Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia Nervosa
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Anorexia |
Procedure: Deep Brain Stimulation(DBS) Procedure: Capsulotomy |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia |
- Anorexia Related Preoccupations and Rituals [ Time Frame: April 2012-April 2014 ] [ Designated as safety issue: No ]Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01678014
| Contact: Wei Liu, MD | 64370045 ext 632068 | doctorliuwei@yahoo.cn |
| China, Shanghai | |
| Ruijin Hospital | Recruiting |
| Shanghai, Shanghai, China, 200025 | |
| Contact: Bomin Sun, MD 64370045 ext 632001 bominsun@sh163.net | |
| Principal Investigator: Wei Liu, MD | |
| Study Director: | Bomin Sun, MD | Department of sterotactic and functional neurosurgery, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine |
More Information
Additional Information:
No publications provided
| Responsible Party: | Wei Liu, Principal Investigator, Ruijin Hospital |
| ClinicalTrials.gov Identifier: | NCT01678014 History of Changes |
| Other Study ID Numbers: | DBSAN |
| Study First Received: | August 30, 2012 |
| Last Updated: | September 1, 2012 |
| Health Authority: | China: Ethics Committee |
Keywords provided by Ruijin Hospital:
|
Anorexia DBS Capsulotomy Signs and Symptoms |
Additional relevant MeSH terms:
|
Anorexia Signs and Symptoms Signs and Symptoms, Digestive |
ClinicalTrials.gov processed this record on March 03, 2015