<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/NCT03273205</url>
  </required_header>
  <id_info>
    <org_study_id>1955/16 S-IV</org_study_id>
    <nct_id>NCT03273205</nct_id>
  </id_info>
  <brief_title>Transcranial Direct Current Stimulation (tDCS) in the Treatment of Anorexia Nervosa</brief_title>
  <acronym>SANO</acronym>
  <official_title>The Changes in the Body-perception and Perception of the Pain in Patients With Anorexia Nervosa Before and After Using the tDCS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Silvie Ceresnakova</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Charles University, Czech Republic</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>
      Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an&#xD;
      extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness.&#xD;
      The treatment is very difficult and not always effective. That´s the reason why we are&#xD;
      looking for new ways of the therapeutic approach.&#xD;
&#xD;
      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which&#xD;
      modulates the neuronal excitability. According to previous research it has a potential to&#xD;
      help people with Anorexia Nervosa.&#xD;
&#xD;
      The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the&#xD;
      inhibitory one). We put them on the skull into the different positions, in dependence on the&#xD;
      fact, if we want to excite or on to inhibit the parts of the brain under the electrodes.&#xD;
&#xD;
      There are several hypothesis how could the tDCS help in patients with AN. One of them speaks&#xD;
      about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the&#xD;
      anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in&#xD;
      resetting the inter-hemispheric balance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stimulation of 2 milliampere is applied for 30 minutes in every real session. Together there&#xD;
      are 10 sessions, the application is every workday within 2 weeks.&#xD;
&#xD;
      All measurements and questionnaires are made 4 times:&#xD;
&#xD;
        1. Before the stimulation&#xD;
&#xD;
        2. On the day of the last stimulation&#xD;
&#xD;
        3. 14 days after the last stimulation&#xD;
&#xD;
        4. 28 days after the last stimulation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Actual">February 1, 2021</completion_date>
  <primary_completion_date type="Actual">April 1, 2020</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>Change of the Eating Disorders Examination Questionnaire (EDEq) score</measure>
    <time_frame>8 weeks</time_frame>
    <description>Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the Zung Self-Rating Depression Scale</measure>
    <time_frame>8 weeks</time_frame>
    <description>Comparison of the total scores of the Zung Self-Rating Depression Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the pain threshold</measure>
    <time_frame>8 weeks</time_frame>
    <description>Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the weight in kilograms</measure>
    <time_frame>8 weeks</time_frame>
    <description>Regularly weighting on the scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">43</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Anodal tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The first group of patients has the real stimulation and the electrodes are placed in this position:&#xD;
Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The second group has the sham stimulation, but the electrodes are placed in the same position as in the first group:&#xD;
Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Anodal tDCS</intervention_name>
    <description>This group gets a real stimulation</description>
    <arm_group_label>Anodal tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham tDCS</intervention_name>
    <description>This group gets a sham stimulation</description>
    <arm_group_label>Sham tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with the diagnosis of anorexia nervosa&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients: with the diagnosis of epilepsy, after a serious injury of head, with chronic&#xD;
             headache, with some metal or electronic implants in their heads and patients who are&#xD;
             pregnant.&#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>Hana Papezova, Prof.,M.D.,CSc.</last_name>
    <role>Study Director</role>
    <affiliation>Department of Psychiatry, Charles University in Prague and General University Hospital in Prague</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Psychiatry, Charles University in Prague and General University Hospital in Prague</name>
      <address>
        <city>Prague</city>
        <zip>121 08</zip>
        <country>Czechia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Czechia</country>
  </location_countries>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>February 16, 2021</last_update_submitted>
  <last_update_submitted_qc>February 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Charles University, Czech Republic</investigator_affiliation>
    <investigator_full_name>Silvie Ceresnakova</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Transcranial direct current stimulation (tDCS)</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>
  <!-- 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/NCT03273205
org study id: 1955/16 S-IV
nct id: NCT03273205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Anorexia Nervosa (AN) is a serious and often chronical eating disorder characterized by an
      extreme effort for weight loss and intense fear of becoming fat despite the obvious thinness.
      The treatment is very difficult and not always effective. That´s the reason why we are
      looking for new ways of the therapeutic approach.

      Transcranial direct current stimulation (tDCS) is a neuromodulation technique, which
      modulates the neuronal excitability. According to previous research it has a potential to
      help people with Anorexia Nervosa.

      The device for the tDCS has two electrodes, an anode (the excitatory one) and a cathode (the
      inhibitory one). We put them on the skull into the different positions, in dependence on the
      fact, if we want to excite or on to inhibit the parts of the brain under the electrodes.

      There are several hypothesis how could the tDCS help in patients with AN. One of them speaks
      about the hyperactivity of the right hemisphere in Anorexia Nervosa. Therefore could the
      anodal (excitatory) tDCS over the left hemisphere and the cathodal (inhibitory one) help in
      resetting the inter-hemispheric balance.
Stimulation of 2 milliampere is applied for 30 minutes in every real session. Together there
      are 10 sessions, the application is every workday within 2 weeks.

      All measurements and questionnaires are made 4 times:

        1. Before the stimulation

        2. On the day of the last stimulation

        3. 14 days after the last stimulation

        4. 28 days after the last stimulation
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change of the Eating Disorders Examination Questionnaire (EDEq) score
time frame: 8 weeks
description: Comparison of the total scores and subscores of the Eating Disorders Examination Questionnaire (EDEq)
measure: Change of the Zung Self-Rating Depression Scale
time frame: 8 weeks
description: Comparison of the total scores of the Zung Self-Rating Depression Scale
measure: Change of the pain threshold
time frame: 8 weeks
description: Measurement of the pain threshold with the TSA II Neuro Sensory Analyzer
measure: Change of the weight in kilograms
time frame: 8 weeks
description: Regularly weighting on the scale
arm group label: Anodal tDCS
arm group type: Experimental
description: The first group of patients has the real stimulation and the electrodes are placed in this position:
Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2)
arm group label: Sham tDCS
arm group type: Sham Comparator
description: The second group has the sham stimulation, but the electrodes are placed in the same position as in the first group:
Anode: Left DLPFC [F3) Cathode: Right Supraorbital (FP2)
intervention type: Device
intervention name: Anodal tDCS
description: This group gets a real stimulation
arm group label: Anodal tDCS
intervention type: Device
intervention name: Sham tDCS
description: This group gets a sham stimulation
arm group label: Sham tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Hana Papezova, Prof.,M.D.,CSc.
role: Study Director
affiliation: Department of Psychiatry, Charles University in Prague and General University Hospital in Prague
facility: 
country: Czechia
responsible party type: Sponsor-Investigator
investigator affiliation: Charles University, Czech Republic
investigator full name: Silvie Ceresnakova
investigator title: Principal Investigator
mesh term: Anorexia
mesh term: Anorexia Nervosa