Towards clinical application of implantable brain–computer interfaces for people with late-stage ALS: medical and ethical considerations

Abstract

Individuals with amyotrophic lateral sclerosis (ALS) frequently develop speech and communication problems in the course of their disease. Currently available augmentative and alternative communication technologies do not present a solution for many people with advanced ALS, because these devices depend on residual and reliable motor activity. Brain–computer interfaces (BCIs) use neural signals for computer control and may allow people with late-stage ALS to communicate even when conventional technology falls short. Recent years have witnessed fast progression in the development and validation of implanted BCIs, which place neural signal recording electrodes in or on the cortex. Eventual widespread clinical application of implanted BCIs as an assistive communication technology for people with ALS will have significant consequences for their daily life, as well as for the clinical management of the disease, among others because of the potential interaction between the BCI and other procedures people with ALS undergo, such as tracheostomy. This article aims to facilitate responsible real-world implementation of implanted BCIs. We review the state of the art of research on implanted BCIs for communication, as well as the medical and ethical implications of the clinical application of this technology. We conclude that the contribution of all BCI stakeholders, including clinicians of the various ALS-related disciplines, will be needed to develop procedures for, and shape the process of, the responsible clinical application of implanted BCIs.

Applying the IEEE BRAIN neuroethics framework to intra-cortical brain-computer interfaces

“…It is important to remark that currently, all iBCIs are only available in the context of clinical trial research; there are no non-investigational iBCIs that are available yet for clinical purposes, and accordingly, no iBCI has yet received Food and Drug Administration approval for clinical use, although several have received investigational device exemptions to be studied in the context of clinical trials (see supplementary table 1 for a list of known commercial entities in Europe and US who are developing iBCIs) [42] While iBCIs are currently mainly confined to the research domain, the ongoing advancements in technology and neuroscience indicate that BCIs will eventually transition into the clinical domain. This will enable clinicians to offer them to individuals who are at risk of losing or have already lost their ability to communicate and/or move [43]. The process of providing an iBCI to a user, currently in the context of a research study, is complex and requires a multidisciplinary approach involving healthcare professionals, BCI specialists, the user, and their support system.…”

“…people who experienced an acute event, stroke, or injury who may still be going through their emotional journey post trauma). Researchers, caregivers, and clinicians must be sensitive to the opinions of prospective end-users while also taking into consideration that the users need sufficient time to learn how to use the technology and to decide if they want to use it and which one if multiple possibilities are available [43,66]. iBCI candidates and users need continued care and attention from caregivers and clinicians, which can involve balancing authority and decision-making.…”

Use of 3D Printing Techniques to Fabricate Implantable Microelectrodes for Electrochemical Detection of Biomarkers in the Early Diagnosis of Cardiovascular and Neurodegenerative Diseases

“…Patients may have concerns about the use of their data in the development of personalized medical devices. In addition, there may be questions about the accessibility and affordability of personalized medical devices, particularly for patients in low-income countries. , Additionally, ethical concerns related to data privacy, informed consent, and potential misuse of the technology should be carefully considered and addressed to ensure the responsible development and deployment of these devices …”

“…265,266 Additionally, ethical concerns related to data privacy, informed consent, and potential misuse of the technology should be carefully considered and addressed to ensure the responsible development and deployment of these devices. 267…”

Towards EEG-to-Text: Handwritten Character Classification via Continuous Kinematic Decoding

“…Individuals with spinal-cord injuries are inhibited primarily in their execution of daily activities and require, among other things, the restoration of actual movement execution. Patients with locked-in syndrome or similar medical conditions, however, additionally experience severe impairments in their communication abilities and require foremost reliable methods for the interaction with relatives and caretakers ( Vansteensel et al, 2023 ). Over the last years, the restoration of comunication channels for these patients has seen extensive progress driven by advances in the field of brain-computer interfaces (BCIs).…”