#5 Closed-Loop Spinal Cord Stimulation

Overview

Every morning you get out of bed with searing pain in your leg. And though you were in bed, you never really slept. The pain keeps you up at night and minimizes your function during the day. You were prescribed opioids for the pain but you’re hesitant to take them. You’re not sure about your next treatment move, but you know relief from the pain can wait no longer. Your doctor recommends spinal cord stimulation.

Spinal cord stimulation (SCS) is a therapy through which pain relief is provided via electrical stimulus to the nerves along the spinal column. Through this stimulation, dysfunctional or hyperactive nerve activity is modified to minimize the sensation of pain. Emanating from an implanted spinal cord stimulator, these impulses provide relief by not only reducing the amount of pain signals reaching the brain, but also restoring the body’s normal pain-inhibition pathways that may have been lost due to overuse.

The FDA first approved SCS in 1989 to relieve chronic pain from nerve damage in the trunk, arms or legs. Today, the therapy accounts for about 70% of all neuromodulation treatments and some 50,000 patients worldwide undergo stimulator implants each year. And though popular and effective, traditional spinal cord stimulation has its share of flaws.

When implanted with a stimulator, each patient is prescribed a fixed-output dose of stimulation. A consistent dose is delivered to the nerves, with no regard for the individual’s activity at the time of stimulus. Should the amount be too much or too little, it must be adjusted manually. With fixed-output spinal cord stimulation, nearly 25% of patients have experienced unsatisfactory outcomes and subtherapeutic electrical doses due to overstimulation events.

With the innovation of closed-loop spinal cord stimulation, overstimulation and subsequent decrease in pain relief may become a thing of the past. New to the pain management field, this closed-loop SCS system utilizes a stimulator able to real-time communicate with the spinal cord neurons. The device is the first to measure the cord’s response to stimulation via evoked compound action potentials (ECAPs), and adjust on every pulse to maintain activation with the patient’s therapeutic window. No matter what the patient’s activity (sitting, standing, etc.) the new system ensures a level of stimulation for optimal pain relief.

At the three month point in the pivotal U.S. study of the device, results suggested astounding levels of pain relief – 82% of closed-loop subjects achieved greater than or equal to 50% pain relief, and 58% were high responders with greater than or equal to 80% reduction in back and leg pain. The system received its CE mark in September 2019 and is actively pursuing FDA approval. With this new technology, patients are getting measurable pain relief, sleeping better, and taking less medication. Pending approval, closed-loop stimulation could be saving grace for disheartened chronic pain patients everywhere.

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