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

Area of Science:

• Neuroscience
• Biomedical Engineering
• Pain Management

Background:

• Evoked compound action potentials (ECAPs) are crucial biomarkers for neural activation in spinal cord stimulation (SCS).
• Accurate distinction between ECAPs and non-physiological signals is essential for advanced ECAP-based closed-loop (CL) SCS therapies.
• The Assisted Programming Module (APM) is a novel software designed to automate the generation of ECAP-based CL-SCS programs.

Purpose of the Study:

• To evaluate the performance of the novel Assisted Programming Module (APM) software in generating ECAP-based CL-SCS programs.
• To assess the user acceptability and satisfaction with the APM among SCS users.
• To compare the APM's performance against previous generation programming software and other published methods.

Main Methods:

• Two prospective, multicenter, single-arm feasibility studies (Freshwater and Rosella) were conducted.
• APM performance was objectively assessed by comparing signal-to-noise ratios and artifact rejection rates.
• User acceptability was evaluated through questionnaires administered to SCS patients.

Main Results:

• The APM successfully generated CL programs in 96% of initial sessions.
• The median time to generate an automated CL program was 11.9 minutes.
• Over 90% of patients reported satisfaction with the programming experience and felt in control of their therapy.
• The APM achieved a 35% improvement in signal-to-noise ratio and a 75% reduction in artifact leakage compared to existing methods.

Conclusions:

• Next-generation ECAP dose-controlled CL technology, via the APM, shows high feasibility and patient satisfaction.
• The APM demonstrates superior ECAP signal fidelity compared to current methods.
• Standardized programming and enhanced signal fidelity with the APM may improve workflow efficiency and long-term outcomes in chronic pain management.