Differential target multiplexed spinal cord stimulation using a paddle-type lead placed at the appropriate site for neuropathic pain after spinal cord injury in patients with past spinal surgical histories: study protocol for an exploratory clinical trial

Abstract

Background Neuropathic pain after spinal cord injury (SCI), both traumatic and non-traumatic, is refractory to various treatments. Spinal cord stimulation (SCS) is one of the neuromodulation therapies for neuropathic pain, although SCS has insufficient efficacy for neuropathic pain after SCI. The reasons are presumed to be inappropriate locations of SCS leads and conventional tonic stimulation itself does not have a sufficient analgesic effect for the pain. In patients with past spinal surgical histories, the cylinder-type leads are likely to be placed on the caudal side of the SCI because of surgical adhesions. Differential target multiplexed (DTM) stimulation is one of the latest new stimulation patterns that is superior to conventional stimulation. Methods A single-center, open-label, randomized, two-way crossover trial is planned to investigate the efficacy of SCS using DTM stimulation placing a paddle lead at the appropriate site for neuropathic pain after SCI in patients with spinal surgical histories. The paddle-type lead delivers energy more efficiently than a cylinder-type lead. This study consists of two steps: SCS trial (first step) and SCS system implantation (second step). The primary outcome is rates of achieving pain improvement with more than 33% reduction 3 months after SCS system implantation. The secondary outcomes are to be evaluated as follows: (1) effectiveness of DTM and tonic stimulations during the SCS trial; (2) changes of assessment items from 1 to 24 months; (3) relationships between the result of the SCS trial and the effects 3 months after SCS system implantation; (4) preoperative factors associated with a long-term effect, defined as continuing for more than 12 months; and (5) whether gait function improves from 1 to 24 months. Discussion A paddle-type lead placed on the rostral side of SCI and using DTM stimulation may provide significant pain relief for patients with intractable neuropathic pain after SCI in patients with past spinal surgical histories. Trial registration Japan Registry of Clinical Trials (jRCT) jRCT 1042220093. Registered on 21 November 2022, and last modified on 6 January 2023. jRCT is approved as a member of the Primary Registry Network of WHO ICTRP.

Unintentionally intentional: unintended effects of spinal stimulation as a platform for multi-modal neurorehabilitation after spinal cord injury

“…These studies ranged in publication date from 1988–2023. Additionally, we identified 2 clinical trial protocols that plan to incorporate multi-modal outcome measures (Darrow et al 2022 ; Tanei et al 2023 ). These protocols are not included in the figures or analyses presented below (unless explicitly stated otherwise) because trial results are not available at present.…”

“…1 A). And of the aforementioned clinical trial protocols, 1 trial intends to enroll people living with sensorimotor complete SCI (Darrow et al 2022 ) and 1 trial intends to enroll people living with sensorimotor incomplete SCI (Tanei et al 2023 ).…”

“…These protocols are not included in the figures or analyses presented below (unless explicitly stated otherwise) because trial results are not available at present. Of the 36 manuscripts reviewed below, 13 detailed spinal stimulation paradigms specifically conceptualized to afford multi-modal rehabilitation benefits (Tanei et al 2023;Aslan et al 2018;Harkema et al 2018;Herrity et al 2020;DiMarco et al 2021;Bandres et al 2022Bandres et al , 2023aKandhari et al 2022;McPherson and Bandres 2023;Shelyakin et al 2000;Nightingale et al 2019;Gorgey et al 2023;West et al 2018). The remaining 23 manuscripts reported unintended effects of spinal stimulation paradigms designed to enhance one sensorimotor or autonomic consequence of SCI alone (Harkema et al 2011(Harkema et al , 2018Barolat et al 1988;Katz et al 1991;Loubser 1997;DiMarco et al 2009DiMarco et al , 2018DiMarco et al , 2019Gad et al 2017;Mercier et al 2017;Murray and Knikou 2017;Inanici et al 2018Inanici et al , 2021Walter et al 2018;Darrow et al 2019;Sayenko et al 2019;Hofstoetter et al 2020;Beck et al 2021; Hoey et al 2021;Herrity et al 2022;Ganley et al 2005;Sachdeva et al 2021;Wu et al 2020).…”

Efficacy of the latest new stimulation patterns of spinal cord stimulation for intractable neuropathic pain compared to conventional stimulation: study protocol for a clinical trial

“…The reason is that such patients may have adhesions around past spinal surgeries that make it difficult to pass the cylinder-type leads. Such patients will be enrolled in our other concurrent prospective clinical study [ 29 ]. In the concurrent study, treatment success is defined as a greater than 33% improvement in pain relief.…”