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.

Study Overview

• Status: Unknown
• Conditions: Anorexia
• Intervention / Treatment: Procedure: Deep Brain Stimulation(DBS); Procedure: Capsulotomy

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: Interventional
• Enrollment (Anticipated): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200025
      • Recruiting
      • Ruijin Hospital
      • Principal Investigator: Wei Liu, MD
      • Contact: Bomin Sun, MD; Phone Number: 632001 64370045; Email: bominsun@sh163.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Investigators: Study Director: Bomin Sun, MD, Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): October 1, 2012
• Study Completion (Anticipated): December 1, 2012

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: August 31, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Estimate): September 5, 2012
• Last Update Submitted That Met QC Criteria: September 1, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: Anorexia; Signs and Symptoms; DBS; Capsulotomy
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Anorexia
• Other Study ID Numbers: DBSAN