Adaptive neuromodulation dialogues: navigating current challenges and emerging innovations in neuromodulation system development

Adaptive neuromodulation systems and implantable brain-computer interfaces have made notable strides in recent years, translating experimental prototypes into clinical applications and garnering substantial attention from the public. This surge in interest is accompanied by increased scrutiny related to the safety, efficacy, and ethical implications of these systems, all of which must be directly addressed as we introduce new neurotechnologies. In response, we have synthesized the insights resulting from discussions between groups of experts in the field and summarized them into five key domains essential to therapeutic device development: (1) analyzing current landscape of neuromodulation devices and translational platforms (2) identifying clinical need, (3) understanding neural mechanisms, (4) designing viable technologies, and (5) addressing ethical concerns. The role of translational research platforms that allow rapid, iterative testing of hypotheses in both preclinical and clinical settings is emphasized. These platforms must balance experimental flexibility with patient safety and clear clinical benefit. Furthermore, requirements for interoperability, modularity, and wireless communication protocols are explored to support long-term usability and scalability. The current regulatory processes and funding models are examined alongside the ethical responsibilities of researchers and device manufacturers. Special attention is given to the role of patients as active contributors to research and to the long-term obligations we have to them as the primary burden-bearers of the implanted neurotechnologies. This article represents a synthesis of scientific, engineering, and clinical viewpoints to inform key stakeholders in the neuromodulation and brain-computer interface spaces.

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Publication Details

Journal
Journal of Neural Engineering
Published
2025-11-24
DOI
https://doi.org/10.1088/1741-2552/ae2359
Primary Topic
Neurological disorders and treatments
Type
article
Field-Weighted Citation Impact
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article

Adaptive neuromodulation dialogues: navigating current challenges and emerging innovations in neuromodulation system development

Václav Křemen, C. Bentler, Peter Brunner, Graham W. Johnson et al.
Journal of Neural Engineering
Neurological disorders and treatments
article

Adaptive neuromodulation dialogues: navigating current challenges and emerging innovations in neuromodulation system development

Václav Křemen, C. Bentler, Peter Brunner, Graham W. Johnson, Nuri F. Ince, Jeffrey A. Herron, Enrico Opri, Gerwin Schalk, Kristin K. Sellers, Daryl R. Kipke, Christopher K. Kovach, Timothy Denison, Matthew Baker, Joshua M. Rosenow, Théoden I. Netoff, Chandra Prakash Swamy, Dora Hermes, Kai J. Miller, Michael A. Jensen, Alexander P. Rockhill, Gregory A. Worrell, Rosana Esteller, Filip Mívalt, Joseph S. Neimat, Nathan P. Staff, Amir Hossein Ayyoubi, Jessica L Bowersock, Ashwin Viswanathan, F. Lampert
article en

Abstract

Adaptive neuromodulation systems and implantable brain-computer interfaces have made notable strides in recent years, translating experimental prototypes into clinical applications and garnering substantial attention from the public. This surge in interest is accompanied by increased scrutiny related to the safety, efficacy, and ethical implications of these systems, all of which must be directly addressed as we introduce new neurotechnologies. In response, we have synthesized the insights resulting from discussions between groups of experts in the field and summarized them into five key domains essential to therapeutic device development: (1) analyzing current landscape of neuromodulation devices and translational platforms (2) identifying clinical need, (3) understanding neural mechanisms, (4) designing viable technologies, and (5) addressing ethical concerns. The role of translational research platforms that allow rapid, iterative testing of hypotheses in both preclinical and clinical settings is emphasized. These platforms must balance experimental flexibility with patient safety and clear clinical benefit. Furthermore, requirements for interoperability, modularity, and wireless communication protocols are explored to support long-term usability and scalability. The current regulatory processes and funding models are examined alongside the ethical responsibilities of researchers and device manufacturers. Special attention is given to the role of patients as active contributors to research and to the long-term obligations we have to them as the primary burden-bearers of the implanted neurotechnologies. This article represents a synthesis of scientific, engineering, and clinical viewpoints to inform key stakeholders in the neuromodulation and brain-computer interface spaces.

Journal of Neural EngineeringVol. 22(6)
Northwestern University (US), Seattle Pacific University (US), University of Minnesota (US), Mayo Clinic (US), University of Louisville (US), University of Freiburg (DE), Oregon Health & Science University (US), University of California, San Francisco (US), Baylor College of Medicine (US), Vanderbilt University (US), University of Washington (US), Washington University in St. Louis (US), University of Michigan (US), Boston Scientific (United States) (US), University of Oxford (GB), University of Minnesota Rochester (US), Mayo Clinic in Arizona (US), Science Oxford (GB), Mayo Clinic in Florida (US), Northwestern Medicine (US), Advanced Scientific Concepts (United States) (US), Jenner Institute (GB), Neurological Surgery (US), NeuroNexus (United States) (US), University of Bath (GB), University of Nebraska Medical Center (US)
Openalex Percentile: Top 50%
Neurological disorders and treatments
DOIOpen Access PDFOpenAlex
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