Deep Brain Stimulation of Nucleus Accumbens/Anterior Limb of Internal Capsule to Prevent Treatment-Refractory Obsessive Compulsive Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10
- 主要终点
- Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
研究概览
简要总结
Nucleus accumbens/anterior limb of internal capsule play important roles in the process of treatment-refractory obsessive compulsive disorder, deep brain stimulation of nucleus accumbens/anterior limb of internal capsule will inhibit its activity and thus to effectively prevent the disorder.
详细描述
Obsessive-compulsive disorder (OCD) is characterized by obsessions (persistent thoughts) and compulsions (repetitive ritualistic behaviour). Core symptoms of OCD cause remarkable distress and often perceived as inappropriate. The prevalence of OCD in the general population is estimated between 1% and 3%. It is a psychiatric illness that can lead to chronic functional impairment. Treatment options for OCD include cognitive behavioural therapy (CBT) and/or pharmacotherapy. Even when the best treatment options are used, approximately 10% of these patients remain severely affected and are considered therapy-refractory resulting in marked suffering and impairment in self-care, work and social life. More recently, deep brain stimulation (DBS) has been investigated as a therapy for refractory OCD, and the procedure was granted a limited humanitarian device exemption by the FDA in 2009. For these patients, deep brain stimulation (DBS), a neurosurgical treatment that involves stereotactic implantation of electrodes in specific deep-seated brain regions, has emerged as a new treatment option.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of OCD following the diagnostic and statistical manual of mental disorders-fourth edition (DSM-IV) criteria for OCD;
- •Duration of illness: min. 5 year;
- •18 years old <Age <60 years old;
- •Severe form of OCD, as evidenced by: a score≥25 on the Y-BOCS, a score > 4 on the CGI scale, a score≤40 on the GAF ("global assessment of functioning).
- •All patients were lack of response to drug therapy after adequate administration (defined as more than 12 weeks at the maximum tolerated dose) of at least four different medications, lack of response to CBT (Cognitive Behaviour Therapy)over the course of 1 year of therapy or after 20 sessions.
- •Normal cognitive status and ability to understand and comply with instructions for multiple therapies.
- •Good overall health.
排除标准
- •Present or past history of psychotic symptoms.
- •Severe personality disorders;
- •Any clinically significant neurological disorder or medical illnesses affect ;
- •brain function, other than motor tics or Gilles de la Tourette syndrome;
- •Patient currently treated with anticoagulant or antiplatelet drug;
- •Patient with contraindication for surgery or anesthesia;
- •Inability to undergo awaked operation;
- •Infection, coagulopathy, significant cardiac or other medical risk factors for surgery;
- •Patient with contraindication for MRI scanning (cardiac pacemaker, pregnancy, metal in body, severe claustrophobia), abnormal brain MRI or serious inter current disease
研究组 & 干预措施
Deep Brain Stimulation
Continuous deep brain stimulation of bilateral nucleus accumbens
干预措施: Deep brain stimulation (Procedure)
Standard Control
Fluoxetine
干预措施: Fluoxetine (Drug)
结局指标
主要结局
Yale-Brown Obsessive Compulsive Scale (Y-BOCS)
时间窗: 6 month
次要结局
- The Hamilton Rating Scale for Depression (HAM-D)(6 month)
- Event related potentials(ERPs)(Baseline,3 month,6 month and 12 month)
- local field potential(LFP)(in surgery,7 days after surgery)
- Clinical Global Impression (CGI)(6 month)
- Global assessment of functioning (GAF)(6 month)
- The Hamilton Anxiety Scale (HAM-A)(6 month)
- Change in two static positron emission tomography(PET) images study(Baseline and 6month follow-up)
- Sheehan Disability Scale (SDS)(6 month)
研究者
Guodong Gao
Neurosurgery Department
Tang-Du Hospital