Immune and signaling markers in blood and spinal fluid during spinal cord stimulation for neuropathic pain
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
This project tests whether measuring immune and signaling molecules in blood and cerebrospinal fluid can help explain and predict how spinal cord stimulation works for adults with chronic neuropathic pain.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Jan Biziel University Hospital No 2 in Bydgoszcz Academic / other |
| Locations | 1 site (Bydgoszcz) |
| Trial ID | NCT07153211 on ClinicalTrials.gov |
What this trial studies
Participants undergoing spinal cord stimulation will have blood and cerebrospinal fluid sampled to measure selected inflammatory mediators and signaling molecules such as IL-1β, IL-6, IL-17, IL-33, BDNF, VEGF, and GABA. Concentrations of these markers will be correlated with clinical status, pain outcomes, and different stimulation types to identify patterns linked to treatment response. The study also examines the potential role of glial cell–related signals and differences between stimulation modalities. Findings aim to support biomarker development, optimization of stimulation parameters, and complementary pharmacotherapy strategies.
Who should consider this trial
Good fit: Adults aged 18–80 with chronic neuropathic pain due to persistent spinal pain syndrome (PSPS) or complex regional pain syndrome (CRPS) lasting at least six months who are undergoing or being considered for SCS are the intended participants.
Not a fit: Patients with active infection, malignant tumors, substance dependence, serious psychiatric disorders, or who are pregnant are excluded and unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help doctors predict which patients and which stimulation settings are most likely to reduce pain and allow more personalized neuromodulation.
How similar studies have performed: Prior smaller studies report that SCS can alter inflammatory mediators and glial activity, but robust, clinically useful predictive biomarkers have not yet been consistently validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18-80 * PSPS or CRPS * Neuropathic pain for at least 6 months Exclusion Criteria: * Drug/alcohol addiction * Malignant tumour * Psychiatric disorders * Active infection * Pregnancy
Where this trial is running
Bydgoszcz
- Jan Bizel University Hospital — Bydgoszcz, Poland (Recruiting)
Study contacts
- Study coordinator: Oskar Puk Mr, MD
- Email: oskar.puk@biziel.pl
- Phone: +48 52 365 5205
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.