3" spread="16.2"/>
                    <measurement group_id="O2" value="47.2" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Cortical Silent Period</title>
        <description>Cortical Silent Period is measured in seconds</description>
        <time_frame>Baseline and 10 minutes after TMS</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation</title>
            <description>Transcranial magnetic stimulation (TMS) is a noninvasive 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Magnetic Stimulation</title>
            <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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>Change in Cortical Silent Period</title>
          <description>Cortical Silent Period is measured in seconds</description>
          <units>seconds</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.163" spread=".053"/>
                    <measurement group_id="O2" value=".139" spread=".036"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change Recruitment Curve (RC) Slope</title>
        <description>Recruitment Curve (RC) Slope, measured at angle of slope</description>
        <time_frame>Baseline and 10 minutes after TMS</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Transcranial Magnetic Stimulation</title>
            <description>Transcranial magnetic stimulation (TMS) is a noninvasive 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
          </group>
          <group group_id="O2">
            <title>Sham Transcranial Magnetic Stimulation</title>
            <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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>Change Recruitment Curve (RC) Slope</title>
          <description>Recruitment Curve (RC) Slope, measured at angle of slope</description>
          <units>ratio</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="10"/>
                <count group_id="O2" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value=".272" spread=".196"/>
                    <measurement group_id="O2" value=".135" spread=".073"/>
                  </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 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.&#xD;
Transcranial Magnetic Stimulation: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses.&#xD;
Electrical stimulation instead.</description>
        </group>
        <group group_id="E2">
          <title>Sham Transcranial Magnetic Stimulation</title>
          <description>Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.&#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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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="10"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="8"/>
              </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>Dr. Xingbao Li</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/NCT01685463
org study id: NIH/NIDA P20 DA022658
secondary id: P20DA022658
nct id: NCT01685463
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
Specific Primary Aims include:

      Aim # 1. The investigators explore the feasibility of using the TMS to investigate the
      cortical excitability and to inhibit meth cue craving in meth dependent population. The
      investigators anticipate that meth elevates cortical excitability measured by motor
      threshold, causes changes of cortical silent period, and RC. The investigators also
      anticipate that paired pulse measures (short-interval intracortical inhibition,
      short-interval intracortical facilitation and long-interval intracortical inhibition) will be
      different from healthy control, which are more directly linked to glutamatergic cortical
      facilitation and GABAergic inhibition, respectively.

      Aim # 2. Given the change of the cortical excitability in meth users, the investigators will
      use inhibiting TMS (1 Hz) over medial prefrontal cortex to study whether TMS can be used to
      reduce cue craving. The investigators hypothesize that repetitive TMS reduce meth cue craving
      in meth dependent population compared with sham rTMS.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Cue Craving Rating
time frame: Change from Baseline in Craving rating 10 minutes after TMS
description: The subject is asked to rate craving with 0 mm being " no craving at all" and 100 mm representing "the most craving I have ever had".
measure: Change in Baseline of Resting Motor Threshold
time frame: Baseline to 10 minutes after TMS
description: Resting motor threshold (RMT); on a scale of 0-100 with 100 being most power given to enact a motor response
measure: Change in Cortical Silent Period
time frame: Baseline and 10 minutes after TMS
description: Cortical Silent Period is measured in seconds
measure: Change Recruitment Curve (RC) Slope
time frame: Baseline and 10 minutes after TMS
description: Recruitment Curve (RC) Slope, measured at angle of slope
arm group label: Transcranial Magnetic Stimulation
arm group type: Experimental
description: Transcranial magnetic stimulation (TMS) is a noninvasive 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.
arm group label: Sham Transcranial Magnetic Stimulation
arm group type: Placebo Comparator
description: Sham-TMS procedures: After rTMS determination, participants were fitted with two electrodes on the scalp just below the hairline. Electrodes will be connected to an Epix VT Transcutaneous Electrical nerve stimulation device.
intervention type: Device
intervention name: Transcranial Magnetic Stimulation
description: Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses. Electrical stimulation instead.
arm group label: Transcranial Magnetic Stimulation
other name: Magstim Rapid
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
other name: Epix VT 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: Barr MS, Farzan F, Wing VC, George TP, Fitzgerald PB, Daskalakis ZJ. Repetitive transcranial magnetic stimulation and drug addiction. Int Rev Psychiatry. 2011 Oct;23(5):454-66. doi: 10.3109/09540261.2011.618827.
PMID: 22200135
citation: Feil J, Zangen A. Brain stimulation in the study and treatment of addiction. Neurosci Biobehav Rev. 2010 Mar;34(4):559-74. doi: 10.1016/j.neubiorev.2009.11.006. Epub 2009 Nov 13.
PMID: 19914283
responsible party type: Sponsor
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 