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ClinicalTrials.gov ID

NCT07304401

Lead Sponsor

Rijnstate HospitalOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

20Estimated

Last Update Posted

Dec 26, 2025Actual

Start Date

Dec 1, 2025Estimated

Primary Completion Date

Dec 1, 2028Estimated

Completion Date

Dec 1, 2028Estimated

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

Brief Summary

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.

• Chemotherapy Induced Peripheral Neuropathy (CIPN)
• Neuropathic Pain

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

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

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Rijnstate HospitalOTHER

Collaborators

Saluda Medical Pty LtdINDUSTRY

jl.vandeminkelis@etz.nl+3113 221 0000

h.aukes@asz.nl+3178654 22 19