Analysis of Selected Biochemical Parameters in Cerebrospinal Fluid and Peripheral Blood in the Treatment of Neuropathic Pain Using Spinal Cord Stimulation (SCS) Assessment of the Mechanism of Action of SCS and the Potential of Biochemical Studies in Therapy Planning and Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Oswestry Disability Index
研究概览
简要总结
This project aims to identify key cells and molecules involved in the development and modulation of neuropathic pain treated with spinal cord stimulation (SCS). By measuring concentrations of selected inflammatory mediators and signaling molecules (e.g., IL-1β, IL-6, IL-17, IL-33, BDNF, VEGF, GABA) in the blood and cerebrospinal fluid (CSF) of patients undergoing SCS, the study seeks to better understand the mechanism of action of SCS. The findings may allow the development of predictive biomarkers, help tailor stimulation parameters, and support complementary pharmacotherapy. The project also explores differences in response to various stimulation types and the role of glial cells in SCS efficacy, with a view to improving patient outcomes through more personalized neuromodulation strategies.
详细描述
- The Aim of the Project
The aim of this project is to measure the concentrations of selected inflammatory mediators and other signalling molecules in the blood and cerebrospinal fluid (CSF) of patients undergoing spinal cord stimulation (SCS). The goal is to identify which cells and molecules are crucial in the development of neuropathic pain and its treatment via SCS. This will provide insight into the mechanisms underlying SCS and enhance our understanding of how it works.
Additionally, the correlation between the concentrations of these molecules and patients' clinical status, treatment outcomes (whether successful or not), and especially blood concentrations of certain markers, may allow for the development of simple tools for predicting the response to a particular type of stimulation, monitoring treatment effectiveness, and identifying potential complementary pharmacotherapies.
Previous research conducted by my team, which forms the basis for this project, has shown that SCS affects iron and calcium metabolism and that different types of stimulation vary in their effectiveness in reducing pain. This variation may stem from the superiority of one method over another or from patient-specific factors, which this study aims to clarify. 2. Importance of the Project
SCS has been successfully used to treat neuropathic pain for over fifty years. Despite ongoing advancements-such as new devices and stimulation techniques-the exact mechanism of SCS remains unknown. Not only is it unclear which cells mediate pain signal inhibition, but even the precise target site of stimulation is still under debate. Genomic studies on animal models have so far failed to resolve this issue.
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 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-80
- •PSPS or CRPS
- •Neuropathic pain for at least 6 months
排除标准
- •Drug/alcohol addiction
- •Malignant tumour
- •Psychiatric disorders
- •Active infection
- •Pregnancy
结局指标
主要结局
Oswestry Disability Index
时间窗: baseline and after 14 days of trial stimulation
Oswestry Disability Index before and after trial stimulation
Pain reduction
时间窗: baseline and after 14 days of trial stimulation
VAS
次要结局
- Changes in blood and CSF inflammatory markers(baseline and after 14 days of trial stimulation)
研究者
Pawel Sokal
Professor
Jan Biziel University Hospital No 2 in Bydgoszcz
