Abstract

Utilization of objective neurophysiological measures to guide clinicians in providing optimal spinal cord stimulation (SCS) for chronic pain patients is a novel concept to neuromodulation. This clear and transparent mechanistic approach provides a better understanding to clinicians, patients, and payors allowing for proper evaluation of clinical outcomes. A novel SCS system delivers evoked-compound action potentials (ECAPs)-based therapy to 1) Guide programming and confirm activation of the intended target (i.e., ECAP-guided programming); and 2) Deliver closed-loop therapy to maintain accurate and consistent neural activation on every stimulus (i.e., ECAP-controlled closed-loop SCS). This therapy has now been studied in a 24-month double-blind randomized controlled trial (RCT) with self-selected crossover through 36 months. ECAP-based therapy enables real-time collection of continuous, objective, in-vivo neurophysiological data. This provides proper evaluation of the therapy and interpretation of the clinical outcomes, resulting in a level of evidence unmatched in neuromodulation.

Full Text
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