Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation (EVOKE)
The Ainsworth Institute of Pain Management has been selected to participate in a FDA IDE Phase III clinical trial that is evaluating the safety and effectiveness of the Evoke™ Spinal Cord Stimulation (SCS) System with feedback, for the treatment of chronic pain of the lower back and legs.
Spinal cord stimulation is a well-established treatment for chronic pain, with much advancement over the last 40 years. SCS devices currently on the market rely on patients to manually adjust stimulation dose to treat their pain. Clinical data have shown that about half of patients achieve a 50 percent or greater reduction in pain with currently available SCS devices.
In contrast, the Evoke System is the first closed-loop SCS system being evaluated in clinical trials that is designed to measure the body’s response to stimulation and automatically adjust the stimulation dose to control pain. Evoke is an intelligent system designed to communicate and understand when and how much to stimulate the spinal cord to treat pain.
The Evoke Clinical Study is a prospective, multicenter, randomized double-blinded study. The study will evaluate the safety and effectiveness of the Evoke SCS System with feedback, for the treatment of chronic pain of the lower back and legs.
To qualify for the Evoke Study, candidates must have struggled with both leg and back pain for at least six months and have not had lasting success with other pain treatments. Many study candidates may have had back surgery, including disc surgery or spinal fusion procedures, but still experience pain even after the surgery has fixed the anatomical problem. Participants must be willing to undergo a surgical procedure and come in for follow-up visits.
The study is being sponsored by Saluda Medical.
DRG stimulation is one of THE most impressive advancements ever seen in the field of pain management. According to the United States FDA clinical trial, patients with CRPS who were treated with the DRG stimulator reported, on average, 81.4% to 86% reduction in pain. In addition, sensitivity, swelling and skin color – all have been have been shown to improve with this amazing therapy.
Spinal Cord Stimulation (SCS)
SCS is an innovative procedure that has yielded results for patients with pain in their back or limbs who have not found relief from any other treatments. In SCS, an electrical pulse is delivered directly to the spine, blocking certain neuron fibers’ access to the brain and consequently the brain’s ability to sense the previously perceived pain. Patients who qualify for this procedure report up to a 70% reduction in pain.
Can I Participate in this Study?
Details of the Study
A maximum of 134 adult subjects with moderate to severe chronic, intractable, low back and/or leg pain will undergo a trial of open loop SCS(traditional) or closed loop SCS (experimental). Only subjects who report 50% or greater reduction in overall pain intensity will go on to receive an implanted device. Patients will be followed for up to 1-year.
Study Enrollment Form
Official Protocol Name: EVOKE: A Prospective, Multicenter, Randomized Double-blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System With Feedback to Treat Patients With Chronic Pain of the Trunk and/or Limbs.
Get Answers to Your Questions at the Ainsworth Institute
The key to finding the proper treatment for any type of pain is getting a proper diagnosis. Not all types of pain respond to the same treatments and the window for improvement can be limited. The experts at Ainsworth Institute offer the most advanced pain management treatments available today, including advanced clinical trials that aren’t yet available to the general public. Call us today for an appointment so we can get you started on your road to recovery.