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

NCT07304401 | Recruiting

• 1 other identifier: 2025-2667
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Chemotherapy Induced Peripheral Neuropathy (CIPN); Neuropathic Pain

Keywords

CIPN; Chemotherapy induced peripheral neuropathy; Spinal Cord Stimulation; SCS; Closed-Loop; neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pain intensity for the extremities (arms and/or legs)

  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)

  The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

• CIPN-related symptoms

  The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

• 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)

  The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

Study Arms (1)

Patients with painful chemotherapy induced peripheral neuropathy (CIPN)

Subjects diagnosed with painful CIPN and eligible for SCS implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Rijnstate Hospital: lead
• Saluda Medical Pty Ltd: collaborator

Study Sites (5)

Rijnstate Hospital

Arnhem, 6815 AD, Netherlands

RECRUITING

Sint Antonius Ziekenhuis

Nieuwegein, Netherlands

RECRUITING

Bravis Hospital

Roosendaal, Netherlands

RECRUITING

ETZ

Tilburg, Netherlands

RECRUITING

ASZ

Zwijndrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Esmee Van Leeuwen, MSc

CONTACT

088 005 8888; evanleeuwen@rijnstate.nl

Nick Koning, MD PhD

CONTACT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (5)