Preprint Article Version 1 Preserved in Portico This version is not peer-reviewed

The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, Through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment. A Real-Life Retrospective Cohort Analysis

Version 1 : Received: 15 October 2021 / Approved: 18 October 2021 / Online: 18 October 2021 (10:04:52 CEST)

How to cite: Rigoard, P.; Ounajim, A.; Goudman, L.; Banor, T.; Héroux, F.; Roulaud, M.; Babin, E.; Bouche, B.; Page, P.; Lorgeoux, B.; Baron, S.; Adjali, N.; Nivole, K.; Many, M.; Charrier, E.; Rannou, D.; Poupin, L.; Wood, C.; David, R.; Moens, M.; Billot, M. The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, Through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment. A Real-Life Retrospective Cohort Analysis. Preprints 2021, 2021100235 (doi: 10.20944/preprints202110.0235.v1). Rigoard, P.; Ounajim, A.; Goudman, L.; Banor, T.; Héroux, F.; Roulaud, M.; Babin, E.; Bouche, B.; Page, P.; Lorgeoux, B.; Baron, S.; Adjali, N.; Nivole, K.; Many, M.; Charrier, E.; Rannou, D.; Poupin, L.; Wood, C.; David, R.; Moens, M.; Billot, M. The Challenge of Converting “Failed Spinal Cord Stimulation Syndrome” Back to Clinical Success, Using SCS Reprogramming as Salvage Therapy, Through Neurostimulation Adapters Combined with 3D-Computerized Pain Mapping Assessment. A Real-Life Retrospective Cohort Analysis. Preprints 2021, 2021100235 (doi: 10.20944/preprints202110.0235.v1).

Abstract

While paresthesia-based spinal cord stimulation (SCS) has been proven effective to treat chronic neuropathic pain, initial benefits may lead to the development of “Failed SCS Syndrome’ (FSCSS) defined as decrease over time related to Loss of Efficacy (LoE) with or without Loss of Coverage (LoC). Development of technologies associating new paresthesia-free stimulation waveforms and implanted pulse generator adapters provide opportunities to manage patients with LoE. The main goal of our study was to investigate salvage procedures, through neu-rostimulation adapters, in patients already implanted with SCS and experienced LoE. We retro-spectively analyzed a cohort of patients who were offered new SCS programs/waveforms through an implanted adapter between 2018 and 2021. Patients were evaluated before, and at 1, 3, 6 and 12-month follow-up. Outcomes included pain intensity rating with Visual Analog Scale (VAS), pain/coverage mappings and stimulation preferences. Last follow-up evaluations (N=27) showed significant improvement in VAS (p = 0.0001), ODI (p = 0.021) and Quality of Life (p=0.023). In the 11/27 patients with LoC, SCS efficacy on pain intensity (36.89%) was accompa-nied by paresthesia coverage recovery (55.57%) and pain surface decrease (47.01%). At 12-month follow-up, 81.3% preferred to keep tonic stimulation in their waveform portfolio. SCS conver-sion using adapters appears promising as a salvage solution, with an emphasis on paresthesia recapturing enabled by spatial retargeting. In light of these results, adapters could be integrated to SCS rescue algorithms or should be considered in SCS rescue.

Keywords

Spinal Cord Stimulation; rescue therapy; salvage therapy; new waveforms; paresthesia-free waveforms; High-Frequency stimulation; Burst stimulation; spatial neural targeting; temporal neural targeting; SCS programming; adapter; mapping software; paresthesia coverage; patient outcome; salvage algorithm

Subject

MEDICINE & PHARMACOLOGY, General Medical Research

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