Deep Brain Stimulation For Morbid, Treatment-Refractory, Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Percentage of excess weight loss
研究概览
简要总结
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option for obesity.
详细描述
The purpose of this clinical study is to investigate the safety and efficacy of deep brain stimulation (DBS) as a treatment option in the management of severe, treatment refractory, morbid obesity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 22 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 24 months post Roux-en-Y gastric bypass surgery without evidence of a sustained improvement in BMI after gastric bypass surgery for at least 6 months.
- •Participant is willing to comply with all follow-up evaluations at the specified times
- •Participant is able to provide informed consent
- •Fluent in English
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.
- •Severe cardiovascular, pulmonary, renal, liver, hematological disease, severe coagulopathy, acute infectious process
研究组 & 干预措施
DBS Surgery
All patients enrolled will undergo DBS implantation in the targeted region to assess the safety of the procedure and the efficacy through weight loss.
干预措施: Deep Brain Stimulation Device (Device)
结局指标
主要结局
Percentage of excess weight loss
时间窗: 2 years
The primary outcome measure at the conclusion of the study will be percent of excess weight loss (EWL).
次要结局
未报告次要终点
研究者
Ali Rezai, MD
Professor of Neurological Surgery
Ohio State University