Deep Brain Stimulation for Hypothalamic Obesity: A Surgical & Neuroimaging Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects
研究概览
简要总结
The balance between hunger and satiety is imperative for an individual's survival and overall health.). Without this balance, individuals can become morbidly obese or lack adequate nutrition for survival. Craniopharyngioma (CP) is a benign tumour that occurs at the base of the brain in children. Unfortunately, pediatric neurosurgeons sometimes inadvertently destroy a child's satiety centre during CP tumour removal surgery. This leaves the child with a post-operative complication: an insatiable appetite. This form of obesity is called "hypothalamic obesity". This study is designed to investigate Deep Brain Stimulation for hypothalamic obesity in n=6 young adults who have stabilized tumours.
详细描述
For young adults with destroyed satiety centres due to childhood CP surgery, we believe directly re-balancing the brain's control of hunger and satiety is necessary for sustained and long-term therapy. n=6 patients will be recruited in this Phase 1 DBS trial. The proposed research will hope to improve personal health among the young adults involved in this study by improving quality of life and avoiding long-term cardiovascular morbidities. Furthermore, this study will elucidate what brain regions drive excessive hunger and develop a treatment that attempts to reverse these abnormalities.
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 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with hypothalamic obesity following craniopharyngioma tumour removal
- •Treatment refractory to pharmacological interventions such as growth hormone therapy and anti-obesity medications
排除标准
- •Unable to give consent or unmanaged psychiatric condition
结局指标
主要结局
Number of Participants With Adverse Events That Are Related to surgery and Post-Operative Side Effects
时间窗: 12 months
次要结局
- Hyperphagia Questionnaire(12 months)
- SF-36 Quality of Life Questionnaire(12 months)
- Body Mass Index (BMI)(12 months)
研究者
Christopher Honey
Professor & Neurosurgeon
University of British Columbia