TY - JOUR
T1 - Adaptive neuromodulation dialogues
T2 - navigating current challenges and emerging innovations in neuromodulation system development
AU - Lampert, Frederik
AU - Baker, Matthew R.
AU - Jensen, Michael A.
AU - Ayyoubi, Amir H.
AU - Bentler, Christian
AU - Bowersock, Jessica L.
AU - Esteller, Rosana
AU - Herron, Jeffrey A.
AU - Johnson, Graham W.
AU - Kipke, Daryl R.
AU - Kovach, Christopher K.
AU - Kremen, Vaclav
AU - Mivalt, Filip
AU - Neimat, Joseph S.
AU - Netoff, Theoden I.
AU - Opri, Enrico
AU - Rockhill, Alexander
AU - Rosenow, Joshua M.
AU - Sellers, Kristin K.
AU - Staff, Nathan P.
AU - Swamy, Chandra Prakash
AU - Viswanathan, Ashwin
AU - Schalk, Gerwin
AU - Denison, Timothy
AU - Hermes, Dora
AU - Ince, Nuri F.
AU - Brunner, Peter
AU - Worrell, Gregory A.
AU - Miller, Kai J.
PY - 2025/12/19
Y1 - 2025/12/19
N2 - 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.
AB - 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.
KW - adaptive neuromodulation
KW - closed-loop stimulation
KW - deep brain stimulation (DBS)
KW - implantable brain-computer interface (iBCI)
KW - implantable neural stimulators (INS)
UR - https://www.scopus.com/pages/publications/105025245677
U2 - 10.1088/1741-2552/ae2359
DO - 10.1088/1741-2552/ae2359
M3 - Review article
C2 - 41285049
AN - SCOPUS:105025245677
SN - 1741-2560
VL - 22
JO - Journal of Neural Engineering
JF - Journal of Neural Engineering
IS - 6
M1 - 061005
ER -