Actively Recruiting
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-1β, 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
Eligibility Criteria
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
You will not qualify if you...
- Current drug or alcohol addiction
- Presence of malignant tumor
- Psychiatric disorders
- Active infection
- Pregnancy
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo the first surgery to implant temporary spinal cord stimulation electrodes and have blood and cerebrospinal fluid samples collected.
1 visit (in-person)
Duration - 2 to 3 weeks
Participants receive trial spinal cord stimulation with a temporary pulse generator for 2 to 3 weeks. Blood samples are collected before or on the day of the first surgery and again 2-3 weeks later. Pain and quality of life are assessed, and participants keep a medication log.
Approximately 2 visits (in-person)
Duration - 1 day
Participants who respond positively to trial stimulation undergo a second surgery for permanent pulse generator implantation with cerebrospinal fluid sample collection. Non-responders may have electrodes removed or alternative stimulation parameters tried.
1 visit (in-person)
Duration - Up to 2 to 3 weeks
Participants are monitored after permanent implantation or electrode removal with pain, disability, and neurological assessments conducted approximately 2-3 weeks after the first surgery.
1 follow-up visit (in-person)
Trial Site Locations
Total: 1 location
1
Jan Bizel University Hospital
Bydgoszcz, Poland, 85-168
Actively Recruiting
Research Team
O
Oskar Puk Mr, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
1
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