Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Central working mechanism
研究概览
简要总结
Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.
详细描述
Detect and prove the central effects of PRF and show the objective working mechanism.
PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism.
The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- 否
入选标准
- •Radicular pain in lumbar region more than 6 weeks, neuropathic
排除标准
- •Coagulopathy
- •Implanted PM or SCS device
- •Pregnancy
- •Unwilling to undergo MRI
- •Psychiatric disorders
研究组 & 干预措施
PRF-fMRI
干预措施: Pulsed Radiofrequency (Device)
结局指标
主要结局
Central working mechanism
时间窗: 6 weeks
fMRI-BOLD
次要结局
- Central working mechanism(2 times in 6 weeks)
研究者
Veerle Van Mossevelde
Principal Investigator
Universitair Ziekenhuis Brussel