Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in sensory parameters
研究概览
简要总结
The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST).
Patients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.
After the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.
The investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •minimum age 18
- •able to understand participant information and cooperate at the neurological examination
- •uncomplicated treatment with spinal cord stimulation for at least 3 months
- •pain in only one extremity
- •treatment effect in only one extremity
排除标准
- 未提供
研究组 & 干预措施
Active SCS
干预措施: Active SCS (Device)
Inactive SCS
干预措施: Deactivated (Device)
结局指标
主要结局
Change in sensory parameters
时间窗: 24 hours
次要结局
未报告次要终点