NCT02254395Unknown1 期
PINS Stimulator System for Deep Brain Stimulation to Treat Obesity
适应症
干预措施
试验速览
- 阶段
- 1 期
- 入组人数
- 8
- 主要终点
- Body Weight
研究概览
简要总结
The purpose of this clinical study is to verify the long term effecacy and safety of a bilateral deep brain stimulation (DBS) produced by Beijing PINS Medical Co., Ltd. as a treatment option for patients with obesity.
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
- Double (Participant, 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
- 是
入选标准
- •Subject is aged 18 to
- •Body Mass Index [BMI] >40 kg/m2.
排除标准
- •Medical contraindications for general anesthesia, craniotomy, or DBS surgery
- •Evidence of neurological disorders, e.g., multiple sclerosis, Parkinson's disease and ischemic stroke, or severe brain atrophy or the presence of subdural hygromas or subdural hematomas.
- •Participate in other clinical trial;
- •Has a life expectancy of < 1 year.
- •The investigator and/or enrollment review committee, would preclude participation in the study.
研究组 & 干预措施
Deep Brain Stimulation
Experimental
Stimulation is on.
干预措施: Deep Brain Stimulation (Device)
Placebo
Sham Comparator
Sham Stimulation: Stimulation is off.
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
Body Weight
时间窗: 12 month
Body weight will be recorded at every follow-up visit.
次要结局
- Body Mass Index (BMI)(12 month)
- Food Intake(12 month)
研究者
相似试验
Unknown
1 期
PINS Stimulator System for Deep Brain Stimulation of the Nucleus Accumbens to Treat Severe Opioid AddictionOpioid AddictionNCT02282072Beijing Pins Medical Co., Ltd20
Unknown
4 期
Efficacy and Safety of DBS of the GPi in Patients With Primary Generalized and Segmental DystoniaDystoniaNCT00142259German Parkinson Study Group (GPS)40
招募中
不适用
Evaluation of Deep Brain Stimulation (DBS) of the Right Operculum 3 (OP3) in Permanent Non-pulsatile Disabling Tinnitus (TINNOP3-DBS)With or Without Hearing LossSevere Permanent Uni or Bilateral Non-pulsatile TinnitusResistant to Therapeutic FailureWithout Associated Vestibular PathologyNCT04296097University Hospital, Grenoble7
Unknown
不适用
Deep Brain Stimulation of the Anterior Nucleus of the Thalamus in Refractory EpilepsyRefractory EpilepsyNCT02602899Beijing Pins Medical Co., Ltd30
已完成
不适用
Deep Brain Stimulation for Patients With Dementia With Lewy BodiesDementia With Lewy BodiesNCT02263937University College, London6