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

NCT01678014 | Unknown Phase 1 DMC

• 1 other identifier: DBSAN
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Anorexia

Keywords

Anorexia; DBS; Capsulotomy; Signs and Symptoms

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Anorexia

EXPERIMENTAL

Anorexia patients

Procedure: Deep Brain Stimulation(DBS); Procedure: Capsulotomy

Interventions

Deep Brain Stimulation(DBS) 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.

Anorexia

Capsulotomy PROCEDURE

Anorexia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The age was between 18 to 60 years old.
• Diagnosis of Anorexia Nervosa by the Diagnostic and Statistical Manual (DSM-IVR)
• Able to comply with all testing, follow-ups and study appointments and protocols.
• 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.

You may not qualify if:

• Patients with obviously encephalatrophy which was confirmed by MRI.
• Patients who were alcohol or substance dependence or abuse in the last 6 months.
• Patients who can not undergo the Magnetic Resonance Imaging (MRI) or Positron Emission Tomography (PET) scanning
• patients can not complete the 12 months follow-up.
• Patients with severe heart diseases or other organic problem who could not undergo the neurosurgery.
• Pregnancy

Sponsors & Collaborators

• Ruijin Hospital: lead

Study Sites (1)

Ruijin Hospital

Shanghai, Shanghai Municipality, 200025, China

RECRUITING

MeSH Terms

Conditions

Anorexia; Signs and Symptoms

Interventions

Deep Brain Stimulation; Posterior Capsulotomy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Surgical Procedures, Operative; Refractive Surgical Procedures; Ophthalmologic Surgical Procedures

Study Officials

• Bomin Sun, MD

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

  STUDY DIRECTOR

Central Study Contacts

Wei Liu, MD

CONTACT

64370045; doctorliuwei@yahoo.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2012
• First Posted: September 3, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2012
• Last Updated: September 5, 2012

Record last verified: 2012-09

Locations

CN (1)