Spinal Cord Stimulation for Chronic Pain
(Neural Panel Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this study is to evaluate the clinical utility of neurophysiological measurements of ECAP-controlled closed-loop SCS (i.e., neural panel metrics) to guide treatment of chronic pain of the trunk and/or limbs.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
Is spinal cord stimulation safe for humans?
Spinal cord stimulation (SCS), including the Evoke system, is generally considered safe for treating chronic pain, with long-term safety data supporting its use. However, there are risks, such as potential complications from electrode removal and the rare possibility of spinal cord injury during implantation.12345
How is the Evoke Spinal Cord Stimulation (SCS) System treatment different from other treatments for chronic pain?
The Evoke Spinal Cord Stimulation (SCS) System is unique because it uses advanced technology to provide more precise and adjustable pain relief through programmable stimulation parameters and dual electrode arrays, which can be tailored to individual patient needs, unlike traditional SCS systems.678910
What data supports the effectiveness of the Evoke Spinal Cord Stimulation (SCS) System treatment for chronic pain?
The Evoke Spinal Cord Stimulation (SCS) System is effective for chronic pain as it uses a unique feedback mechanism to adjust stimulation levels, which is not available in other devices. Spinal cord stimulation, in general, is a well-established treatment for chronic pain, with advancements in technology improving its effectiveness for various pain conditions.147910
Are You a Good Fit for This Trial?
This trial is for adults with chronic pain in the back and/or limbs, including those with failed back surgery syndrome. Participants must have significant pain (≥6 cm on a pain scale), be planning to try the Evoke Spinal Cord Stimulation System, speak English, and can consent to study procedures. Pregnant individuals or those under 18 cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive ECAP-controlled closed-loop spinal cord stimulation to manage chronic pain
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Evoke Spinal Cord Stimulation (SCS) System
Evoke Spinal Cord Stimulation (SCS) System is already approved in United States for the following indications:
- Chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain, and leg pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Saluda Medical Pty Ltd
Lead Sponsor