Actively Recruiting
Assessment of Effectiveness of Closed-loop Spinal Cord Stimulation Therapy on Pain Reduction and Quality of Life in Patients With Chemotherapy Induced Peripheral Neuropathy
Led by Rijnstate Hospital · Updated on 2025-12-26
20
Participants Needed
5
Research Sites
N/A
Total Duration
On this page
Sponsors
R
Rijnstate Hospital
Lead Sponsor
S
Saluda Medical Pty Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness of closed-loop spinal cord stimulation (CL-SCS) therapy in patients suffering from painful chemotherapy induced peripheral neuropathy (CIPN). CIPN affects up to 40% of chemotherapy patients and causes significant pain. Traditional treatments include medications and other interventions, but evidence for their success is limited. CL-SCS is an advanced method that stimulates nerves in the spinal cord and adjusts stimulation automatically in real time to manage pain. The study involves patients diagnosed with painful CIPN who are scheduled for CL-SCS implantation using the Evoke SCS System. This system sends electrical pulses to the spinal cord, measures nerve responses, and adapts stimulation accordingly. The research observes patients receiving this treatment without a comparison group, tracking effects over time. Participants will be followed for up to 12 months after implantation. Researchers will assess changes in overall pain intensity, pain in arms or legs, CIPN symptoms, medication use, quality of life, and patient satisfaction at 1, 3, 6, and 12 months. Safety will be monitored by recording any serious adverse events during this period. The study collects detailed patient reports and device data to understand CL-SCS therapy's impact on pain and quality of life in CIPN patients.
CONDITIONS
Brief Title
Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subject is deemed suitable for spinal cord stimulation implantation and scheduled for the Evoke SCS System implantation
- Minimum leg or arm pain intensity of 5 out of 10 on numeric rating scale due to CIPN
- CIPN symptoms present for at least 3 months
- At least 6 months post-chemotherapy treatment
- Patient deemed to be in remission by treating oncologist
- No existing contraindications for spinal cord stimulation
- Age 18 years or older
- Not pregnant or nursing
- Willing and able to give informed consent
- No satisfactory treatment effect with anti-neuropathic medication or intolerable side effects
- No satisfactory treatment effect with minimally invasive pain treatments including ketamine or lidocaine infusion therapy
You will not qualify if you...
- Patient refusal to participate in the study
- Unable or unwilling to complete study questionnaires
- Neuropathy caused by other conditions such as diabetic or small fiber neuropathy
- Previous spinal cord stimulation treatment for CIPN
- Presence of another unrelated pain syndrome
- History of lower limb amputation or ulceration
- Body mass index (BMI) of 40 or higher
- Severe psychiatric or neurological disorders
- Any contraindication for locoregional anesthesia
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of implantation
Participants undergo implantation of the closed-loop spinal cord stimulation (CL-SCS) system to manage pain from chemotherapy induced peripheral neuropathy.
1 visit (in-person)
Duration - 12 months
Participants are monitored for pain intensity, quality of life, and device performance at multiple time points after implantation.
Visits at 1, 3, 6, and 12 months after implantation
Trial Site Locations
Total: 5 locations
1
Rijnstate Hospital
Arnhem, Netherlands, 6815 AD
Actively Recruiting
2
Sint Antonius Ziekenhuis
Nieuwegein, Netherlands
Actively Recruiting
3
Bravis Hospital
Roosendaal, Netherlands
Actively Recruiting
4
ETZ
Tilburg, Netherlands
Actively Recruiting
5
ASZ
Zwijndrecht, Netherlands
Actively Recruiting
Research Team
E
Esmee Van Leeuwen, MSc
N
Nick Koning, MD PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here