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Phase Not Applicable
Age: 18Years - 80Years
All Genders
ID07153211

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

Led by Pawel Sokal · Updated on 2025-09-03

30

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

Sponsors

P

Pawel Sokal

Lead Sponsor

D

Department of Neurosurgery Collegium Medicum Nicolaus Copernicus University

Collaborating Sponsor

AI-Summary

What this Trial Is About

This research aims to understand the key cells and molecules involved in neuropathic pain treated with spinal cord stimulation SCS. It focuses on measuring inflammatory mediators and signaling molecules like IL-1, IL-6, IL-17, IL-33, BDNF, VEGF, and GABA in the blood and cerebrospinal fluid CSF of patients undergoing SCS. The study seeks to clarify how SCS works, explore differences in responses to stimulation types, and improve personalized neuromodulation strategies for neuropathic pain conditions such as post-surgical pain syndrome and complex regional pain syndrome. Patients will undergo SCS, where electrodes are placed on the spinal cord dura mater followed by trial stimulation lasting 2-3 weeks. If effective, a permanent implantable pulse generator IPG is implanted. Blood samples are collected before surgery and 2-3 weeks after, while CSF samples are taken during both the first and second procedures. Patients may be grouped based on stimulation parameters such as tonic or burst stimulation, with some possibly in a sham group. The collected samples will be analyzed for inflammatory markers using ELISA techniques. Throughout the study, participants will have their pain levels assessed using the Visual Analogue Scale VAS and quality of life measured by the Oswestry Disability Index ODI before and after trial stimulation. Neurological exams and medication logs will also be maintained. Researchers will monitor changes in inflammatory markers and clinical outcomes to evaluate the effects of SCS. The study includes ongoing safety monitoring and personalized adjustment of stimulation parameters after sample collection, with total participation spanning the trial stimulation period and follow-up assessments.

CONDITIONS

Brief Title

Analysis of Selected Biochemical Parameters in Cerebrospinal Fluid and Peripheral Blood in the Treatment of Neuropathic Pain Using Spinal Cord Stimulation (SCS)

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 80 years
  • Diagnosis of post-surgical pain syndrome (PSPS) or complex regional pain syndrome (CRPS)
  • Neuropathic pain lasting at least 6 months
Not Eligible

You will not qualify if you...

  • Current drug or alcohol addiction
  • Presence of malignant tumor
  • Psychiatric disorders
  • Active infection
  • Pregnancy

Research Team

O

Oskar Puk Mr, MD

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