Effect of BurstDR and Tonic Spinal Cord Stimulation (SCS) on Glucose Metabolism in Patients With Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- First and second phase of insulin secretion
研究概览
简要总结
This trial investigates the effect of BurstDR and tonic spinal cord stimulation (SCS) on glucose metabolism and heart rate variability in patients with neuropathic pain.
详细描述
This study investigates the effect of spinal cord stimulation (BurstDR stimulation versus tonic stimulation versus no stimulation) on glucose metabolism, insulin secretion and heart rate variability in patients with neuropathic pain. To assess insulin secretion, hyperglycaemic clamps are performed in 10 patients. Three different stimulation conditions (BurstDR, tonic and no stimulation) are tested in 10 hyperglycaemic clamps each. A total of 30 clamps are carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •implanted BurstDR spinal cord stimulating system
- •body mass index 18-25 kg/m2
排除标准
- •neurological and psychatric diseases
- •decompensated diabetes mellitus
- •hemoglobin < 13 g/dl
- •thrombocytopenia
结局指标
主要结局
First and second phase of insulin secretion
时间窗: Insulinsecretion during clamp (2 hours)
Modulation of insulin secretion by spinal cord stimulation
次要结局
- Root Mean Square of Successive Differences (RMSSD)(Heart rate variablity during stimulation (10 minutes))