An observational study in Chemotherapy Induced Peripheral Neuropathy (CIPN) and Neuropathic Pain, sponsored by Rijnstate Hospital. Recruiting at 5 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-26.
Sponsored by Rijnstate Hospital · Observational
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.
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.
1,100 studies on the registry are indexed under Neuralgia; 241 are open to participants now.
This study's planned enrollment of 20 is below the median of 102 across 231 observational studies indexed under Neuralgia.
Browse Neuralgia studies →Rijnstate Hospital is the lead sponsor of 130 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects diagnosed with painful CIPN and eligible for SCS implantation
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.
Time frame: The difference between baseline and the evaluation at 1, 3, 6 and 12 months after SCS implantation.
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).
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)
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.
Time frame: 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.
Time frame: The change between baseline and the evaluation 1, 3, 6 and 12 months after SCS implantation.
Medication use
Assessment of pain 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)
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.
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
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
Time frame: 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.
Time frame: 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
Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation.
(Serious) adverse events
Assessment of treatment-related complications
Time frame: Evaluation at 1, 3, 6 and 12 months after SCS implantation
Plan to share: No
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