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

December 24, 2025 updated by: Rijnstate Hospital

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Nick Koning, MD PhD

Study Locations

  • Netherlands
      • Arnhem, Netherlands, 6815 AD
        • Recruiting
        • Rijnstate Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nick J Koning, MD PhD
        • Principal Investigator:
          • Jan Willem Kallewaard, MD PhD
      • Nieuwegein, Netherlands
      • Roosendaal, Netherlands
        • Recruiting
        • Bravis Hospital
        • Contact:
      • Tilburg, Netherlands
      • Zwijndrecht, Netherlands
        • Recruiting
        • ASZ
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall pain intensity
Time Frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
Time Frame: The difference between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
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
Time Frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.

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
Time Frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after treatment with closed-loop SCS
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)
Time Frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
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
Time Frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation
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
Time Frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.
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
Time Frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.
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
Time Frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation
Assessment of treatment-related complications
Evaluation at 1, 3, 6 and 12 months after SCS implantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rijnstate Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Saluda Medical Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 26, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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