Neuromodulation : journal of the International Neuromodulation Society
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Randomized Controlled Trial
Redefining Spinal Cord Stimulation "Trials": A Randomized Controlled Trial Using Single-Stage Wireless Permanent Implantable Devices.
"Traditional" spinal cord stimulation (SCS) trials with percutaneous electrodes externalized to a pulse generator (PG) are typically limited in duration due to risk of infection. Newer miniaturized wireless SCS technology eliminates the percutaneous extension (as well as PGs implanted for chronic use), thus facilitating a single-stage implantation after which the device can remain indefinitely. ⋯ Using wireless SCS devices that allow for an extended trial period and evaluation of various waveforms, we observed a high rate trial success rate with both HFS and LFS waveforms, with minimal incidence of infection. Long-term follow-up will address the cost-effectiveness and morbidity associated with this technology, which facilitates single-stage treatment.
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Observational Study
Predictors of Reduced Opioid Use With Spinal Cord Stimulation in Patients With Chronic Opioid Use.
Spinal cord stimulation (SCS) has gained traction as an alternative to chronic opioid therapy in light of the opioid crisis. Prior reports vary widely in their estimates of its effect on opioid consumption. We therefore aimed to address the following questions: 1) Does chronic opioid use change after SCS? 2) Which patient characteristics predict reduced opioid consumption after SCS? ⋯ With only half of chronic opioid users demonstrating meaningful opioid reduction after SCS implantation, we demonstrate that current SCS technology does not reliably help a larger number of patients reduce opioid usage. Women, older age, and preoperative MED < 65 are predictive of meaningful opioid reduction but only one of these is modifiable. As not all patients saw benefit from their therapies, there is still much room for improvement in the treatment of refractory chronic pain that is associated with failed back surgery syndrome and chronic regional pain syndrome.
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Apart from the clinical efficacy of high frequency spinal cord stimulation at 10 kHz, the underlying mechanism of action remains unclear. In parallel with spinal or segmental theories, supraspinal hypotheses have been recently proposed. In order to unveil hidden altered brain connectome patterns, a resting state functional magnetic resonance imaging (rsfMRI) protocol was performed in subjects routinely treated for back and/or leg pain with high-frequency spinal cord stimulation (HF-SCS) HF-SCS at 10 kHz. ⋯ These findings support the hypothesis that HF-SCS at 10 kHz might influence the salience network and therefore also the emotional awareness of pain.
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The electrically evoked compound action potential (ECAP) is a measure of the response from a population of fibers to an electrical stimulus. ECAPs can be assessed during spinal cord stimulation (SCS) to elucidate the relationship between stimulation, electrophysiological response, and neuromodulation. This has consequences for the design and programming of SCS devices. ⋯ John Parker is the founder and CEO of Saluda Medical and holds stock options. Milan Obradovic, Nastaran Hesam Shariati, Dean M. Karantonis, Peter Single, James Laird-Wah, Robert Gorman and Mark Bickerstaff are employees of Saluda Medical with stock options. At the time the data was collected for the study, Prof. Cousins was a paid consultant for Saluda Medical. John Parker, Milan Obradovic, Dean Karantonis, James Laird-Wah, Robert Gorman and Peter Single are co-inventors in one or more patents related to the topics discussed in this work.