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

NCT07153211 | Recruiting

• 1 other identifier: KB345/2022
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neuropathic Pain; Chronic Pain; Spinal Cord Stimulation (SCS)

Keywords

spinal cord stimulation; neuropathic pain; immunomodulatory effects of scs

Outcome Measures

Primary Outcomes (2)

• Oswestry Disability Index

  Oswestry Disability Index before and after trial stimulation

  baseline and after 14 days of trial stimulation

• Pain reduction

  VAS

  baseline and after 14 days of trial stimulation

Secondary Outcomes (1)

• Changes in blood and CSF inflammatory markers

  baseline and after 14 days of trial stimulation

Study Arms (1)

Patients with SCS - tonic stimulation

EXPERIMENTAL

We plan to include 30-50 patients with PSPS or CRPS undergoing SCS implantation. Blood will be collected before surgery and 2-3 weeks after; CSF during both procedures. Pain (VAS), disability (ODI), neurological status, muscle tone, and analgesic intake will be assessed. Temporary stimulation will last 2-3 weeks before IPG implantation or electrode removal. Samples will be processed and analyzed via ELISA in our Biochemistry Department using established protocols.

Diagnostic Test: Immunological Factors

Interventions

Immunological Factors DIAGNOSTIC_TEST

Assessment of interleukins and other molecues in CSF and blood of patients with SCS.

Patients with SCS - tonic stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80
• PSPS or CRPS
• Neuropathic pain for at least 6 months

You may not qualify if:

• Drug/alcohol addiction
• Malignant tumour
• Psychiatric disorders
• Active infection
• Pregnancy

Sponsors & Collaborators

• Pawel Sokal: lead
• Department of Neurosurgery Collegium Medicum Nicolaus Copernicus University: collaborator
• Nicolaus Copernicus University in Toruń, Collegium Medicum in Bydgoszcz: collaborator

Study Sites (1)

Jan Bizel University Hospital

Bydgoszcz, 85-168, Poland

RECRUITING

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Oskar Puk Mr, MD

CONTACT

+48 52 365 5205; oskar.puk@biziel.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Model Details: Cohort study

Study Record Dates

• First Submitted: August 10, 2025
• First Posted: September 3, 2025
• Study Start: November 1, 2022
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)