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

NCT ID: NCT01678014

Last Updated: 2012-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-12-31

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.

Conditions

Anorexia

Keywords

Anorexia; DBS; Capsulotomy; Signs and Symptoms

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Anorexia

Anorexia patients

Group Type: EXPERIMENTAL

Deep Brain Stimulation(DBS)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Interventions

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.

Intervention Type: PROCEDURE

Capsulotomy

Intervention Type: PROCEDURE

Eligibility 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

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Wei Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bomin Sun, MD

Role: STUDY_DIRECTOR

Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wei Liu, MD

Role: CONTACT

Phone: 64370045

Email: doctorliuwei@yahoo.cn

Facility Contacts

Bomin Sun, MD

Role: primary

Other Identifiers

DBSAN

Identifier Type: -

Identifier Source: org_study_id