Language

English

Publication Date

12-19-2025

Journal

Journal of Neural Engineering

DOI

10.1088/1741-2552/ae2359

PMID

41285049

PMCID

PMC12715846

PubMedCentral® Posted Date

12-19-2025

PubMedCentral® Full Text Version

Post-print

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.

Keywords

Humans, Brain-Computer Interfaces, Animals, Equipment Design, Implantable Neurostimulators

Published Open-Access

yes

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