Chemotherapy Induced Peripheral Neuropathy (CIPN)CIPRESSNCT07304401
Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy
An observational study of Chemotherapy Induced Peripheral Neuropathy (CIPN) and Neuropathic Pain, run by Rijnstate Hospital at 5 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chemotherapy Induced Peripheral Neuropathy (CIPN), Neuropathic Pain
- How many people
- 20 participants
- Where
- 5 sitesNetherlands
- Study dates
- 1 Dec 2025to 1 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
None listed.
Who cannot join
- 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
Show all 9Show fewer
- Body mass index (BMI) ≥ 40
- Severe psychiatric or neurological disorders
- Any other contra indication for locoregional anaesthesia
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nick Koning, MD PhD contact
5 sites in 1 country
Netherlands5 sites, 5 recruiting
- Recruiting
Rijnstate Hospital
Arnhem, 6815 AD
Esmee Van Leeuwen, MSc, 088 005 8888, evanleeuwen@rijnstate.nl
jkallewaard@rijnstate.nl
- Recruiting
Sint Antonius Ziekenhuis
Nieuwegein
Harold Nijhuis, MD, +3188 320 3000, h.nijhuis@antoniusziekenhuis.nl
- Recruiting
Bravis Hospital
Roosendaal
Lars Elzinga, MD, +3188 706 8000, l.elzinga@bravis.nl
- Recruiting
ETZ
Tilburg
Johan van de Minkelis, MD, +3113 221 0000, jl.vandeminkelis@etz.nl
- Recruiting
ASZ
Zwijndrecht
Hans Aukes, MD, +3178654 22 19, h.aukes@asz.nl
About this study
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
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.
Read the 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.
- Keywords
- CIPN, Chemotherapy induced peripheral neuropathy, Spinal Cord Stimulation, SCS, Closed-Loop, neuropathic pain
- Medical subject headings
- Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with painful chemotherapy induced peripheral neuropathy (CIPN) | Subjects diagnosed with painful CIPN and eligible for SCS implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Pain intensity for the arms and/or legs measured with the Numeric Rating Scale (NRS; 0 no pain, 10 worst imaginable pain).
Measured: 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.
Measured: 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.
Measured: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
Medication use
Assessment of pain medication use
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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
Measured: Evaluation at 1, 3, 6 and 12 months after SCS implantation.
(Serious) adverse events
Assessment of treatment-related complications
Measured: Evaluation at 1, 3, 6 and 12 months after SCS implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2025
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chemotherapy Induced Peripheral Neuropathy (CIPN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Saluda Medical Pty Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07304401
- Sponsor's protocol ID
- 2025-2667
- Acronym
- CIPRESS
- Status last verified
- Dec 2025
- First submitted
- 11 Dec 2025
- Last updated
- 26 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07304401
- Acronym / sponsor ID
- CIPRESS / 2025-2667
- Keywords
- CIPN, Chemotherapy induced peripheral neuropathy, Spinal Cord Stimulation, SCS, Closed-Loop, neuropathic pain
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Saluda Medical Pty Ltd
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 26 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with painful chemotherapy induced peripheral neuropathy (CIPN) | – | –Subjects diagnosed with painful CIPN and eligible for SCS implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nick Koning, MD PhD contact
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chemotherapy Induced Peripheral Neuropathy (CIPN) and Neuropathic Pain, run by Rijnstate Hospital at 5 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esmee Van Leeuwen, MSc (088 005 8888, evanleeuwen@rijnstate.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall pain intensity (time frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2025.