<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/NCT03827265</url>
  </required_header>
  <id_info>
    <org_study_id>18-000509</org_study_id>
    <secondary_id>1K99DA045749-01</secondary_id>
    <nct_id>NCT03827265</nct_id>
  </id_info>
  <brief_title>Transcranial Magnetic Stimulation and Tobacco Use Disorder</brief_title>
  <official_title>Transcranial Magnetic Stimulation and Tobacco Use Disorder: A Network-Level Approach With Attention to Sex as a Biological Variable</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</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>
    <collaborator>
      <agency>Food and Drug Administration (FDA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if brain stimulation using repetitive transcranial&#xD;
      magnetic stimulation (rTMS) directed at different parts of the brain can decrease feelings of&#xD;
      cigarette craving and symptoms of cigarette withdrawal, and also if men and women have&#xD;
      different responses to rTMS.&#xD;
&#xD;
      Participants will visit the University of California, Los Angeles (UCLA) five times: First,&#xD;
      for in-person screening, then for four rTMS sessions, four three different brain regions.&#xD;
      Everyone in the study will be assigned to all four treatment arms and they will take place in&#xD;
      a random order. Before and after each rTMS session, a brief MRI will be performed, and&#xD;
      participants will be asked to fill out questionnaires that describe how they are feeling.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      After the initial telephone screening, potentially eligible candidates will meet with staff&#xD;
      and receive a lay-language explanation of the study. Candidates will review, ask about, and&#xD;
      sign the informed consent form for the study. Those who have difficulty understanding the&#xD;
      information will be able to review and ask questions to a staff member, who will help clarify&#xD;
      the requirements, potential risks and benefits of participation. Any participant who is&#xD;
      unable to demonstrate understanding of the information presented despite assistance will be&#xD;
      excluded. Participants may withdraw from the study at any time. They may also be withdrawn at&#xD;
      the discretion of the investigators for inability to comply with procedures or if continuing&#xD;
      participation is unsafe or not in their best interest. Any participant expressing a desire&#xD;
      for smoking cessation treatment, at any point during screening or while engaged in the study,&#xD;
      will be referred to appropriate counseling services.&#xD;
&#xD;
      Once the informed consent is obtained, participants will undergo a psychological evaluation&#xD;
      (MINI) by trained study staff to rule out any exclusionary psychiatric diagnoses.&#xD;
      Participants will provide a urine sample to be used for pregnancy and toxicology tests.&#xD;
&#xD;
      They will complete a series of questionnaires to provide demographic information, and&#xD;
      complete the Fagerström Test for Nicotine Dependence, Smoking History Questionnaire, Timeline&#xD;
      Follow Back (TLFB) to report smoking over the month before testing, Substance Use Inventory,&#xD;
      as well as the Beck Depression Inventory, Beck Anxiety Inventory, and Positive and Negative&#xD;
      Affect Scale (PANAS) to measure mood state and traits before beginning the study. Daily&#xD;
      smoker status will be tested at screening.&#xD;
&#xD;
      Test Day Procedures:&#xD;
&#xD;
        1. Evaluation of wakefulness. Due to the possibility that sleep deprivation may reduce the&#xD;
           seizure threshold, wakefulness will be self-reported via the Stanford Sleepiness Scale.&#xD;
           Participants who score below a 5 will be asked to reschedule their appointment and&#xD;
           return when they are better rested.&#xD;
&#xD;
        2. Abstinence from Drug and Alcohol Use. Each study will begin with a urine test to verify&#xD;
           abstinence from drugs of abuse and a Breathalyzer test to verify abstinence from&#xD;
           alcohol.&#xD;
&#xD;
        3. Smoking Abstinence. Expired air will be sampled for CO to verify overnight abstinence.&#xD;
           Participants who are not abstinent will be allowed to return for testing on another day.&#xD;
&#xD;
        4. Pregnancy Testing. Female participants will each have a urine test to confirm absence of&#xD;
           pregnancy.&#xD;
&#xD;
        5. Self-report of Spontaneous Craving. Data will be obtained on the 10-item Urge to Smoke&#xD;
           Scale. Self-reports for each item are given on a scale from 1-7, with 1 = definitely not&#xD;
           and 7 = definitely.&#xD;
&#xD;
        6. Self-report of Withdrawal. Participants will complete the Shiffman-Jarvik Withdrawal&#xD;
           Scale, a 25-item questionnaire comprised of five scales: Craving; Psychological&#xD;
           Withdrawal; Physiological Withdrawal; Stimulation/Sedation; and Appetite. Each question&#xD;
           is rated on a 7-point scale (1 = definitely not to 7 = definitely) to indicate the&#xD;
           respondent's feeling state. Scores are calculated as the mean response to each question&#xD;
           on each particular subscale.&#xD;
&#xD;
        7. Self-report of Mood. Participants will complete the Positive and Negative Affect&#xD;
           Schedule (PANAS), a 20-item questionnaire comprising two mood scales (positive and&#xD;
           negative). Each item is rated on a 5-point scale ranging from 1 (very slightly or not at&#xD;
           all) to 5 (extremely) to indicate their feeling state.&#xD;
&#xD;
        8. fMRI. Resting-state fMRI data will be collected while participants lie in the scanner&#xD;
           with eyes open viewing a black screen. The scan duration is 8 minutes. Identical&#xD;
           scanning procedures will be performed once before rTMS, and once after.&#xD;
&#xD;
        9. rTMS. Subjects will first undergo Motor Threshold (MT) determination using single pulses&#xD;
           applied to the left motor cortex, with motor response determined using electromyography&#xD;
           (EMG) electrodes applied to the right hand (standard clinical procedures). On active&#xD;
           test days, rTMS will be performed using 10 Hz stimulation, a treatment paradigm that has&#xD;
           previously reduced craving, with 3000 pulses administered over 15 min at 100% MT with 5&#xD;
           sec pulse trains and 10 sec inter-train interval. Participants will receive this&#xD;
           stimulation to the left posterior parietal cortex, dorsolateral prefrontal cortex, and&#xD;
           superior frontal gyrus on separate test days.&#xD;
&#xD;
       10. Repeated self-reports of craving, withdrawal, and mood (items 4-6).&#xD;
&#xD;
       11. Repeat fMRI.&#xD;
&#xD;
      Study timeline:&#xD;
&#xD;
      Each of the 4 TMS study visits will be scheduled at least 24 h apart to allow for washout.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2019</start_date>
  <completion_date type="Anticipated">February 2024</completion_date>
  <primary_completion_date type="Anticipated">February 2024</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>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>This is a single-blind study and only the participant will not be aware of when they will be undergoing the sham stimulation arm.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Repetitive Transcranial Magnetic Stimulation (rTMS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Data from the brain regions that will be targeted with repetitive transcranial magnetic stimulation (rTMS) will be used to assess changes in craving, withdrawal, and affect</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urge to Smoke Questionnaire</measure>
    <time_frame>4 weeks</time_frame>
    <description>A 10-item self-report questionnaire used to measure spontaneous craving</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Shiffman-Jarvik Withdrawal Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>A 25-item self-report questionnaire used to measure withdrawal</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>A 20-item questionnaire used to measure mood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Baseline Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>4 Weeks</time_frame>
    <description>Resting-state fMRI data will be collected before the TMS session</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-stimulation Magnetic Resonance Imaging (MRI)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Resting-state fMRI data will be collected after the TMS session</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Tobacco Use Disorder</condition>
  <arm_group>
    <arm_group_label>TMS on SFG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: repetitive transcranial magnetic stimulation (real)&#xD;
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the superior frontal gyrus (SFG).&#xD;
Other Name: rTMS (active stimulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS on PPC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: repetitive transcranial magnetic stimulation (rTMS)&#xD;
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the posterior parietal cortex (PPC).&#xD;
Other Name: rTMS (active stimulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS on dlPFC</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Device: repetitive transcranial magnetic stimulation (rTMS)&#xD;
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the dorsolateral prefrontal cortex (dlPFC).&#xD;
Other Name: rTMS (active stimulation)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TMS on v5</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Device: repetitive transcranial magnetic stimulation (rTMS)&#xD;
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target visual cortex (v5).&#xD;
Other Name: rTMS (sham stimulation)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>repetitive transcranial magnetic stimulation (rTMS)</intervention_name>
    <description>A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.</description>
    <arm_group_label>TMS on PPC</arm_group_label>
    <arm_group_label>TMS on SFG</arm_group_label>
    <arm_group_label>TMS on dlPFC</arm_group_label>
    <arm_group_label>TMS on v5</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18-45 years old&#xD;
&#xD;
          -  Self-identified as male or female&#xD;
&#xD;
          -  English fluency;&#xD;
&#xD;
          -  Generally good health without cardiovascular, hepatic, renal, or autoimmune diseases;&#xD;
             diabetes; or cancer&#xD;
&#xD;
          -  Must have smoked for 1 year; smoke 10 cigarettes per day&#xD;
&#xD;
          -  Meeting DSM 5 criteria for Tobacco Use Disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Seeking treatment for nicotine dependence now or within 3 months before study entry&#xD;
&#xD;
          -  A medical condition that may compromise safety&#xD;
&#xD;
          -  A neurological disorder that would compromise compliance and/or informed consent&#xD;
&#xD;
          -  A major psychiatric disorder&#xD;
&#xD;
          -  Current drug use disorders other than Tobacco Use Disorder as defined by DSM 5&#xD;
&#xD;
          -  Recent use of drugs of abuse as shown by urine test at the screening or testing&#xD;
             sessions&#xD;
&#xD;
          -  Smoke marijuana more than once a week&#xD;
&#xD;
          -  Use of tobacco in forms other than cigarettes more than 10 days in last month&#xD;
&#xD;
          -  Preference for menthol&#xD;
&#xD;
          -  Pregnancy or nursing&#xD;
&#xD;
          -  Seizure disorder&#xD;
&#xD;
          -  Metal implants&#xD;
&#xD;
          -  Any other circumstance that the investigators determine would compromise safety&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Self-identified as male or female</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicole Petersen, Ph.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nicole Petersen, Ph.D</last_name>
    <phone>310-206-7438</phone>
    <email>npetersen@ucla.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Michael Apostol, B.A</last_name>
    <phone>760-803-0522</phone>
    <email>mapostol@mednet.ucla.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Semel Institute of Neuroscience</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90024</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicole Petersen, PhD</last_name>
      <phone>415-407-2364</phone>
      <email>npetersen@ucla.edu</email>
    </contact>
    <contact_backup>
      <last_name>Michael Apostol, BA</last_name>
      <phone>760-803-0522</phone>
      <email>mapostol@mednet.ucla.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>January 27, 2023</last_update_submitted>
  <last_update_submitted_qc>January 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, Los Angeles</investigator_affiliation>
    <investigator_full_name>Nicole Petersen</investigator_full_name>
    <investigator_title>Postdoctoral Fellow</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tobacco Use Disorder</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03827265
org study id: 18-000509
secondary id: 1K99DA045749-01
nct id: NCT03827265
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The purpose of this study is to determine if brain stimulation using repetitive transcranial
      magnetic stimulation (rTMS) directed at different parts of the brain can decrease feelings of
      cigarette craving and symptoms of cigarette withdrawal, and also if men and women have
      different responses to rTMS.

      Participants will visit the University of California, Los Angeles (UCLA) five times: First,
      for in-person screening, then for four rTMS sessions, four three different brain regions.
      Everyone in the study will be assigned to all four treatment arms and they will take place in
      a random order. Before and after each rTMS session, a brief MRI will be performed, and
      participants will be asked to fill out questionnaires that describe how they are feeling.
After the initial telephone screening, potentially eligible candidates will meet with staff
      and receive a lay-language explanation of the study. Candidates will review, ask about, and
      sign the informed consent form for the study. Those who have difficulty understanding the
      information will be able to review and ask questions to a staff member, who will help clarify
      the requirements, potential risks and benefits of participation. Any participant who is
      unable to demonstrate understanding of the information presented despite assistance will be
      excluded. Participants may withdraw from the study at any time. They may also be withdrawn at
      the discretion of the investigators for inability to comply with procedures or if continuing
      participation is unsafe or not in their best interest. Any participant expressing a desire
      for smoking cessation treatment, at any point during screening or while engaged in the study,
      will be referred to appropriate counseling services.

      Once the informed consent is obtained, participants will undergo a psychological evaluation
      (MINI) by trained study staff to rule out any exclusionary psychiatric diagnoses.
      Participants will provide a urine sample to be used for pregnancy and toxicology tests.

      They will complete a series of questionnaires to provide demographic information, and
      complete the Fagerström Test for Nicotine Dependence, Smoking History Questionnaire, Timeline
      Follow Back (TLFB) to report smoking over the month before testing, Substance Use Inventory,
      as well as the Beck Depression Inventory, Beck Anxiety Inventory, and Positive and Negative
      Affect Scale (PANAS) to measure mood state and traits before beginning the study. Daily
      smoker status will be tested at screening.

      Test Day Procedures:

        1. Evaluation of wakefulness. Due to the possibility that sleep deprivation may reduce the
           seizure threshold, wakefulness will be self-reported via the Stanford Sleepiness Scale.
           Participants who score below a 5 will be asked to reschedule their appointment and
           return when they are better rested.

        2. Abstinence from Drug and Alcohol Use. Each study will begin with a urine test to verify
           abstinence from drugs of abuse and a Breathalyzer test to verify abstinence from
           alcohol.

        3. Smoking Abstinence. Expired air will be sampled for CO to verify overnight abstinence.
           Participants who are not abstinent will be allowed to return for testing on another day.

        4. Pregnancy Testing. Female participants will each have a urine test to confirm absence of
           pregnancy.

        5. Self-report of Spontaneous Craving. Data will be obtained on the 10-item Urge to Smoke
           Scale. Self-reports for each item are given on a scale from 1-7, with 1 = definitely not
           and 7 = definitely.

        6. Self-report of Withdrawal. Participants will complete the Shiffman-Jarvik Withdrawal
           Scale, a 25-item questionnaire comprised of five scales: Craving; Psychological
           Withdrawal; Physiological Withdrawal; Stimulation/Sedation; and Appetite. Each question
           is rated on a 7-point scale (1 = definitely not to 7 = definitely) to indicate the
           respondent's feeling state. Scores are calculated as the mean response to each question
           on each particular subscale.

        7. Self-report of Mood. Participants will complete the Positive and Negative Affect
           Schedule (PANAS), a 20-item questionnaire comprising two mood scales (positive and
           negative). Each item is rated on a 5-point scale ranging from 1 (very slightly or not at
           all) to 5 (extremely) to indicate their feeling state.

        8. fMRI. Resting-state fMRI data will be collected while participants lie in the scanner
           with eyes open viewing a black screen. The scan duration is 8 minutes. Identical
           scanning procedures will be performed once before rTMS, and once after.

        9. rTMS. Subjects will first undergo Motor Threshold (MT) determination using single pulses
           applied to the left motor cortex, with motor response determined using electromyography
           (EMG) electrodes applied to the right hand (standard clinical procedures). On active
           test days, rTMS will be performed using 10 Hz stimulation, a treatment paradigm that has
           previously reduced craving, with 3000 pulses administered over 15 min at 100% MT with 5
           sec pulse trains and 10 sec inter-train interval. Participants will receive this
           stimulation to the left posterior parietal cortex, dorsolateral prefrontal cortex, and
           superior frontal gyrus on separate test days.

       10. Repeated self-reports of craving, withdrawal, and mood (items 4-6).

       11. Repeat fMRI.

      Study timeline:

      Each of the 4 TMS study visits will be scheduled at least 24 h apart to allow for washout.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Other
masking: Single (Participant)
masking description: This is a single-blind study and only the participant will not be aware of when they will be undergoing the sham stimulation arm.
measure: Repetitive Transcranial Magnetic Stimulation (rTMS)
time frame: 4 weeks
description: Data from the brain regions that will be targeted with repetitive transcranial magnetic stimulation (rTMS) will be used to assess changes in craving, withdrawal, and affect
measure: Urge to Smoke Questionnaire
time frame: 4 weeks
description: A 10-item self-report questionnaire used to measure spontaneous craving
measure: Shiffman-Jarvik Withdrawal Scale
time frame: 4 weeks
description: A 25-item self-report questionnaire used to measure withdrawal
measure: Positive and Negative Affect Schedule (PANAS)
time frame: 4 weeks
description: A 20-item questionnaire used to measure mood
measure: Baseline Magnetic Resonance Imaging (MRI)
time frame: 4 Weeks
description: Resting-state fMRI data will be collected before the TMS session
measure: Post-stimulation Magnetic Resonance Imaging (MRI)
time frame: 4 weeks
description: Resting-state fMRI data will be collected after the TMS session
arm group label: TMS on SFG
arm group type: Experimental
description: Device: repetitive transcranial magnetic stimulation (real)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the superior frontal gyrus (SFG).
Other Name: rTMS (active stimulation)
arm group label: TMS on PPC
arm group type: Experimental
description: Device: repetitive transcranial magnetic stimulation (rTMS)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the posterior parietal cortex (PPC).
Other Name: rTMS (active stimulation)
arm group label: TMS on dlPFC
arm group type: Experimental
description: Device: repetitive transcranial magnetic stimulation (rTMS)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target the dorsolateral prefrontal cortex (dlPFC).
Other Name: rTMS (active stimulation)
arm group label: TMS on v5
arm group type: Placebo Comparator
description: Device: repetitive transcranial magnetic stimulation (rTMS)
Transcranial magnetic stimulation (TMS) uses magnetic stimulation to change patterns of activity in your brain. This arm will target visual cortex (v5).
Other Name: rTMS (sham stimulation)
intervention type: Device
intervention name: repetitive transcranial magnetic stimulation (rTMS)
description: A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.
arm group label: TMS on PPC
arm group label: TMS on SFG
arm group label: TMS on dlPFC
arm group label: TMS on v5
criteria: 
gender: All
gender based: Yes
gender description: Self-identified as male or female
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Nicole Petersen, Ph.D
role: Principal Investigator
affiliation: Faculty
last name: Nicole Petersen, Ph.D
phone: 310-206-7438
email: npetersen@ucla.edu
last name: Michael Apostol, B.A
phone: 760-803-0522
email: mapostol@mednet.ucla.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, Los Angeles
investigator full name: Nicole Petersen
investigator title: Postdoctoral Fellow
mesh term: Tobacco Use Disorder