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Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa

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ClinicalTrials.gov Identifier: NCT01678014
Recruitment Status : Unknown
Verified September 2012 by Wei Liu, Ruijin Hospital.
Recruitment status was:  Recruiting
First Posted : September 3, 2012
Last Update Posted : September 5, 2012
Sponsor:
Information provided by (Responsible Party):
Wei Liu, Ruijin Hospital

Tracking Information
First Submitted Date  ICMJE August 30, 2012
First Posted Date  ICMJE September 3, 2012
Last Update Posted Date September 5, 2012
Study Start Date  ICMJE April 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2012)
Anorexia Related Preoccupations and Rituals [ Time Frame: April 2012-April 2014 ]
Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
Official Title  ICMJE Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Anorexia
Intervention  ICMJE
  • Procedure: Deep Brain Stimulation(DBS)
    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.
  • Procedure: Capsulotomy
Study Arms  ICMJE Experimental: Anorexia
Anorexia patients
Interventions:
  • Procedure: Deep Brain Stimulation(DBS)
  • Procedure: Capsulotomy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 31, 2012)
48
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date October 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. The age was between 18 to 60 years old.
  2. Diagnosis of Anorexia Nervosa by the Diagnostic and Statistical Manual (DSM-IVR)
  3. Able to comply with all testing, follow-ups and study appointments and protocols.
  4. Treatment Resistance is defined by some or all of:

    • The duration of AN was more than 3 years and no period of good function.
    • The disorder severely affected the quality of life of the patient, preventing participation in normal activities such as work or study.
    • Chronic stable AN lasting at least 10 years.

Exclusion Criteria:

  1. Patients with obviously encephalatrophy which was confirmed by MRI.
  2. Patients who were alcohol or substance dependence or abuse in the last 6 months.
  3. Patients who can not undergo the Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
  4. patients can not complete the 12 months follow-up.
  5. Patients with severe heart diseases or other organic problem who could not undergo the neurosurgery.
  6. Pregnancy

    -

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678014
Other Study ID Numbers  ICMJE DBSAN
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Wei Liu, Ruijin Hospital
Original Responsible Party Wei Liu, Ruijin Hospital, Resident
Current Study Sponsor  ICMJE Ruijin Hospital
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bomin Sun, MD Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
PRS Account Ruijin Hospital
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP