Visions on the future of medical devices in spinal cord stimulation: what medical device is needed?

Abstract

Recently burst stimulation and 10 kHz stimulation have been developed as novel stimulation designs. Both appear to be superior to classical tonic stimulation in the amount of responders and the amount of pain suppression and have as an extra advantage that they are paresthesia-free. This evolution is very important as it shifts the focus of research from better targeting by developing new lead configurations to better communication with the nervous system. It can be envisioned that this is only the start of a new trend in spinal cord, brain, and peripheral nerve stimulation and that more new stimulation designs will be developed in the near future such as pseudorandom burst stimulation, pleasure stimulation, noise stimulation and reconditioning stimulation. This evolution mandates a new approach in the development of internal pulse generators, and the most obvious approach is to develop an upgradable stimulator, on which new stimulation designs can be downloaded, analogous to the apps people download on their smartphones. This will create a shift from hardware driven products to software driven stimulators.

Functional magnetic resonance imaging: cerebral function alterations in subthreshold and suprathreshold spinal cord stimulation

“… 4 , 5 From a clinical perspective, two different approaches entered daily practice: implanting the electrode base on 1) the anatomy (midline, with hotspot T9–T10) and 2) intraoperative stimulation covering the painful area with paresthesia. 6 – 9 The thread that links both treatment strategies is the great interest in paresthesia-free stimulation 10 –defined as sub-threshold stimulation: the patient does not feel any directly linked sensory input from the stimulator (paresthesia), but the initial pain is reduced. Aside from high-frequency stimulation (HF10), both burst and high-density (HD) stimulation paradigms are based on intraoperative stimulation wherein pulse intensity is kept just below the sensory threshold.…”

Intrathecal Therapeutics: Device Design, Access Methods, and Complication Mitigation

“…The last several years have seen a number of new percutaneous epidural electrode arrays and stimulation‐parameter configurations brought to market, along with many others in the product development pipeline, that have and will continue to significantly enhance the standard methods of spinal cord stimulation . The electrode configuration that will offer the most selectivity and support the greatest range of stimulation parameters may prove best , but other considerations such as power consumption , ability to upgrade the implanted stimulator , and ease of use by the patient will also be factors in device recommendations for each clinical case. Sorting through which will work best for any given indication will undoubtedly take time, and include careful evaluations of quality‐of‐life improvement and economic considerations .…”

State of the Art: Novel Applications for Cortical Stimulation

“…One of the problems with cortex stimulation is habituation to the stimulation , requiring multiple reprogramming sessions, which could be prevented by developing stimulation designs that have some form of pseudorandomness embedded , as it is expected that the brain cannot habituate to a constantly changing stimulation, in which a signal is embedded, for example, by using structured noise electrical stimulation .…”