Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Chemotherapy Induced Peripheral Neuropathy (CIPN), Neuropathic Pain. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The goal of this observational study is to learn about the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy for treatment of painful chemotherapy induced peripheral neuropathy. The closed-loop SCS (CL-SCS) system stimulates the nerves in the spinal cord, measures their responses and automatically adjust the stimulation level accordingly in real time for each delivered pulse.
Detailed description
Chemotherapy induced peripheral neuropathy (CIPN) is a serious condition that is diagnosed in up to 40% of patients who require chemotherapy. Conventional treatments for painful CIPN include both pharmacological and non-pharmacological interventions, although the underlying evidence is scarce. Spinal cord stimulation is an established treatment for pain associated with painful peripheral neuropathies. Several studies demonstrate pain relief by open-loop spinal cord stimulation (SCS) in patients with painful CIPN, with a positive effect of SCS on pain and quality of life. In the Netherlands, CIPN is an accepted indication for SCS treatment and thus SCS is a regular treatment for patients with painful and refractory CIPN. The closed-loop SCS (CL-SCS) system stimulates the dorsal column in the spinal cord, measures the response through evoked compound action potentials (ECAPs), and automatically adjust the stimulation level accordingly in real time for each delivered pulse.
The current study aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients with CIPN.
Primary outcome measures
- Overall pain intensity [Time frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.]
Secondary outcome measures (9)
- Pain intensity for the extremities (arms and/or legs) [Time frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.]
- 9-Item Patient-Reported Outcomes Measurement Information System (PROMIS-29) [Time frame: The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.]
- CIPN-related symptoms [Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.]
- Medication use [Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after treatment with closed-loop SCS]
- Patient Global Impression of Change (PGIC) [Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.]
- Stimulation coverage and patient stimulation awareness and satisfaction [Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation]
- SCS stimulation pulse width [Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.]
- SCS stimulation frequency [Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.]
- (Serious) adverse events [Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Netherlands · 5 centers
- Rijnstate Hospital — Arnhem
- Sint Antonius Ziekenhuis — Nieuwegein
- Bravis Hospital — Roosendaal
- ETZ — Tilburg
- ASZ — Zwijndrecht
Identifiers
NCT: NCT07304401 · 2025-2667