Next-Generation SCS Programming Platform: Enhancing ECAP Fidelity and Objectivity to Improve Patient Experience

Evoked compound action potentials (ECAPs) are neurophysiological biomarkers of neural activation during spinal cord stimulation (SCS). Clear distinction between ECAPs and nonphysiological signals is critical to the application of contemporary, ECAP-based closed-loop (CL) SCS therapies. Herein, we evaluated the performance and user acceptability of a novel programming software that automates generation of ECAP-based CL-SCS programs-the Assisted Programming Module (APM).

We report results from two prospective, multicenter, single-arm, feasibility studies: Freshwater (NCT04662905) and Rosella (NCT06057480). APM performance was compared with the previous generation programming software and other published methods. Performance was assessed by comparing signal-to-noise ratios, artifact rejection, and other objective parameters. User acceptability was assessed using questionnaires administered to SCS users.

The APM successfully generated a CL program in 96% of initial programming sessions (n = 81/84; Freshwater, 31/34; Rosella, 50/50). In the Rosella study, median time to generate an automated CL program (n = 68) was 11.9 min [interquartile range (IQR) 9.9-14.0]. Median dose ratio was 1.31 (IQR 1.20-1.46) at end of trial (n = 24), 1.34 (IQR 1.13-1.51) at 1 month post implant (n = 16), and 1.32 (IQR 1.21-1.48) at 3 months post implant (n = 15). At least 90% of patients [trial, 90% (27/30); implant, 94% (17/18)] were satisfied with their programming experience, and ≥ 90% of patients [trial, 90% (26/29); implant, 94% (16/17)] felt in control of their therapy. The APM achieved a mean signal-to-noise ratio of 4.6 ± 1.2, a 35% improvement over the previous generation ECAP dose-controlled CL-SCS system. Detectable artifact leakage rates decreased by 75% when compared with other published methods without compromise to signal-to-noise performance.

Next-generation ECAP dose-controlled CL technology demonstrated strong feasibility, high patient satisfaction and therapy control, and superior ECAP signal fidelity compared with existing methods. By standardizing CL-SCS programming and enhancing signal fidelity, the APM may improve workflow efficiency and long-term therapy outcomes in chronic pain management.

ClinicalTrials.gov identifiers: NCT04662905, NCT06057480.