Phase 1 Study of Deep Brain Stimulation and Capsulotomy for the Treatment of Refractory Anorexia
试验速览
- 阶段
- 1 期
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Anorexia Related Preoccupations and Rituals
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Anorexia
Anorexia patients
干预措施: Deep Brain Stimulation(DBS) (Procedure)
Anorexia
Anorexia patients
干预措施: Capsulotomy (Procedure)
结局指标
主要结局
Anorexia Related Preoccupations and Rituals
时间窗: April 2012-April 2014
Change from baseline in Anorexia Related Preoccupations and Rituals scores at 3 months, 6 months and 12 months
次要结局
未报告次要终点
研究者
Wei Liu
Principal Investigator
Ruijin Hospital