NCT02593695Unknown不适用
Deep Brain Stimulation of Nucleus Accumbens as a New Treatment to Treat Severe Anorexia Nervosa
Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- BMI
研究概览
简要总结
Anorexia nervosa (AN) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.Deep brain stimulation (DBS) may be a novel treatment in severe Anorexia nervosa.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years of age, male or female patients.
- •Diagnosis is Anorexia Nervosa(AN) by the DSMIV(Diagnostic and Statistical Manual of Mental Disorders Fourth Edition).
- •Long-term pharmacotherapy resistance.
- •Written informed consent.
- •normal intelligence and compliance
排除标准
- •Surgical contradiction（implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、DBS）or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions； History of brain trauma；
- •History of severe neuropsychiatric disease；
- •severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension；
- •Severe diabetes ,severe cardiovascular and cerebrovascular disease；
- •Malignant tumor；
- •Being using anticoagulant or showing clinical hemorrhagic tendency； Pregnant female；
- •Patients are taking part in other clinical trials in recent 3months； Being deem as unfit for the trials by researcher
结局指标
主要结局
BMI
时间窗: 6 month
次要结局
- weight(6 month)
- Yale-Brown Obsessive Compulsive Scale(6 month)
- Self-Rating Depression Scale(6 month)
- The Symptom Checklist-90(6 month)
研究者
Guodong Gao
Neurosurgery Department
Tang-Du Hospital
研究点 (1)
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