Journal article : Review
Principles of physiologic closed-loop controllers in neuromodulation
- Abstract:
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Rationale:
As neurostimulation devices increasingly incorporate closed-loop functionality, the greater design complexity brings additional requirements for risk management and special considerations to optimize benefit. This manuscript creates a common framework on which all current and planned neuromodulation-based physiologic 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, a classification of feedback (reactive) and feedforward (predictive) biomarkers, and control systems theory.
Results and Conclusions:
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.
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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- Files:
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(Preview, Version of record, pdf, 11.7MB, Terms of use)
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- Publisher copy:
- 10.1016/j.neurom.2026.03.010
Authors
+ NIHR Oxford Musculoskeletal Biomedical Research Centre
More from this funder
- Funder identifier:
- https://ror.org/00aps1a34
- Grant:
- NIHR203316
- Publisher:
- Elsevier
- Journal:
- Neuromodulation: Technology at the Neural Interface More from this journal
- Volume:
- 29
- Issue:
- 5
- Pages:
- 679-700
- Place of publication:
- United States
- Publication date:
- 2026-04-29
- Acceptance date:
- 2026-03-02
- DOI:
- EISSN:
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1525-1403
- ISSN:
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1094-7159
- Pmid:
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42059841
- Language:
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English
- Keywords:
- Subtype:
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Review
- Pubs id:
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2413769
- Local pid:
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pubs:2413769
- Source identifiers:
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W7158554470
- Deposit date:
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2026-07-21
- ARK identifier:
Terms of use
- Copyright holder:
- Marks et al.
- Copyright date:
- 2026
- Rights statement:
- © 2026 The Authors. Published by Elsevier Inc. on behalf of the International Neuromodulation Society. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).
- Licence:
- CC Attribution (CC BY)
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