Clinical trial NCT01678014: Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
Official title: Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Anorexia
Keywords: Anorexia
DBS
Capsulotomy
Signs and Symptoms
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2012-09-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

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Primary outcomes:
measure: Anorexia Related Preoccupations and Rituals
timeFrame: April 2012-April 2014
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
state: Shanghai
Study officials:
affiliation: Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
name: Bomin Sun, MD
role: STUDY_DIRECTOR
References: