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

Recruitingn/aAges 18 Years - anyAllRijnstate Hospital
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
* 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 โ‰ฅ 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) โ‰ฅ 40 * Severe psychiatric or neurological disorders * Any other contra indication for locoregional anaesthesia
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What it tests

  • Not listed
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Where

5 sites
Rijnstate Hospital
Arnhem, Netherlands
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Bravis Hospital
Roosendaal, Netherlands
ETZ
Tilburg, Netherlands
ASZ
Zwijndrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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