Precise control of tibial nerve stimulation for bladder regulation via evoked compound action potential feedback mechanisms.

Abstract

Optimizing stimulation protocols for peripheral neuromodulation often depends on patient feedback, which can result in inconsistent clinical outcomes. Here we present a closed-loop control system for peripheral nerve stimulation (PNS) that utilizes evoked compound action potential (ECAP) feedback to regulate stimulation parameters, addressing the limitations of traditional methods. Unlike established closed-loop control techniques in the central nervous system, such as local field potential and spike analysis, a comparable approach for the peripheral nervous system remains underdeveloped. ECAPs can be consistently observed across peripheral nerves, providing a reliable measure of nerve activation. We developed a fully implantable device and neural interface for tibial nerve stimulation (TNS) that incorporates the proposed closed-loop system. This TNS system shows promise as a PNS treatment for alleviating overactive bladder symptoms. In a rat model, the system demonstrated longer micturition intervals and greater effectiveness compared to conventional motor response-based control.