Closed-loop spinal cord stimulation for painful chemotherapy-induced peripheral neuropathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

* 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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.