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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

Study Description
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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.

Condition or disease Intervention/treatment Phase
Anorexia Procedure: Deep Brain Stimulation(DBS) Procedure: Capsulotomy Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia
Study Start Date : April 2012
Estimated Primary Completion Date : October 2012
Estimated Study Completion Date : December 2012
Arms and Interventions
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Arm Intervention/treatment
Experimental: Anorexia
Anorexia patients
 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678014


Contacts
Contact: Wei Liu, MD 64370045 ext 632068 doctorliuwei@yahoo.cn

Locations
China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China, 200025
Contact: Bomin Sun, MD    64370045 ext 632001    bominsun@sh163.net   
Principal Investigator: Wei Liu, MD         
Sponsors and Collaborators
Ruijin Hospital
Investigators
Study Director: Bomin Sun, MD Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site
Related Info  This link exits the ClinicalTrials.gov site

Responsible Party: Wei Liu, Principal Investigator, Ruijin Hospital
ClinicalTrials.gov Identifier: NCT01678014     History of Changes
Other Study ID Numbers: DBSAN
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: September 5, 2012
Last Verified: September 2012

Keywords provided by Wei Liu, Ruijin Hospital:
Anorexia
DBS
Capsulotomy
Signs and Symptoms

Additional relevant MeSH terms:
Anorexia
Signs and Symptoms, Digestive
Signs and Symptoms