Immune and signaling markers in blood and spinal fluid during spinal cord stimulation for neuropathic pain
Official title: 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
Run by Jan Biziel University Hospital No 2 in Bydgoszcz · NCT07153211 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | Jan Biziel University Hospital No 2 in Bydgoszcz Academic / other |
| Locations | 1 site (Bydgoszcz) |
| Status | Recruiting |
| Started | November 1, 2022 |
| Main results expected | September 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | September 3, 2025 |
| Trial ID | NCT07153211 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Virtual Reality-Based Hypnotherapy to Help Pain, Sleep, and Mood in Spinal Cord Injury
Adults with spinal cord injury will try adding short VR-based hypnotherapy sessions to their standard physiotherapy to see if it reduces pain and improves sleep and mood.
-
Spinal cord stimulation plus rehabilitation for severe chronic neuropathic leg pain
This project will try combining spinal cord stimulation with a multidisciplinary rehabilitation program to reduce severe nerve pain and improve physical function in adults with chronic neuropathic leg pain.
-
Progressive resistance exercise to reduce pain in people with multiple sclerosis
This program will test whether 12 weeks of progressive resistance exercise can reduce chronic neuropathic pain in adults with multiple sclerosis.
-
Refining multiple AI strategies for automatic pain assessment (RUGGI)
This project tests whether AI models using wearable sensors, facial video/thermography, and physiological signals can detect and estimate pain in adults with chronic or cancer-related pain.
-
Assessing nerve activation in spinal cord stimulation for chronic pain
This study looks at how different settings on a spinal cord stimulator affect nerve activity and sensations in patients with chronic pain to help improve pain management.
-
Assessing psychological factors in patients receiving spinal cord stimulation for chronic pain
This study looks at how anxiety and depression affect pain relief and satisfaction in patients getting spinal cord stimulation for chronic pain.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.