<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/NCT03813355</url>
  </required_header>
  <id_info>
    <org_study_id>1708195</org_study_id>
    <secondary_id>2018-A02866-49</secondary_id>
    <nct_id>NCT03813355</nct_id>
  </id_info>
  <brief_title>Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa</brief_title>
  <acronym>EVASTRAM</acronym>
  <official_title>Evaluation of tDCS Efficacy in Enduring Anorexia Nervosa : a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Approximately 20% of anorexia nervosa cases do not respond to conventional management&#xD;
      strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... -&#xD;
      whether they are applied outpatients or during very long hospitalizations. These situations&#xD;
      of chronic evolution are characterized by a high rate of mortality. Brain stimulation could&#xD;
      be an alternative therapy for these patients. tDCS (transcranial direct current stimulation)&#xD;
      is a non-invasive stimulation technique that has demonstrated beneficial effects in other&#xD;
      psychiatric conditions such as major depression or schizophrenia.&#xD;
&#xD;
      The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa&#xD;
      resistant to conventional treatments on weight gain, eating behavior, psychological and&#xD;
      nutritional behavioral scales, cognition, connectivity and brain activity.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    lack of inclusion to meet the evaluation criteria&#xD;
  </why_stopped>
  <start_date type="Actual">October 21, 2020</start_date>
  <completion_date type="Actual">July 13, 2022</completion_date>
  <primary_completion_date type="Actual">May 4, 2022</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Body Mass Index (BMI)</measure>
    <time_frame>weeks 8</time_frame>
    <description>Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m^2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Eating Disorder Inventory (EDI)</measure>
    <time_frame>weeks 8</time_frame>
    <description>Change in Eating Disorder Inventory scale after stimulation sessions&#xD;
EDI measures :&#xD;
Drive for thinness (score between 0-4)&#xD;
Bulimia (score between 0-5)&#xD;
Body dissatisfaction (score between 3-10)&#xD;
ineffectiveness (score between 0-6)&#xD;
Perfectionism (score between 0-5)&#xD;
Interpersonal Distrust (score between 0-6)&#xD;
Interoceptive awareness (score between 0-4)&#xD;
Maturity Fears (score between 0-6)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dutch Eating Behavior Questionnaire (DEBQ)</measure>
    <time_frame>weeks 8</time_frame>
    <description>Change in Dutch Eating Behavior Questionnaire (DEBQ) after stimulation sessions&#xD;
DEBQ measures :&#xD;
Restrained eating (score between 10-30)&#xD;
Emotional eating (score between 17-35)&#xD;
external eating (score between 20-40)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Beck Depression Inventory (BDI)</measure>
    <time_frame>weeks 8</time_frame>
    <description>Change in Beck Depression Inventory after stimulation sessions.&#xD;
BDI measures :&#xD;
No depression : score between 0-9&#xD;
midl depression or anxiety : score between 10-19&#xD;
moderate depression or anxiety : score between 20-25&#xD;
moderate to severe depression or anxiety : score between 26-29&#xD;
severe depression or anxiety : score between 30-40&#xD;
very severe depression or anxiety : score between 41-84</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State-Trait Anxiety Inventory (STAI)</measure>
    <time_frame>weeks 8</time_frame>
    <description>Change in State-Trait Anxiety Inventory (STAI) after stimulation sessions&#xD;
STAI measures :&#xD;
no anxiety : score between 0-19&#xD;
very low anxiety : score between 36-45&#xD;
low anxiety : score between 46-55&#xD;
moderate anxiety : score between 56-65&#xD;
high anxiety : score between 56-65&#xD;
very high anxiety : score greater than 65</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Active stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial Direct Current Stimulation (tDCS)</intervention_name>
    <description>transcranial Direct Current Stimulation (tDCS) during 20 sessions</description>
    <arm_group_label>Active stimulation</arm_group_label>
    <arm_group_label>Sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 anorexia nervosa&#xD;
             criteria&#xD;
&#xD;
          -  Body Mass Index (BMI) &lt; 17kg/m2&#xD;
&#xD;
          -  Conventional treatment failure over the last 12 months&#xD;
&#xD;
          -  Refusal or no indication of artificial nutrition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Artificial nutrition&#xD;
&#xD;
          -  Other chronic diseases&#xD;
&#xD;
          -  drug use (except tobacco)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  Edinburgh score &lt; 14&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Catherine Massoubre, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Grenoble</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon</name>
      <address>
        <city>Lyon</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 23, 2019</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>brain stimulation</keyword>
  <keyword>Body Mass Index</keyword>
  <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>
  <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/NCT03813355
org study id: 1708195
secondary id: 2018-A02866-49
nct id: NCT03813355
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Approximately 20% of anorexia nervosa cases do not respond to conventional management
      strategies: cognitive behavioral therapy, weight gain contract, drug treatments, etc ... -
      whether they are applied outpatients or during very long hospitalizations. These situations
      of chronic evolution are characterized by a high rate of mortality. Brain stimulation could
      be an alternative therapy for these patients. tDCS (transcranial direct current stimulation)
      is a non-invasive stimulation technique that has demonstrated beneficial effects in other
      psychiatric conditions such as major depression or schizophrenia.

      The objectives of the study will be to evaluate the efficacy of tDCS in anorexia nervosa
      resistant to conventional treatments on weight gain, eating behavior, psychological and
      nutritional behavioral scales, cognition, connectivity and brain activity.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Body Mass Index (BMI)
time frame: weeks 8
description: Change in body mass index after stimulation sessions. Weight and Height will be combined to report BMI in kg/m^2
measure: Eating Disorder Inventory (EDI)
time frame: weeks 8
description: Change in Eating Disorder Inventory scale after stimulation sessions
EDI measures :
Drive for thinness (score between 0-4)
Bulimia (score between 0-5)
Body dissatisfaction (score between 3-10)
ineffectiveness (score between 0-6)
Perfectionism (score between 0-5)
Interpersonal Distrust (score between 0-6)
Interoceptive awareness (score between 0-4)
Maturity Fears (score between 0-6)
measure: Dutch Eating Behavior Questionnaire (DEBQ)
time frame: weeks 8
description: Change in Dutch Eating Behavior Questionnaire (DEBQ) after stimulation sessions
DEBQ measures :
Restrained eating (score between 10-30)
Emotional eating (score between 17-35)
external eating (score between 20-40)
measure: Beck Depression Inventory (BDI)
time frame: weeks 8
description: Change in Beck Depression Inventory after stimulation sessions.
BDI measures :
No depression : score between 0-9
midl depression or anxiety : score between 10-19
moderate depression or anxiety : score between 20-25
moderate to severe depression or anxiety : score between 26-29
severe depression or anxiety : score between 30-40
very severe depression or anxiety : score between 41-84
measure: State-Trait Anxiety Inventory (STAI)
time frame: weeks 8
description: Change in State-Trait Anxiety Inventory (STAI) after stimulation sessions
STAI measures :
no anxiety : score between 0-19
very low anxiety : score between 36-45
low anxiety : score between 46-55
moderate anxiety : score between 56-65
high anxiety : score between 56-65
very high anxiety : score greater than 65
arm group label: Active stimulation
arm group type: Experimental
description: Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with active stimulations
arm group label: Sham stimulation
arm group type: Sham Comparator
description: Brain stimulation by Transcranial Direct Current Stimulation (tDCS) with inactive stimulations
intervention type: Device
intervention name: transcranial Direct Current Stimulation (tDCS)
description: transcranial Direct Current Stimulation (tDCS) during 20 sessions
arm group label: Active stimulation
arm group label: Sham stimulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Catherine Massoubre, PhD
role: Principal Investigator
affiliation: CHU Saint-Etienne
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa
sharing ipd: No