Closed-loop spinal cord stimulation for painful chemotherapy-induced peripheral neuropathy
Assessment of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy on Pain Reduction and Improvement of Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy
Rijnstate Hospital · NCT07304401
This observational project will try closed-loop spinal cord stimulation to reduce neuropathic pain in adults who developed peripheral neuropathy after chemotherapy.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Arnhem and 4 other locations) |
| Trial ID | NCT07304401 on ClinicalTrials.gov |
What this trial studies
This observational study follows adults with chemotherapy-induced peripheral neuropathy who are already scheduled to receive the Evoke closed-loop spinal cord stimulation (CL-SCS) system. The CL-SCS device delivers pulses to the dorsal columns, records evoked compound action potentials (ECAPs) and automatically adjusts stimulation in real time for each pulse. Participants must have persistent neuropathic pain (≥5/10) at least six months after chemotherapy and have failed medications and minimally invasive pain treatments. Outcomes will track pain intensity and quality-of-life measures to describe the real-world effectiveness of CL-SCS in this population across several Dutch hospitals.
Who should consider this trial
Good fit: Adults (≥18) with CIPN at least six months after chemotherapy, persistent neuropathic pain ≥5/10, deemed suitable for Evoke SCS implantation and who have not had satisfactory relief from medications or minimally invasive pain treatments are ideal candidates.
Not a fit: Patients with recent chemotherapy (<6 months), low pain scores, active contraindications to SCS, ongoing uncontrolled cancer treatment, pregnancy, or inability to undergo implantation are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, CL-SCS could provide better and more consistent pain relief and improve quality of life for people with refractory chemotherapy-induced peripheral neuropathy.
How similar studies have performed: Open-loop spinal cord stimulation has shown pain and quality-of-life benefits for some patients with painful CIPN, while closed-loop SCS is a newer approach with promising but less extensive real-world evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
* Subject is deemed a suitable candidate for SCS implantation and has been routinely scheduled to undergo an SCS implantation with the Evoke SCS System. * Subject has a minimum of leg or arm pain intensity of 5/10 on the numeric rating scale (NRS) at baseline due to CIPN. * Patients with CIPN following chemotherapy and at least 6 months post-treatment * CIPN symptoms for a minimum duration of 3 months. * Patient deemed to be in remission per discretion of treating oncologist * No existing contraindications for SCS * Subject is ≥ 18 years old. * Subject is not pregnant or nursing. * Subject is willing and capable of giving informed consent. * No satisfactory treatment effect with anti-neuropathic medication or intolerable side-effects * No satisfactory treatment effect with minimal invasive pain treatments (including ketamine or lidocaine infusion therapy) Exclusion Criteria: * Patient refusal to be included in study * Patients unwilling or mentally incapable to complete the study questionnaires * Other causes of neuropathy (for example diabetic- or small fiber neuropathy) * Previous treatment with SCS for CIPN * Presence of another pain syndrome unrelated to CIPN * History of lower limb amputation or ulceration * Body mass index (BMI) ≥ 40 * Severe psychiatric or neurological disorders * Any other contra indication for locoregional anaesthesia
Where this trial is running
Arnhem and 4 other locations
- Rijnstate Hospital — Arnhem, Netherlands (RECRUITING)
- Sint Antonius Ziekenhuis — Nieuwegein, Netherlands (RECRUITING)
- Bravis Hospital — Roosendaal, Netherlands (RECRUITING)
- ETZ — Tilburg, Netherlands (RECRUITING)
- ASZ — Zwijndrecht, Netherlands (RECRUITING)
Study contacts
- Study coordinator: Esmee Van Leeuwen, MSc
- Email: evanleeuwen@rijnstate.nl
- Phone: 088 005 8888
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.
Conditions: Chemotherapy Induced Peripheral Neuropathy, Neuropathic Pain, CIPN, Chemotherapy induced peripheral neuropathy, Spinal Cord Stimulation, SCS, Closed-Loop, neuropathic pain