@article {4450, title = {Towards clinical application of implantable brain-computer interfaces for people with late-stage ALS: medical and ethical considerations.}, journal = {J Neurol}, volume = {270}, year = {2023}, month = {03/2023}, pages = {1323-1336}, 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.

}, keywords = {Amyotrophic Lateral Sclerosis, brain-computer interfaces, Electroencephalography, Humans, Self-Help Devices, Speech}, issn = {1432-1459}, doi = {10.1007/s00415-022-11464-6}, author = {Vansteensel, Mariska J and Klein, Eran and van Thiel, Ghislaine and Gaytant, Michael and Simmons, Zachary and Wolpaw, Jonathan R and Vaughan, Theresa M} } @article {4298, title = {Brain-computer interfaces for people with amyotrophic lateral sclerosis}, journal = {Handbook of Clinical Neurology}, volume = {168}, year = {2020}, month = {03/2020}, chapter = {33}, abstract = {A brain-computer interface (BCI) records and extracts features from brain signals, and translates these features into commands that can replace, restore, enhance, supplement, or improve natural CNS outputs. As demonstrated in the other chapters of this book, the focus of the work of the last three decades of BCI research has been the replacement, restoration, or improvement of diminished or lost function in people with CNS disease or injury including those with amyotrophic lateral sclerosis (ALS). Due in part to the desire to conduct controlled studies, and, in part, to the complexity of BCI technology, most of this work has been carried out in laboratories with healthy controls or with limited numbers of potential consumers with a variety of diagnoses under supervised conditions. The intention of this chapter is to describe the growing body of BCI research that has included people with amyotrophic lateral sclerosis (ALS). People in the late stages of ALS can lose all voluntary control, including the ability to communicate; and while recent research has provided new insights into underlying mechanisms, ALS remains a disease with no cure. As a result, people with ALS and their families, caregivers, and advocates have an active interest in both the current and potential capabilities of BCI technology. The focus of BCI research for people with ALS is on communication, and this topic is well covered elsewhere in this volume. This chapter focuses on the efforts dedicated to make BCI technology useful to people with ALS in their daily lives with a discussion of how researchers, clinicians, and patients must become partners in that process.}, keywords = {Amyotrophic Lateral Sclerosis, Augmentative and alternative communication, Electroencephalography}, doi = {10.1016/B978-0-444-63934-9.00004-4}, url = {https://www.sciencedirect.com/science/article/pii/B9780444639349000044}, author = {T. Vaughan} } @article {4367, title = {Enhancing Communication for People in Late-Stage ALS Using an fNIRS-Based BCI System.}, journal = {IEEE Trans Neural Syst Rehabil Eng}, volume = {28}, year = {2020}, month = {05/2020}, pages = {1198-1207}, abstract = {

OBJECTIVE: Brain-computer interface (BCI) based communication remains a challenge for people with later-stage amyotrophic lateral sclerosis (ALS) who lose all voluntary muscle control. Although recent studies have demonstrated the feasibility of functional near-infrared spectroscopy (fNIRS) to successfully control BCIs primarily for healthy cohorts, these systems are yet inefficient for people with severe motor disabilities like ALS. In this study, we developed a new fNIRS-based BCI system in concert with a single-trial Visuo-Mental (VM) paradigm to investigate the feasibility of enhanced communication for ALS patients, particularly those in the later stages of the disease.

METHODS: In the first part of the study, we recorded data from six ALS patients using our proposed protocol (fNIRS-VM) and compared the results with the conventional electroencephalography (EEG)-based multi-trial P3Speller (P3S). In the second part, we recorded longitudinal data from one patient in the late locked-in state (LIS) who had fully lost eye-gaze control. Using statistical parametric mapping (SPM) and correlation analysis, the optimal channels and hemodynamic features were selected and used in linear discriminant analysis (LDA).

RESULTS: Over all the subjects, we obtained an average accuracy of 81.3\%{\textpm}5.7\% within comparatively short times (< 4 sec) in the fNIRS-VM protocol relative to an average accuracy of 74.0\%{\textpm}8.9\% in the P3S, though not competitive in patients with no substantial visual problems. Our longitudinal analysis showed substantially superior accuracy using the proposed fNIRS-VM protocol (73.2\%{\textpm}2.0\%) over the P3S (61.8\%{\textpm}1.5\%).

SIGNIFICANCE: Our findings indicate the potential efficacy of our proposed system for communication and control for late-stage ALS patients.

}, keywords = {Amyotrophic Lateral Sclerosis, brain-computer interfaces, Communication, Electroencephalography, Humans, Spectroscopy, Near-Infrared}, issn = {1558-0210}, doi = {10.1109/TNSRE.2020.2980772}, author = {Borgheai, Seyyed Bahram and McLinden, John and Zisk, Alyssa Hillary and Hosni, Sarah Ismail and Deligani, Roohollah Jafari and Abtahi, Mohammadreza and Mankodiya, Kunal and Shahriari, Yalda} } @article {3370, title = {Brain-computer interface (BCI) evaluation in people with amyotrophic lateral sclerosis.}, journal = {Amyotroph Lateral Scler Frontotemporal Degener}, volume = {15}, year = {2014}, month = {06/2014}, pages = {207-15}, abstract = {Brain-computer interfaces (BCIs) might restore communication to people severely disabled by amyotrophic lateral sclerosis (ALS) or other disorders. We sought to: 1) define a protocol for determining whether a person with ALS can use a visual P300-based BCI; 2) determine what proportion of this population can use the BCI; and 3) identify factors affecting BCI performance. Twenty-five individuals with ALS completed an evaluation protocol using a standard 6 {\texttimes} 6 matrix and parameters selected by stepwise linear discrimination. With an 8-channel EEG montage, the subjects fell into two groups in BCI accuracy (chance accuracy 3\%). Seventeen averaged 92 ({\textpm} 3)\% (range 71-100\%), which is adequate for communication (G70 group). Eight averaged 12 ({\textpm} 6)\% (range 0-36\%), inadequate for communication (L40 subject group). Performance did not correlate with disability: 11/17 (65\%) of G70 subjects were severely disabled (i.e. ALSFRS-R < 5). All L40 subjects had visual impairments (e.g. nystagmus, diplopia, ptosis). P300 was larger and more anterior in G70 subjects. A 16-channel montage did not significantly improve accuracy. In conclusion, most people severely disabled by ALS could use a visual P300-based BCI for communication. In those who could not, visual impairment was the principal obstacle. For these individuals, auditory P300-based BCIs might be effective.}, keywords = {Adult, Aged, Amyotrophic Lateral Sclerosis, Biofeedback, Psychology, brain-computer interfaces, Communication Disorders, Electroencephalography, Event-Related Potentials, P300, Female, Humans, Male, Middle Aged, Online Systems, Photic Stimulation, Psychomotor Performance, Reaction Time}, issn = {2167-9223}, doi = {10.3109/21678421.2013.865750}, url = {http://www.ncbi.nlm.nih.gov/pubmed/24555843}, author = {McCane, Lynn M and Sellers, Eric W and Dennis J. McFarland and Mak, Joseph N and Carmack, C Steve and Zeitlin, Debra and Jonathan Wolpaw and Theresa M Vaughan} } @article {2131, title = {Transition from the locked in to the completely locked-in state: a physiological analysis.}, journal = {Clin Neurophysiol}, volume = {122}, year = {2011}, month = {06/2011}, pages = {925-33}, abstract = {

OBJECTIVE:\ 

To clarify the physiological and behavioral boundaries between locked-in (LIS) and the completely locked-in state (CLIS) (no voluntary eye movements, no communication possible) through electrophysiological data and to secure\ brain-computer-interface\ (BCI) communication.

METHODS:\ 

Electromyography from facial muscles, external anal sphincter (EAS), electrooculography and electrocorticographic data during different psychophysiological tests were acquired to define electrophysiological differences in an amyotrophic lateral sclerosis (ALS) patient with an intracranially implanted grid of 112 electrodes for nine months while the patient passed from the LIS to the CLIS.

RESULTS:\ 

At the very end of the LIS there was no facial muscle activity, nor external anal sphincter but eye control. Eye movements were slow and lasted for short periods only. During CLIS event related\ brainpotentials (ERP) to passive limb movements and auditory stimuli were recorded, vibrotactile stimulation of different body parts resulted in no ERP response.

CONCLUSIONS:\ 

The results presented contradict the commonly accepted assumption that the EAS is the last remaining muscle under voluntary control and demonstrate complete loss of eye movements in CLIS. The eye muscle was shown to be the last muscle group under voluntary control. The findings suggest ALS as a multisystem disorder, even affecting afferent sensory pathways.

SIGNIFICANCE:\ 

Auditory and proprioceptive\ brain-computer-interface\ (BCI) systems are the only remaining communication channels in CLIS.

}, keywords = {Adult, Amyotrophic Lateral Sclerosis, Area Under Curve, Brain, Communication Aids for Disabled, Disease Progression, Electroencephalography, Electromyography, Humans, Male, Signal Processing, Computer-Assisted, User-Computer Interface}, issn = {1872-8952}, doi = {10.1016/j.clinph.2010.08.019}, url = {http://www.ncbi.nlm.nih.gov/pubmed/20888292}, author = {Murguialday, A Ramos and Jeremy Jeremy Hill and Bensch, M and Martens, S M M and S Halder and Nijboer, F and Schoelkopf, Bernhard and Niels Birbaumer and Gharabaghi, A} } @article {3199, title = {A P300-based brain-computer interface for people with amyotrophic lateral sclerosis.}, journal = {Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology}, volume = {119}, year = {2008}, month = {08/2008}, pages = {1909{\textendash}1916}, abstract = {OBJECTIVE: The current study evaluates the efficacy of a P300-based brain-computer interface (BCI) communication device for individuals with advanced ALS. METHODS: Participants attended to one cell of a N x N matrix while the N rows and N columns flashed randomly. Each cell of the matrix contained one character. Every flash of an attended character served as a rare event in an oddball sequence and elicited a P300 response. Classification coefficients derived using a stepwise linear discriminant function were applied to the data after each set of flashes. The character receiving the highest discriminant score was presented as feedback. RESULTS: In Phase I, six participants used a 6 x 6 matrix on 12 separate days with a mean rate of 1.2 selections/min and mean online and offline accuracies of 62\% and 82\%, respectively. In Phase II, four participants used either a 6 x 6 or a 7 x 7 matrix to produce novel and spontaneous statements with a mean online rate of 2.1 selections/min and online accuracy of 79\%. The amplitude and latency of the P300 remained stable over 40 weeks. CONCLUSIONS: Participants could communicate with the P300-based BCI and performance was stable over many months. SIGNIFICANCE: BCIs could provide an alternative communication and control technology in the daily lives of people severely disabled by ALS.}, keywords = {Amyotrophic Lateral Sclerosis, brain-computer interface, electroencephalogram, event-related potentials, P300, Rehabilitation}, issn = {1388-2457}, doi = {10.1016/j.clinph.2008.03.034}, url = {http://www.ncbi.nlm.nih.gov/pubmed/18571984}, author = {Nijboer, F. and Sellers, E. W. and Mellinger, J. and Jordan, M. A. and Matuz, T. and Adrian Furdea and S Halder and Mochty, U. and Krusienski, D. J. and Theresa M Vaughan and Jonathan Wolpaw and Niels Birbaumer and K{\"u}bler, A.} } @article {3134, title = {A P300 event-related potential brain-computer interface (BCI): the effects of matrix size and inter stimulus interval on performance.}, journal = {Biological psychology}, volume = {73}, year = {2006}, month = {10/2006}, pages = {242{\textendash}252}, abstract = {We describe a study designed to assess properties of a P300 brain-computer interface (BCI). The BCI presents the user with a matrix containing letters and numbers. The user attends to a character to be communicated and the rows and columns of the matrix briefly intensify. Each time the attended character is intensified it serves as a rare event in an oddball sequence and it elicits a P300 response. The BCI works by detecting which character elicited a P300 response. We manipulated the size of the character matrix (either 3 x 3 or 6 x 6) and the duration of the inter stimulus interval (ISI) between intensifications (either 175 or 350 ms). Online accuracy was highest for the 3 x 3 matrix 175-ms ISI condition, while bit rate was highest for the 6 x 6 matrix 175-ms ISI condition. Average accuracy in the best condition for each subject was 88\%. P300 amplitude was significantly greater for the attended stimulus and for the 6 x 6 matrix. This work demonstrates that matrix size and ISI are important variables to consider when optimizing a BCI system for individual users and that a P300-BCI can be used for effective communication.}, keywords = {Amyotrophic Lateral Sclerosis, brain-computer interface, electroencephalogram, event-related potentials, P300, Rehabilitation}, issn = {0301-0511}, doi = {10.1016/j.biopsycho.2006.04.007}, url = {http://www.ncbi.nlm.nih.gov/pubmed/16860920}, author = {Sellers, Eric W. and Krusienski, Dean J. and Dennis J. McFarland and Theresa M Vaughan and Jonathan Wolpaw} } @article {2169, title = {Patients with ALS can use sensorimotor rhythms to operate a brain-computer interface.}, journal = {Neurology}, volume = {64}, year = {2005}, month = {05/2005}, pages = {1775-7}, abstract = {

People with severe motor disabilities can maintain an acceptable quality of life if they can communicate.\ Brain-computer interfaces\ (BCIs), which do not depend on muscle control, can provide communication. Four people severely disabled by ALS learned to operate a BCI with EEG rhythms recorded over sensorimotor cortex. These results suggest that a sensorimotor rhythm-based\ BCI could help maintain quality of life for people with ALS.

}, keywords = {Aged, Amyotrophic Lateral Sclerosis, Electroencephalography, Evoked Potentials, Motor, Evoked Potentials, Somatosensory, Female, Humans, Imagination, Male, Middle Aged, Motor Cortex, Movement, Paralysis, Photic Stimulation, Prostheses and Implants, Somatosensory Cortex, Treatment Outcome, User-Computer Interface}, issn = {1526-632X}, doi = {10.1212/01.WNL.0000158616.43002.6D}, url = {http://www.ncbi.nlm.nih.gov/pubmed/15911809}, author = {K{\"u}bler, A. and Nijboer, F and Mellinger, J{\"u}rgen and Theresa M Vaughan and Pawelzik, H and Gerwin Schalk and Dennis J. McFarland and Niels Birbaumer and Jonathan Wolpaw} } @article {2167, title = {The BCI Competition 2003: Progress and perspectives in detection and discrimination of EEG single trials.}, journal = {IEEE Trans Biomed Eng}, volume = {51}, year = {2004}, month = {06/2004}, pages = {1044-51}, abstract = {Interest in developing a new method of man-to-machine communication--a brain-computer interface (BCI)--has grown steadily over the past few decades. BCIs create a new communication channel between the brain and an output device by bypassing conventional motor output pathways of nerves and muscles. These systems use signals recorded from the scalp, the surface of the cortex, or from inside the brain to enable users to control a variety of applications including simple word-processing software and orthotics. BCI technology could therefore provide a new communication and control option for individuals who cannot otherwise express their wishes to the outside world. Signal processing and classification methods are essential tools in the development of improved BCI technology. We organized the BCI Competition 2003 to evaluate the current state of the art of these tools. Four laboratories well versed in EEG-based BCI research provided six data sets in a documented format. We made these data sets (i.e., labeled training sets and unlabeled test sets) and their descriptions available on the Internet. The goal in the competition was to maximize the performance measure for the test labels. Researchers worldwide tested their algorithms and competed for the best classification results. This paper describes the six data sets and the results and function of the most successful algorithms.}, keywords = {Adult, Algorithms, Amyotrophic Lateral Sclerosis, Artificial Intelligence, Brain, Cognition, Databases, Factual, Electroencephalography, Evoked Potentials, Humans, Reproducibility of Results, Sensitivity and Specificity, User-Computer Interface}, issn = {0018-9294}, doi = {10.1109/TBME.2004.826692}, author = {Benjamin Blankertz and M{\"u}ller, Klaus-Robert and Curio, Gabriel and Theresa M Vaughan and Gerwin Schalk and Jonathan Wolpaw and Schl{\"o}gl, Alois and Neuper, Christa and Pfurtscheller, Gert and Hinterberger, T. and Schr{\"o}der, Michael and Niels Birbaumer} }