Actively Recruiting
Evaluation of Effectiveness of Closed-loop Spinal Cord Stimulation (CL-SCS) Therapy for Treatment of Chemotherapy Induced Peripheral Neuropathy
Led by Rijnstate Hospital · Updated on 2025-12-26
20
Participants Needed
5
Research Sites
156 weeks
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
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.
CONDITIONS
Official 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 a suitable candidate for SCS implantation and has been scheduled to undergo an SCS implantation with the Evoke SCS System.
- Subject has a minimum leg or arm pain intensity of 5 out of 10 on the numeric rating scale at baseline due to CIPN.
- Patients have CIPN following chemotherapy and are at least 6 months post-treatment.
- CIPN symptoms must have lasted for a minimum of 3 months.
- Patient is considered to be in remission as determined by the treating oncologist.
- No existing contraindications for spinal cord stimulation.
- Subject is 18 years or older.
- Subject is not pregnant or nursing.
- Subject is 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 refuses to be included in the study.
- Patients are unwilling or mentally unable to complete the study questionnaires.
- Presence of other causes of neuropathy such as diabetic or small fiber neuropathy.
- Previous treatment with spinal cord stimulation for CIPN.
- Presence of another pain syndrome unrelated to CIPN.
- History of lower limb amputation or ulceration.
- Body mass index (BMI) of 40 or greater.
- Severe psychiatric or neurological disorders.
- Any other contraindication for locoregional anesthesia.
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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
CONTACT
N
Nick Koning, MD PhD
CONTACT
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
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