No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
20 (estimated)
Sponsor
Rijnstate Hospital · Other
Who this trial is looking for
Think this trial could be right for you?
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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.
Trial Locations
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Status
Eligibility Criteria
* 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 follow…
* 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
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