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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by Ruijin Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Wei Liu, Ruijin Hospital
ClinicalTrials.gov Identifier:
NCT01678014
First received: August 30, 2012
Last updated: September 1, 2012
Last verified: September 2012

August 30, 2012
September 1, 2012
April 2012
October 2012   (final data collection date for primary outcome measure)
Anorexia Related Preoccupations and Rituals [ Time Frame: April 2012-April 2014 ] [ Designated as safety issue: No ]
Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
Same as current
Complete list of historical versions of study NCT01678014 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia

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.

Interventional
Phase 1
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Anorexia
  • 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
Experimental: Anorexia
Anorexia patients
Interventions:
  • Procedure: Deep Brain Stimulation(DBS)
  • Procedure: Capsulotomy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
48
December 2012
October 2012   (final data collection date for primary outcome measure)

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

    -

Both
18 Years to 60 Years
No
Contact: Wei Liu, MD 64370045 ext 632068 doctorliuwei@yahoo.cn
China
 
NCT01678014
DBSAN
Yes
Wei Liu, Ruijin Hospital
Ruijin Hospital
Not Provided
Study Director: Bomin Sun, MD Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Ruijin Hospital
September 2012

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