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临床试验/NCT07153211
NCT07153211招募中不适用

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

Pawel Sokal2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月1日最近更新:

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

  1. 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

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

发起方
Pawel Sokal
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Pawel Sokal

Professor

Jan Biziel University Hospital No 2 in Bydgoszcz

研究点 (2)

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