Learn About Advanced Neuromodulation
Device Clinical Trial By Ted Swing, Ph.D.
One of the rapidly developing frontiers in the treatment of pain is neuromodulation. Neuromodulation refers to techniques that use electrical pulses to disrupt signals traveling through the nerves. The most widely used forms of neuromodulation target the nerves responsible for sensing pain, though other applications exist for the treatment of conditions such as epileptic seizures, Parkinson’s disease and weight loss. For certain types of pain, disrupting the pain signals results in pain relief. Most types of neuromodulation replace painful sensations with mild, nonpainful tingling sensation.
Types of Neuromodulation Devices
There are several types of neuromodulation devices. Some target nerves of the spinal cord or brain (central nerves), whereas others target the nerves that branch off from the central nerves and sense pain throughout the rest of the body (peripheral nerves). All of the various peripheral nerves send signals back through the central nerves to the brain. Depending on the type of pain and its location(s), there can be advantages to neuromodulation of central or peripheral nerves.
Spinal Cord Stimulation. The first type of neuromodulation device, developed in 1968, is called a spinal cord stimulator (SCS). Spinal cord stimulators are devices implanted under the skin along the spine. The device consists of a battery and pulse generator, along with electrodes running along the spinal nerves. These electrodes are positioned to stimulate the specific nerves for the area or areas where that patient has pain. These devices have proven effective and remain in use.
Transcutaneous Electrical Nerve Stimulation. Transcutaneous electrical nerve stimulation (TENS) is another type of neuromodulation device. Unlike a spinal cord stimulator, it is worn entirely outside of the body. A TENS unit includes a battery and pulse generator, as well as patches placed on the skin — generally in the area of pain — which send electrical pulses through the skin to the nerves beneath the patches. This can alleviate pain in that area.
Peripheral Nerve Stimulation. Similar to spinal cord stimulators, peripheral nerve stimulators (PNS) include a lead implanted beneath the skin. The difference is that, with PNS, the lead targets a branch of a single nerve outside of the spine. This can help patients whose pain is limited to a specific peripheral nerve.
New Clinical Trial
St. Jude has developed a new neuromodulation device of a different type, called a peripheral nerve field stimulator (PNfS). Like a peripheral nerve stimulator, this device targets nerves outside of the spine. However, some patients experience peripheral nerve pain across an area affected by multiple nerves. PNfS is designed to target multiple peripheral nerves in a particular area of the body. St. Jude is already a creator of some of the most advanced spinal cord stimulators and other neuromodulation devices in the world. However, for some patients, a spinal cord stimulator can only relieve the pain in part of their body. For example, some patients suffer from pain both in their lower back and pain that radiates down into the legs, and are not able to get pain relief from other treatments. Some studies have found that these patients get more complete relief by combining a spinal cord stimulator with a peripheral nerve field stimulator either instead of or in addition to a spinal cord stimulator.
To test this application of their new peripheral nerve field stimulator, St. Jude is launching the SENSE (Subcutaneous and Epidural Neuromodulation System Evaluation) Study late this summer. Arizona Pain Specialists will be one of the sites taking part in this clinical trial. This study will enroll patients who suffer from certain types of pain (low back pain and leg pain, or low back pain alone) and have not gotten adequate relief from other treatments including back surgery. These patients will be randomly assigned to receive SCS, PNfS, or both SCS and PNfS. This study will determine if PNfS provides additional pain relief for certain patients.
Ted Swing has more than nine years of research experience and four years of teaching experience in psychology, has published in top psychology and medical journals, and has presented his research at major conferences. He received his Ph.D. in social psychology from Iowa State University and has been the research director at Pain Doctor since May 2012.