<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/NCT04409704</url>
  </required_header>
  <id_info>
    <org_study_id>11-0771</org_study_id>
    <nct_id>NCT04409704</nct_id>
  </id_info>
  <brief_title>Repetitive Transcranial Magnetic Stimulation of the DMPFC for Anorexia and Bulimia: an Open-Label Case Series</brief_title>
  <official_title>Repetitive Transcranial Magnetic Stimulation of the Dorsomedial Prefrontal Cortex as a Treatment for Anorexia Nervosa and Bulimia Nervosa: An Open-Label Case Series</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Health Network, Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Klarman Family Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Health Network, Toronto</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex&#xD;
      repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with&#xD;
      Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is&#xD;
      heavily implicated in the regulation of mood and affect, and has been suggested to be&#xD;
      involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might&#xD;
      lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by&#xD;
      improved regulation of mood and affect. Improvements in important areas of comorbidity might&#xD;
      allow for better response to intensive treatment for AN and BN, and reduce relapse rates&#xD;
      after such treatment. The DMPFC may be a more appropriate target for compared to the&#xD;
      Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in&#xD;
      the past. Our initial preliminary pilot work has noted unexpected and significant&#xD;
      improvements in some core ED symptoms (bingeing and purging) and in important areas of&#xD;
      comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have&#xD;
      allowed some treatment resistant patients to either complete intensive treatment or be&#xD;
      successful in maintaining their progress post intensive treatment. Subjects will receive up&#xD;
      to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via&#xD;
      psychometric measures, and pre and post fMRI.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2011</start_date>
  <completion_date type="Actual">December 7, 2015</completion_date>
  <primary_completion_date type="Actual">April 30, 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Eating Disorder Examination (EDE)</measure>
    <time_frame>Change from baseline to 1 week post-treatment completion.</time_frame>
    <description>Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Bulimia Nervosa</condition>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>10 Hz</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Repetitive Transcranial Magnetic Stimulation</intervention_name>
    <description>10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.</description>
    <arm_group_label>10 Hz</arm_group_label>
    <other_name>High-frequency rTMS</other_name>
    <other_name>Magventure DB80 Coil</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients will be included if they:&#xD;
&#xD;
          -  Are voluntary and competent to consent to treatment.&#xD;
&#xD;
          -  Have met DSM-5 diagnostic criteria for Anorexia Nervosa or Bulimia Nervosa, over the&#xD;
             last 6 months at minimum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients will be excluded if they have:&#xD;
&#xD;
          1. Past or current neurological illness&#xD;
&#xD;
          2. Comorbid schizophrenia&#xD;
&#xD;
          3. Current suicidal intent or plan&#xD;
&#xD;
          4. Contraindications to MRI or rTMS (e.g., metallic implants/foreign bodies)&#xD;
&#xD;
          5. Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan Downar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Blake Woodside, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Health Network, Toronto</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Eating Disorders</keyword>
  <keyword>rTMS</keyword>
  <keyword>Anorexia</keyword>
  <keyword>Bulimia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Bulimia</mesh_term>
    <mesh_term>Anorexia Nervosa</mesh_term>
    <mesh_term>Bulimia Nervosa</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04409704
org study id: 11-0771
nct id: NCT04409704
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This project proposes to perform a pilot study of fMRI targeted Dorsomedial Prefrontal Cortex
      repetitive transcranial magnetic stimulation (DMPFC-rTMS) on individuals diagnosed with
      Bulimia Nervosa (BN) and Anorexia Nervosa (AN). The DMFPC is a novel target for rTMS, is
      heavily implicated in the regulation of mood and affect, and has been suggested to be
      involved in AN, BN, major depression, OCD, and PTSD. Improved function in this area might
      lead to reduced AN and BN symptoms, such as bingeing, purging, and over-activity, perhaps by
      improved regulation of mood and affect. Improvements in important areas of comorbidity might
      allow for better response to intensive treatment for AN and BN, and reduce relapse rates
      after such treatment. The DMPFC may be a more appropriate target for compared to the
      Dorsolateral Prefrontal Cortex (DLPFC), which has typically been the focus of stimulation in
      the past. Our initial preliminary pilot work has noted unexpected and significant
      improvements in some core ED symptoms (bingeing and purging) and in important areas of
      comorbidity (OCD and PTSD), along with expected improvements in mood. These changes have
      allowed some treatment resistant patients to either complete intensive treatment or be
      successful in maintaining their progress post intensive treatment. Subjects will receive up
      to 30 sessions of bilateral DMPFC-rTMS. Response will be evaluated clinically, via
      psychometric measures, and pre and post fMRI.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eating Disorder Examination (EDE)
time frame: Change from baseline to 1 week post-treatment completion.
description: Weekly Binge/Purge Frequency on Eating Disorder Examination (EDE), a semi-structured interview assessing the full range of the specific psychopathology of eating disorders.
arm group label: 10 Hz
arm group type: Experimental
description: 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week for 4-6 weeks
intervention type: Device
intervention name: Repetitive Transcranial Magnetic Stimulation
description: 10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.
arm group label: 10 Hz
other name: High-frequency rTMS
other name: Magventure DB80 Coil
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Jonathan Downar, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
last name: Blake Woodside, MD
role: Principal Investigator
affiliation: University Health Network, Toronto
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Bulimia
mesh term: Anorexia Nervosa
mesh term: Bulimia Nervosa
sharing ipd: No