NCT07304401 Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy
| NCT ID | NCT07304401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rijnstate Hospital |
| Condition | Chemotherapy Induced Peripheral Neuropathy (CIPN) |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-12-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
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 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07304401 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy Induced Peripheral Neuropathy (CIPN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07304401 currently recruiting?
Yes, NCT07304401 is actively recruiting participants. Contact the research team at evanleeuwen@rijnstate.nl for enrollment information.
Where is the NCT07304401 trial being conducted?
This trial is being conducted at Arnhem, Netherlands, Nieuwegein, Netherlands, Roosendaal, Netherlands, Tilburg, Netherlands and 1 additional location.
Who is sponsoring the NCT07304401 clinical trial?
NCT07304401 is sponsored by Rijnstate Hospital. The trial plans to enroll 20 participants.