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

Anorexia Clinical Trial

Official title:

Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01678014
• Other study ID #: DBSAN
• Status: Recruiting
• Phase: Phase 1
• First received: August 30, 2012
• Last updated: September 1, 2012
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: Ruijin Hospital
• Contact: Wei Liu, MD
• Phone: 64370045
• Email: doctorliuwei[@]yahoo.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anorexia

Intervention

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.
• Capsulotomy

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anorexia Related Preoccupations and Rituals	Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months	April 2012-April 2014	No

External Links

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