Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
Primary Purpose
Anorexia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Deep Brain Stimulation(DBS)
Capsulotomy
Sponsored by
About this trial
This is an interventional treatment trial for Anorexia focused on measuring Anorexia, DBS, Capsulotomy, Signs and Symptoms
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
-
Sites / Locations
- Ruijin HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anorexia
Arm Description
Anorexia patients
Outcomes
Primary Outcome Measures
Anorexia Related Preoccupations and Rituals
Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01678014
Brief Title
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
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia
Keywords
Anorexia, DBS, Capsulotomy, Signs and Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anorexia
Arm Type
Experimental
Arm Description
Anorexia patients
Intervention Type
Procedure
Intervention Name(s)
Deep Brain Stimulation(DBS)
Intervention Description
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
Intervention Name(s)
Capsulotomy
Primary Outcome Measure Information:
Title
Anorexia Related Preoccupations and Rituals
Description
Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
Time Frame
April 2012-April 2014
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Liu, MD
Phone
64370045
Ext
632068
Email
doctorliuwei@yahoo.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD
Organizational Affiliation
Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Ruijin Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bomin Sun, MD
Phone
64370045
Ext
632001
Email
bominsun@sh163.net
First Name & Middle Initial & Last Name & Degree
Wei Liu, MD
12. IPD Sharing Statement
Links:
URL
http://www.rjh.com.cn/pages/index.shtml
Description
Related Info
Learn more about this trial
Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
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