<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/NCT01678014</url>
  </required_header>
  <id_info>
    <org_study_id>DBSAN</org_study_id>
    <nct_id>NCT01678014</nct_id>
  </id_info>
  <brief_title>Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa</brief_title>
  <official_title>Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and&#xD;
      young adult women. There are many methods in the treatment of AN, such as family therapy,&#xD;
      cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are&#xD;
      refractory to all current medical treatment and never fully recover and the standardized&#xD;
      mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia,&#xD;
      stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and&#xD;
      capsulotomy are the most used methods which has been proved effective in obsessive and&#xD;
      compulsive disorders, depression and other psychiatric disorders. Many case reports indicate&#xD;
      that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there&#xD;
      are some common pathways between AN and other psychiatric disorder. The investigators have a&#xD;
      hypothesis that deep brain stimulation and capsulotomy may be promising methods in the&#xD;
      treatment of AN.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and&#xD;
      young adult women. Although the etiology of AN is still unclear, it is unanimous that social,&#xD;
      genetic and psychological factors appear to be involved in the onset and maintenance of this&#xD;
      disorder. There are many methods in the treatment of AN, such as family therapy, cognitive&#xD;
      behavioral therapy, psychotherapy and so on. However, almost 50% of patients are refractory&#xD;
      to all current medical treatment and never fully recover and the standardized mortality ratio&#xD;
      over the first 10 years is about 10%. For treatment-refractory anorexia, stereotactic&#xD;
      functional neurosurgery may be the better choice. Neurosurgery has been used in the treatment&#xD;
      of mental diseases for more than fifty years. Deep brain stimulation and capsulotomy are the&#xD;
      most used methods which has been proved effective in obsessive and compulsive disorders,&#xD;
      depression and other psychiatric disorders. Many case reports indicate that deep brain&#xD;
      stimulation or capsulotomy may be effective in the treatment of AN. As there are some common&#xD;
      pathways between AN and other psychiatric disorders. The investigators have a hypothesis that&#xD;
      deep brain stimulation and capsulotomy may be promising methods in the treatment of AN.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Anticipated">October 2012</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>Anorexia Related Preoccupations and Rituals</measure>
    <time_frame>April 2012-April 2014</time_frame>
    <description>Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Anorexia</condition>
  <arm_group>
    <arm_group_label>Anorexia</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Anorexia patients</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Deep Brain Stimulation(DBS)</intervention_name>
    <description>Deep Brain Stimulation(DBS)is a neurosurgical procedure which include the implantation of deep brain electrodes and the connect to an implantable pulse generator (IPG) that is implanted below the collarbone.</description>
    <arm_group_label>Anorexia</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Capsulotomy</intervention_name>
    <arm_group_label>Anorexia</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The age was between 18 to 60 years old.&#xD;
&#xD;
          2. Diagnosis of Anorexia Nervosa by the Diagnostic and Statistical Manual (DSM-IVR)&#xD;
&#xD;
          3. Able to comply with all testing, follow-ups and study appointments and protocols.&#xD;
&#xD;
          4. Treatment Resistance is defined by some or all of:&#xD;
&#xD;
               -  The duration of AN was more than 3 years and no period of good function.&#xD;
&#xD;
               -  The disorder severely affected the quality of life of the patient, preventing&#xD;
                  participation in normal activities such as work or study.&#xD;
&#xD;
               -  Chronic stable AN lasting at least 10 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with obviously encephalatrophy which was confirmed by MRI.&#xD;
&#xD;
          2. Patients who were alcohol or substance dependence or abuse in the last 6 months.&#xD;
&#xD;
          3. Patients who can not undergo the Magnetic Resonance Imaging (MRI) or Positron Emission&#xD;
             Tomography (PET) scanning&#xD;
&#xD;
          4. patients can not complete the 12 months follow-up.&#xD;
&#xD;
          5. Patients with severe heart diseases or other organic problem who could not undergo the&#xD;
             neurosurgery.&#xD;
&#xD;
          6. Pregnancy&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bomin Sun, MD</last_name>
    <role>Study Director</role>
    <affiliation>Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wei Liu, MD</last_name>
    <phone>64370045</phone>
    <phone_ext>632068</phone_ext>
    <email>doctorliuwei@yahoo.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ruijin Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bomin Sun, MD</last_name>
      <phone>64370045</phone>
      <phone_ext>632001</phone_ext>
      <email>bominsun@sh163.net</email>
    </contact>
    <investigator>
      <last_name>Wei Liu, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <link>
    <url>http://www.rjh.com.cn/pages/index.shtml</url>
    <description>Related Info</description>
  </link>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>September 1, 2012</last_update_submitted>
  <last_update_submitted_qc>September 1, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 5, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Wei Liu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Anorexia</keyword>
  <keyword>DBS</keyword>
  <keyword>Capsulotomy</keyword>
  <keyword>Signs and Symptoms</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anorexia</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/NCT01678014
org study id: DBSAN
nct id: NCT01678014
lead sponsor: 
has dmc: Yes
Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and
      young adult women. There are many methods in the treatment of AN, such as family therapy,
      cognitive behavioral therapy, psychotherapy and so on. However, almost 50% of patients are
      refractory to all current medical treatment and never fully recover and the standardized
      mortality ratio over the first 10 years is about 10%. For treatment-refractory anorexia,
      stereotactic functional neurosurgery may be the better choice. Deep brain stimulation and
      capsulotomy are the most used methods which has been proved effective in obsessive and
      compulsive disorders, depression and other psychiatric disorders. Many case reports indicate
      that deep brain stimulation or capsulotomy may be effective in the treatment of AN. As there
      are some common pathways between AN and other psychiatric disorder. The investigators have a
      hypothesis that deep brain stimulation and capsulotomy may be promising methods in the
      treatment of AN.
Anorexia nervosa (AN) is a serious eating disorder mostly affecting adolescent girls and
      young adult women. Although the etiology of AN is still unclear, it is unanimous that social,
      genetic and psychological factors appear to be involved in the onset and maintenance of this
      disorder. There are many methods in the treatment of AN, such as family therapy, cognitive
      behavioral therapy, psychotherapy and so on. However, almost 50% of patients are refractory
      to all current medical treatment and never fully recover and the standardized mortality ratio
      over the first 10 years is about 10%. For treatment-refractory anorexia, stereotactic
      functional neurosurgery may be the better choice. Neurosurgery has been used in the treatment
      of mental diseases for more than fifty years. Deep brain stimulation and capsulotomy are the
      most used methods which has been proved effective in obsessive and compulsive disorders,
      depression and other psychiatric disorders. Many case reports indicate that deep brain
      stimulation or capsulotomy may be effective in the treatment of AN. As there are some common
      pathways between AN and other psychiatric disorders. The investigators have a hypothesis that
      deep brain stimulation and capsulotomy may be promising methods in the treatment of AN.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Anorexia Related Preoccupations and Rituals
time frame: April 2012-April 2014
description: Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
arm group label: Anorexia
arm group type: Experimental
description: Anorexia patients
intervention type: Procedure
intervention name: Deep Brain Stimulation(DBS)
description: Deep Brain Stimulation(DBS)is a neurosurgical procedure which include the implantation of deep brain electrodes and the connect to an implantable pulse generator (IPG) that is implanted below the collarbone.
arm group label: Anorexia
intervention type: Procedure
intervention name: Capsulotomy
arm group label: Anorexia
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Bomin Sun, MD
role: Study Director
affiliation: Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
last name: Wei Liu, MD
phone: 64370045
phone ext: 632068
email: doctorliuwei@yahoo.cn
facility: 
status: Recruiting
contact: 
investigator: 
country: China
url: http://www.rjh.com.cn/pages/index.shtml
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Wei Liu
investigator title: Principal Investigator
mesh term: Anorexia