Principles of Physiological Closed-Loop Controllers in Neuromodulation

Victoria S. Marks; Joram vanRheede; Dean Karantonis; Rosana Esteller; David Dinsmoor; John Fleming; Barrett Larson; Lane Desborough; Peter Single; Robert Raike; Pierre-Francois DHaese; Dario J. Englot; Scott Lempka; Richard North; Lawrence Poree; Marom Bikson; Tim J. Denison

arXiv · 2508.11422

Principles of Physiological Closed-Loop Controllers in Neuromodulation

Victoria S. Marks·Joram vanRheede·Dean Karantonis·Rosana Esteller·David Dinsmoor·John Fleming·Barrett Larson·Lane Desborough·Peter Single·Robert Raike·Pierre-Francois DHaese·Dario J. Englot·Scott Lempka·Richard North·Lawrence Poree·Marom Bikson·Tim J. Denison

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Abstract

As neurostimulation devices increasingly incorporate closed-loop functionality, the greater design complexity brings additional requirements for risk management and special considerations to optimise benefit. This manuscript creates a common framework upon which all current and planned neuromodulation-based physiological closed-loop controllers (PCLCs) can be mapped including integration of the Technical Considerations of Medical Devices with Physiologic Closed-Loop Control Technology guidance published in 2023 by the United States Food and Drug Administration (FDA), a classification of feedback (reactive) and feedforward (predictive) biomarkers, and control systems theory. We explain risk management in the context of this framework and illustrate its applications for three exemplary technologies. This manuscript serves as guidance to the emerging field of PCLCs in neuromodulation, mitigating risk through standardized nomenclature and a systematic outline for rigorous device development, testing, and implementation.

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Victoria S. Marks, Joram vanRheede, Dean Karantonis, Rosana Esteller, David Dinsmoor, John Fleming, Barrett Larson, Lane Desborough, Peter Single, Robert Raike, Pierre-Francois DHaese, Dario J. Englot, Scott Lempka, Richard North, Lawrence Poree, Marom Bikson, Tim J. Denison. 2025-12-04. Principles of Physiological Closed-Loop Controllers in Neuromodulation. https://arxiv.org/abs/2508.11422

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