Phase 1 Study of Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome
试验速览
- 阶段
- 1 期
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- resting energy expenditure
研究概览
简要总结
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment.
详细描述
The purpose of this study is to investigate the safety and efficacy of deep brain stimulation in obese patients with Prader Willi syndrome refractory to conventional treatment. Patients will be implanted with hypothalamic DBS electrodes. Calorimetric and anthropometric measures, body mass index, side effects, neuropsychiatric evaluations will be carried out at 6 months for measuring primary and secondary outcome. Side effects will be monitored at 1, 3, 6 and 12 months following surgery.
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
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •15 years or older
- •Parents able to give informed consent
- •Diagnosis of Prader-Willi syndrome confirmed by genetic analysis
- •Refractoriness to medical treatment, defined as a weight loss lower than 10% of the body weight with nutritional, pharmacological or surgical interventions
- •Severe or morbid obesity
- •No contra-indications to the surgical procedure
排除标准
- •Cardiovascular disease that might significantly increase the surgical risk
- •Brain lesions detected clinically or during MRI
- •Use of cardiac pacemakers/ defibrillators
- •Clinical conditions that may require the use of MRI in the post-operative period
- •Patients undergoing chemotherapy or immunosuppressive treatments
- •Patients unable to return to the hospital at the required intervals
- •Previous neurosurgical treatments that may increase the risk of DBS surgery
- •Active medical conditions that may require in-hospital treatment in the nearby future
- •Previous diagnosis of epilepsy or status epilepticus
- •Chronic infection
- •Plan to use diathermy
- •Metallic implants that might preclude MRI imaging of the brain
- •Active participation in other experimental studies
研究组 & 干预措施
Deep Brain Stimulation
Patients with Prader-Willi syndrome to receive DBS.
干预措施: Deep Brain Stimulation (Device)
结局指标
主要结局
resting energy expenditure
时间窗: 6 months
Body mass index
时间窗: 6 months
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
时间窗: 6 months
waist circumference; mid-upper arm circumference
时间窗: 6 months
次要结局
- daily food ingestion diary listing(6 months)
- Child Yale-Brown Obsessive Compulsive Scale(6 months)
- Feeding Behaviour Questionnaire(6 months)
- Child Behaviour Checklist(6 months)