Principles of Physiological Closed-Loop Controllers in Neuromodulation
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.
Keywords
Cite
@article{arxiv.2508.11422,
title = {Principles of Physiological Closed-Loop Controllers in Neuromodulation},
author = {Victoria S. Marks and Joram vanRheede and Dean Karantonis and Rosana Esteller and David Dinsmoor and John Fleming and Barrett Larson and Lane Desborough and Peter Single and Robert Raike and Pierre-Francois DHaese and Dario J. Englot and Scott Lempka and Richard North and Lawrence Poree and Marom Bikson and Tim J. Denison},
journal= {arXiv preprint arXiv:2508.11422},
year = {2025}
}
Comments
36 pages, 10 figures