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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRijnstate Hospital

About this trial

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

Qualifiers

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.

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

20 Participants
are grouped into 1 trial group

Sponsors and collaborators

Rijnstate Hospital

Lead sponsor

Saluda Medical Pty Ltd

Collaborator