<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/NCT01717079</url>
  </required_header>
  <id_info>
    <org_study_id>2011/122/HP</org_study_id>
    <nct_id>NCT01717079</nct_id>
  </id_info>
  <brief_title>rTMS and Body Shape Perception</brief_title>
  <acronym>STIMOREX</acronym>
  <official_title>Effect of Transcranial Magnetic Stimulation on Disturbance of Body Shape Perception in Patients With Anorexia Nervosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <brief_summary>
    <textblock>
      Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder&#xD;
      characterized by a resistance to maintaining body weight at or above a minimally normal&#xD;
      weight for age and height, an intense fear of weight gain or being &quot;fat&quot; even though&#xD;
      underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in&#xD;
      the experience of body weight or shape. Body weight and shape dissatisfaction is linked to&#xD;
      the development, maintenance and relapse of AN. Neuroimaging studies have shown that the&#xD;
      inferior parietal cortex is involved in body image perception and less activated in patients&#xD;
      with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS)&#xD;
      is used to modulate cortical excitability, and particularly to increase excitability with&#xD;
      high-frequency rTMS. The aim of this study was to investigate the effect of &quot;excitatory&quot;&#xD;
      high-frequency rTMS over the &quot;hypoactive&quot; inferior parietal cortex of 54 patients with AN.&#xD;
&#xD;
      This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000&#xD;
      ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10&#xD;
      sessions in two weeks) versus placebo rTMS.&#xD;
&#xD;
      Assessments will be performed before rTMS and after the last rTMS session (immediately after,&#xD;
      at 15 days and three months). The principal criteria for judgement is a body image&#xD;
      satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement&#xD;
      are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating&#xD;
      Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating&#xD;
      scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis&#xD;
      using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker&#xD;
      for eating disorders recently described).&#xD;
&#xD;
      Inferior parietal cortex rTMS could not only improve body image perception, but also help in&#xD;
      the treatment of eating disorders, allowing weight gain with a decreased anxiety and&#xD;
      improving patients' quality of life. Also positive results could have direct therapeutic&#xD;
      implications with the possibility to complete regular rTMS sessions, or to implant extradural&#xD;
      electrodes for chronic parietal cortex stimulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Protocol stopped for safety reason&#xD;
  </why_stopped>
  <start_date type="Actual">May 2013</start_date>
  <completion_date type="Actual">December 15, 2017</completion_date>
  <primary_completion_date type="Actual">December 15, 2017</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>BSQ-34 scale (Body Shape Questionnaire)</measure>
    <time_frame>Just after rTMS</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>EAT-40 scale (eating attitude test)</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BULIT scale (bulimia test)</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EDI-2 scale (eating disorder inventory)</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hamilton scale</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The body mass index</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>body composition analysis using dual energy X-ray absorptiometry</measure>
    <time_frame>Before rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>autoantibodies against alpha-melanocyte stimulating hormone</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The adverse effects</measure>
    <time_frame>After rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Weight</measure>
    <time_frame>Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>BSQ-34 scale (Body Shape Questionnaire)</measure>
    <time_frame>Before rTMS, 15 days after rTMS and 3 months after rTMS</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Effective arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Effective coil</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo coil</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham rTMS</intervention_name>
    <description>120 pulses 0.2Hz</description>
    <arm_group_label>Placebo arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>rTMS</intervention_name>
    <description>120 pulses 0.2Hz</description>
    <arm_group_label>Effective arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female&#xD;
&#xD;
          -  Age above 18&#xD;
&#xD;
          -  Restrictive anorexia nervosa with a disease duration more than one year and less than&#xD;
             three years.&#xD;
&#xD;
          -  Body Mass Index below 16&#xD;
&#xD;
          -  Patient receiving or having received optimal treatment for anorexia nervosa&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Normal blood ionogramme&#xD;
&#xD;
          -  Previous stable antidepressor treatment for one month and no expected modification in&#xD;
             the three following months&#xD;
&#xD;
          -  Patients arriving by car with someone else or by public transportation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contraindication to transcranial magnetic stimulation i.e. pace-maker, cardiac valve&#xD;
             protheses, metallic protheses etc.&#xD;
&#xD;
          -  History of epileptic seizure&#xD;
&#xD;
          -  Cerebral lesion of any etiology (post-traumatic, tumoral, vascular etc.)&#xD;
&#xD;
          -  History of previous rTMS&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nathalie CHASTAN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Rouen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 29, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 30, 2012</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 30, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</mesh_term>
    <mesh_term>Anorexia Nervosa</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/NCT01717079
org study id: 2011/122/HP
nct id: NCT01717079
lead sponsor: 
Anorexia nervosa (AN) is a frequent, potentially life-threatening eating disorder
      characterized by a resistance to maintaining body weight at or above a minimally normal
      weight for age and height, an intense fear of weight gain or being "fat" even though
      underweight, a loss of menstrual periods in girls and women post-puberty and a disturbance in
      the experience of body weight or shape. Body weight and shape dissatisfaction is linked to
      the development, maintenance and relapse of AN. Neuroimaging studies have shown that the
      inferior parietal cortex is involved in body image perception and less activated in patients
      with AN compared with healthy subjects. Repetitive transcranial magnetic stimulation (rTMS)
      is used to modulate cortical excitability, and particularly to increase excitability with
      high-frequency rTMS. The aim of this study was to investigate the effect of "excitatory"
      high-frequency rTMS over the "hypoactive" inferior parietal cortex of 54 patients with AN.

      This randomized, double-blind, placebo-controlled study will compare effective rTMS (2000
      ten-Hz stimulations per session, applied at 90% of the resting motor threshold, with 10
      sessions in two weeks) versus placebo rTMS.

      Assessments will be performed before rTMS and after the last rTMS session (immediately after,
      at 15 days and three months). The principal criteria for judgement is a body image
      satisfaction scale (Boby Shape Questionnaire, BSQ-34). The secondary criteria for judgement
      are eating behaviour scales (Eating Attitude Test, EAT-40; Bulimia test, BULIT and Eating
      Disorders Inventory, EDI-2), the Hamilton depression rating scale and Hamilton anxiety rating
      scale, a quality of life scale (Short-Form Health Survey, SF-36), a body composition analysis
      using a Dual-energy X-ray absorptiometry and the alpha-MSH autoantibodies levels (biomarker
      for eating disorders recently described).

      Inferior parietal cortex rTMS could not only improve body image perception, but also help in
      the treatment of eating disorders, allowing weight gain with a decreased anxiety and
      improving patients' quality of life. Also positive results could have direct therapeutic
      implications with the possibility to complete regular rTMS sessions, or to implant extradural
      electrodes for chronic parietal cortex stimulation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: BSQ-34 scale (Body Shape Questionnaire)
time frame: Just after rTMS
measure: EAT-40 scale (eating attitude test)
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: BULIT scale (bulimia test)
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: EDI-2 scale (eating disorder inventory)
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: Hamilton scale
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMSBefore rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: Quality of Life Scale, MOS 36 Item Short-Form Health Survey or SF-36
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: The body mass index
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: body composition analysis using dual energy X-ray absorptiometry
time frame: Before rTMS and 3 months after rTMS
measure: autoantibodies against alpha-melanocyte stimulating hormone
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: The adverse effects
time frame: After rTMS
measure: Weight
time frame: Before rTMS, just after rTMS, 15 days after rTMS and 3 months after rTMS
measure: BSQ-34 scale (Body Shape Questionnaire)
time frame: Before rTMS, 15 days after rTMS and 3 months after rTMS
arm group label: Effective arm
arm group type: Active Comparator
description: Effective coil
arm group label: Placebo arm
arm group type: Placebo Comparator
description: Placebo coil
intervention type: Procedure
intervention name: Sham rTMS
description: 120 pulses 0.2Hz
arm group label: Placebo arm
intervention type: Procedure
intervention name: rTMS
description: 120 pulses 0.2Hz
arm group label: Effective arm
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Nathalie CHASTAN, MD
role: Principal Investigator
affiliation: UH Rouen
facility: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa