Methodological Recommendations for Studies on the Daily Life Implementation of Implantable Communication-Brain–Computer Interfaces for Individuals With Locked-in Syndrome
Vansteensel, Mariska J.; Branco, Mariana P.; Leinders, Sacha; Freudenburg, Zac F.; Schippers, Anouck; Geukes, Simon H.; Gaytant, Michael A.; Gosselaar, Peter H.; Aarnoutse, Erik J.; Ramsey, Nick F.
(2022) Neurorehabilitation and Neural Repair, volume 36, issue 10-11, pp. 666 - 677
(Article)
Abstract
Implantable brain–computer interfaces (BCIs) promise to be a viable means to restore communication in individuals with locked-in syndrome (LIS). In 2016, we presented the world-first fully implantable BCI system that uses subdural electrocorticography electrodes to record brain signals and a subcutaneous amplifier to transmit the signals to the outside world,
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and that enabled an individual with LIS to communicate via a tablet computer by selecting icons in spelling software. For future clinical implementation of implantable communication-BCIs, however, much work is still needed, for example, to validate these systems in daily life settings with more participants, and to improve the speed of communication. We believe the design and execution of future studies on these and other topics may benefit from the experience we have gained. Therefore, based on relevant literature and our own experiences, we here provide an overview of procedures, as well as recommendations, for recruitment, screening, inclusion, imaging, hospital admission, implantation, training, and support of participants with LIS, for studies on daily life implementation of implantable communication-BCIs. With this article, we not only aim to inform the BCI community about important topics of concern, but also hope to contribute to improved methodological standardization of implantable BCI research.
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Keywords: amyotrophic lateral sclerosis, brain–computer interfaces, electrodes, home environment, implanted, methods, reference standard, Rehabilitation, Neurology, Clinical Neurology
ISSN: 1545-9683
Publisher: SAGE Publications Inc.
Note: Funding Information: The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded by the National Institute on Deafness and Other Communication Disorders (U01DC016686) and the National Institute of Neurological Disorders and Stroke (UH3NS114439) of the National Institutes of Health, the Dutch Research Council (INTENSE, 17619) and the Dutch Government (UGT7685, Economic Affairs SSM06011 and STW 12803, investigator-initiated study where Medtronic provided financial support and devices). The funding sources were not involved in the design or writing of this manuscript. Funding Information: The authors thank the staff of the ICU, anesthesiology, radiology, clinical neurophysiology, neurology, and neurosurgery departments and the Center for Home Ventilation of the UMCU for their help in the design and execution of the UNP study. The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This research was funded by the National Institute on Deafness and Other Communication Disorders (U01DC016686) and the National Institute of Neurological Disorders and Stroke (UH3NS114439) of the National Institutes of Health, the Dutch Research Council (INTENSE, 17619) and the Dutch Government (UGT7685, Economic Affairs SSM06011 and STW 12803, investigator-initiated study where Medtronic provided financial support and devices). The funding sources were not involved in the design or writing of this manuscript. Publisher Copyright: © The Author(s) 2022.
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