Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPRESS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neuropathic Pain; Chemotherapy Induced Peripheral Neuropathy (CIPN)

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.

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Esmee Van Leeuwen, MSc; Phone Number: 088 005 8888; Email: evanleeuwen@rijnstate.nl
• Study Contact Backup: Name: Nick Koning, MD PhD

Study Locations

• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • Recruiting
    • Rijnstate Hospital
    • Contact: Esmee Van Leeuwen, MSc; Phone Number: 088 005 8888; Email: evanleeuwen@rijnstate.nl
    • Contact: Email: jkallewaard@rijnstate.nl
    • Principal Investigator: Nick J Koning, MD PhD
    • Principal Investigator: Jan Willem Kallewaard, MD PhD
  • Nieuwegein, Netherlands
    • Recruiting
    • Sint Antonius Ziekenhuis
    • Contact: Harold Nijhuis, MD; Phone Number: +3188 320 3000; Email: h.nijhuis@antoniusziekenhuis.nl
  • Roosendaal, Netherlands
    • Recruiting
    • Bravis Hospital
    • Contact: Lars Elzinga, MD; Phone Number: +3188 706 8000; Email: l.elzinga@bravis.nl
  • Tilburg, Netherlands
    • Recruiting
    • ETZ
    • Contact: Johan van de Minkelis, MD; Phone Number: +3113 221 0000; Email: jl.vandeminkelis@etz.nl
  • Zwijndrecht, Netherlands
    • Recruiting
    • ASZ
    • Contact: Hans Aukes, MD; Phone Number: +3178654 22 19; Email: h.aukes@asz.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with painful chemotherapy induced peripheral neuropathy resistent to conventional medical management. Patients are eligible for SCS implantation and are scheduled to undergo closed-loop SCS implantation.

Description

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with painful chemotherapy induced peripheral neuropathy (CIPN); Subjects diagnosed with painful CIPN and eligible for SCS implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall pain intensity	The primary effectiveness outcome measure is pain intensity measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain) at 1, 3, 6 and 12 months after SCS implantation.	The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity for the extremities (arms and/or legs)	Pain intensity for the arms and/or legs measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain).	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)	Assessment of quality of life in seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) all assessed using the PROMIS-29 questionnaire. PROMIS-29 is scored on a T-score metric with a mean of 50 and a standard deviation of 10 in the U.S. general population, with a higher score representing more symptoms.	The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
CIPN-related symptoms	Assessment of CIPN-related symptoms using the European Organization for Research and Treatment of Cancer Quality of Life-Chemotherapy-Induced Peripheral Neuropathy Questionnaire (EORTC QLQ-CIPN20). EORTC QLQ-CIPN20 contains 20 items scored on a 4-point Likert scale for sensory, motor and autonomic symptoms. Scale scores are linearly converted to a 0-100 scale, with higher scores indicating increased symptoms.	The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
Medication use	Assessment of pain medication use	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)	Assessment of the patient impression of global improvement with treatment using a 7-point rating scale, ranging from 1 to 7. Higher scores indicate a patient perspective of a worsening of the health condition.	The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
Stimulation coverage and patient stimulation awareness and satisfaction	Assessment of the percentage of stimulation coverage of the painful area, and of stimulation sensation (awareness and quality) during closed-loop spinal cord stimulator (CL-SCS) therapy	Evaluation at 1, 3, 6 and 12 months after SCS implantation
SCS stimulation pulse width	The pulse width in milliseconds of the active SCS stimulation program will be collected.	Evaluation at 1, 3, 6 and 12 months after SCS implantation.
SCS stimulation frequency	Frequency of the active SCS stimulation program measured in Hertz will be collected	Evaluation at 1, 3, 6 and 12 months after SCS implantation.
(Serious) adverse events	Assessment of treatment-related complications	Evaluation at 1, 3, 6 and 12 months after SCS implantation

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Collaborators: Saluda Medical Pty Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: December 11, 2025
• First Submitted That Met QC Criteria: December 24, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 24, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Spinal Cord Stimulation; neuropathic pain; CIPN; SCS; Closed-Loop; Chemotherapy induced peripheral neuropathy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neuralgia
• Other Study ID Numbers: 2025-2667

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No