<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/NCT02263404</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-004</org_study_id>
    <nct_id>NCT02263404</nct_id>
  </id_info>
  <brief_title>PINS Stimulator System to Treat Severe Anorexia Nervosa</brief_title>
  <official_title>PINS Stimulator System to Treat Severe Anorexia Nervosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Pins Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beijing Tiantan Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beijing Pins Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of&#xD;
      effective treatments. AN becomes intractable in around 20%, resulting in huge individual and&#xD;
      healthcare costs. The study will help patients with severe AN using DBS. Individuals with&#xD;
      severe intractable AN will be eligible to take part in the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>Early 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 Related Preoccupations and Rituals</measure>
    <time_frame>Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hamilton Depression Rating Scale</measure>
    <time_frame>Change from baseline at 3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health Survey Short Form (SF-36)</measure>
    <time_frame>Change from baseline at 3 months, 6 months and 12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>Anorexia Nervosa</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <description>DBS Implant Stimulation</description>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <other_name>Rechargeable Neurostimulator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Female or male patients aged 20-60 years.&#xD;
&#xD;
          2. Diagnosis of anorexia nervosa, restricting or binge-purging subtype, as defi ned in&#xD;
             the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR).&#xD;
&#xD;
          3. Chronicity or treatment resistance shown by some or all of:&#xD;
&#xD;
               -  A pattern of 3 years' duration of relentless unresponsiveness to repeated&#xD;
                  voluntary hospital admissions, characterised by failure to complete treatment or&#xD;
                  immediate weight relapse after treatment.&#xD;
&#xD;
               -  A pattern of increasing medical instability, accompanied by refusal to&#xD;
                  participate in or a pattern of poor response to intensive expert treatment and&#xD;
                  increasing medical acuity, lasting at least 2 years and including at least two&#xD;
                  episodes of involuntary feeding.&#xD;
&#xD;
               -  A pattern of chronic stable anorexia nervosa that has lasted at least 10 years.&#xD;
&#xD;
               -  Able to provide informed consent.&#xD;
&#xD;
          4. Able to comply with all testing, follow-ups, and study appointments and protocols.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Person with consciousness disorder on opioid abstinence, seriously aggressive, heavily&#xD;
             dehydrated and intending to commit suicide.&#xD;
&#xD;
          2. Patients with serious liver and kidney dysfunction, pulmonary decompensation, or&#xD;
             complicated with serious damage in other systems.&#xD;
&#xD;
          3. Patients with serious infectious disease.&#xD;
&#xD;
          4. Patients with history of serious neurological or psychiatrical diseases.&#xD;
&#xD;
          5. Person with history of HIV infection or serious malnutrition.&#xD;
&#xD;
          6. Dependent upon and addicted to multiple drugs.&#xD;
&#xD;
          7. Any contraindication to MRI or PET scanning.&#xD;
&#xD;
          8. Body-mass index less than 13.&#xD;
&#xD;
          9. Attended some other trials within one year.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Luming, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tsinghua University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Fumin, PhD</last_name>
    <phone>+86 010-59361265</phone>
    <email>pins_medical@163.com</email>
  </overall_contact>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 27, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2016</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/NCT02263404
org study id: PINS-004
nct id: NCT02263404
lead sponsor: 
collaborator: 
has dmc: Yes
Anorexia Nervosa (AN) has the highest mortality of any psychiatric disorder and a paucity of
      effective treatments. AN becomes intractable in around 20%, resulting in huge individual and
      healthcare costs. The study will help patients with severe AN using DBS. Individuals with
      severe intractable AN will be eligible to take part in the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Eating Disorder Related Preoccupations and Rituals
time frame: Change from baseline in Eating Disorder Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
measure: Hamilton Depression Rating Scale
time frame: Change from baseline at 3 months, 6 months and 12 months
measure: Health Survey Short Form (SF-36)
time frame: Change from baseline at 3 months, 6 months and 12 months
arm group label: Deep Brain Stimulation
arm group type: Experimental
description: DBS Implant and stimulation Intervention: Device: Deep Brain Stimulation
intervention type: Device
intervention name: Deep Brain Stimulation
description: DBS Implant Stimulation
arm group label: Deep Brain Stimulation
other name: Rechargeable Neurostimulator
criteria: 
gender: All
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: No
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
last name: Jia Fumin, PhD
phone: +86 010-59361265
email: pins_medical@163.com
responsible party type: Sponsor
mesh term: Anorexia
mesh term: Anorexia Nervosa