A review of reusable insulin pens and features of TouStar-a new reusable pen with a dedicated cartridge.

BACKGROUND: Since the introduction of the first reusable insulin pen, the advancement in the design of these pens is still ongoing to develop a safe, more efficacious, less painful, and easy to use insulin pen device. MAIN BODY: Possible errors in insulin delivery can occur at any stage of insulin delivery such as during the prescription stage, dispensing stage, or at administration stage. Mismatch of the insulin pen and cartridge is not uncommon and is a potential risk for individuals with diabetes due to serious consequences associated with incorrect insulin usage. The similarities in insulin cartridges of different manufacturers with regard to color and product names could lead to mix-up of insulin pens and cartridges. These unmet needs have led to the ongoing search for developing insulin pens that can address these errors and provide more efficacious and safer choices for patients with diabetes. CONCLUSION: This review provides an overview of currently available reusable pens in the market and highlights the features of TouStar®, a new reusable pen with a dedicated cartridge intended to mitigate the risk of mismatch of the cartridge.

Usability and Workload of Access Technology for People With Severe Motor Impairment: A Comparison of Brain-Computer Interfacing and Eye Tracking.

BACKGROUND: Eye trackers are widely used among people with amyotrophic lateral sclerosis, and their benefits to quality of life have been previously shown. On the contrary, Brain-computer interfaces (BCIs) are still quite a novel technology, which also serves as an access technology for people with severe motor impairment. OBJECTIVE: To compare a visual P300-based BCI and an eye tracker in terms of information transfer rate (ITR), usability, and cognitive workload in users with motor impairments. METHODS: Each participant performed 3 spelling tasks, over 4 total sessions, using an Internet browser, which was controlled by a spelling interface that was suitable for use with either the BCI or the eye tracker. At the end of each session, participants evaluated usability and cognitive workload of the system. RESULTS: ITR and System Usability Scale (SUS) score were higher for the eye tracker (Wilcoxon signed-rank test: ITR T = 9, P = .016; SUS T = 12.50, P = .035). Cognitive workload was higher for the BCI (T = 4; P = .003). CONCLUSIONS: Although BCIs could be potentially useful for people with severe physical disabilities, we showed that the usability of BCIs based on the visual P300 remains inferior to eye tracking. We suggest that future research on visual BCIs should use eye tracking-based control as a comparison to evaluate performance or focus on nonvisual paradigms for persons who have lost gaze control.

An auditory multiclass brain-computer interface with natural stimuli: Usability evaluation with healthy participants and a motor impaired end user.

Brain-computer interfaces (BCIs) can serve as muscle independent communication aids. Persons, who are unable to control their eye muscles (e.g., in the completely locked-in state) or have severe visual impairments for other reasons, need BCI systems that do not rely on the visual modality. For this reason, BCIs that employ auditory stimuli were suggested. In this study, a multiclass BCI spelling system was implemented that uses animal voices with directional cues to code rows and columns of a letter matrix. To reveal possible training effects with the system, 11 healthy participants performed spelling tasks on 2 consecutive days. In a second step, the system was tested by a participant with amyotrophic lateral sclerosis (ALS) in two sessions. In the first session, healthy participants spelled with an average accuracy of 76% (3.29 bits/min) that increased to 90% (4.23 bits/min) on the second day. Spelling accuracy by the participant with ALS was 20% in the first and 47% in the second session. The results indicate a strong training effect for both the healthy participants and the participant with ALS. While healthy participants reached high accuracies in the first session and second session, accuracies for the participant with ALS were not sufficient for satisfactory communication in both sessions. More training sessions might be needed to improve spelling accuracies. The study demonstrated the feasibility of the auditory BCI with healthy users and stresses the importance of training with auditory multiclass BCIs, especially for potential end-users of BCI with disease.

Semantic conditioning of salivary pH for communication.

OBJECTIVES: Semantic conditioning of salivary pH was investigated as a new paradigm for binary communication. METHODS AND MATERIALS: In a sample of eleven healthy participants, affirmation or negation of presented statements were paired with milk and lemon to condition changes in salivary pH level. RESULTS: Significant differences between the conditioned reactions were found at the group level. However, the analysis of pH changes on single-subject level revealed significant differences between affirmative and negative responses to the presented statements only for isolated samples in few participants. When classifying a change in pH value of more than .01 as correct response to a statement, only responses to affirmative statements reached mean accuracies of more than 60%. CONCLUSION: Improvements in the paradigm are necessary before testing it with the critical target population of patients to prove its profit for basic yes/no communication in case no other reliable means of communication could be preserved.

Brain communication in the locked-in state.

Patients in the completely locked-in state have no means of communication and they represent the target population for brain-computer interface research in the last 15 years. Although different paradigms have been tested and different physiological signals used, to date no sufficiently documented completely locked-in state patient was able to control a brain-computer interface over an extended time period. We introduce Pavlovian semantic conditioning to enable basic communication in completely locked-in state. This novel paradigm is based on semantic conditioning for online classification of neuroelectric or any other physiological signals to discriminate between covert (cognitive) 'yes' and 'no' responses. The paradigm comprised the presentation of affirmative and negative statements used as conditioned stimuli, while the unconditioned stimulus consisted of electrical stimulation of the skin paired with affirmative statements. Three patients with advanced amyotrophic lateral sclerosis participated over an extended time period, one of which was in a completely locked-in state, the other two in the locked-in state. The patients' level of vigilance was assessed through auditory oddball procedures to study the correlation between vigilance level and the classifier's performance. The average online classification accuracies of slow cortical components of electroencephalographic signals were around chance level for all the patients. The use of a non-linear classifier in the offline classification procedure resulted in a substantial improvement of the accuracy in one locked-in state patient achieving 70% correct classification. A reliable level of performance in the completely locked-in state patient was not achieved uniformly throughout the 37 sessions despite intact cognitive processing capacity, but in some sessions communication accuracies up to 70% were achieved. Paradigm modifications are proposed. Rapid drop of vigilance was detected suggesting attentional variations or variations of circadian period as important factors in brain-computer interface communication with locked-in state and completely locked-in state.

Amyotrophic lateral sclerosis progression and stability of brain-computer interface communication.

Our objective was to investigate the relationship between brain-computer interface (BCI) communication skill and disease progression in amyotrophic lateral sclerosis (ALS). We sought also to assess stability of BCI communication performance over time and whether it is related to the progression of neurological impairment before entering the locked-in state. A three years follow-up, BCI evaluation in a group of ALS patients (n = 24) was conducted. For a variety of reasons only three patients completed the three years follow-up. BCI communication skill and disability level, using the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised, were assessed at admission and at each of the three follow-ups. Multiple non-parametric statistical methods were used to ensure reliability of the dependent variables: correlations, paired test and factor analysis of variance. Results demonstrated no significant relationship between BCI communication skill (BCI-CS) and disease evolution. The patients who performed the follow-up evaluations preserved their BCI-CS over time. Patients' age at admission correlated positively with the ability to achieve control over a BCI. In conclusion, disease evolution in ALS does not affect the ability to control a BCI for communication. BCI performance can be maintained in the different stages of the illness.

Semantic classical conditioning and brain-computer interface control: encoding of affirmative and negative thinking.

The aim of the study was to investigate conditioned electroencephalography (EEG) responses to factually correct and incorrect statements in order to enable binary communication by means of a brain-computer interface (BCI). In two experiments with healthy participants true and false statements (serving as conditioned stimuli, CSs) were paired with two different tones which served as unconditioned stimuli (USs). The features of the USs were varied and tested for their effectiveness to elicit differentiable conditioned reactions (CRs). After acquisition of the CRs, these CRs to true and false statements were classified offline using a radial basis function kernel support vector machine. A mean single-trial classification accuracy of 50.5% was achieved for differentiating conditioned "yes" versus "no" thinking and mean accuracies of 65.4% for classification of "yes" and 68.8% for "no" thinking (both relative to baseline) were found using the best US. Analysis of the area under the curve of the conditioned EEG responses revealed significant differences between conditioned "yes" and "no" answers. Even though improvements are necessary, these first results indicate that the semantic conditioning paradigm could be a useful basis for further research regarding BCI communication in patients in the complete locked-in state.

A portable auditory P300 brain-computer interface with directional cues.

OBJECTIVES: The main objective of the current study was to implement and evaluate a P300 based brain-computer interface (BCI) speller that uses directional cues of auditory stimuli, which are presented over headphones. The interstimulus interval (ISI) was successively reduced to determine the optimal combination of speed and accuracy. The study further aimed at quantifying the differences in subjective workload between the auditory and the visual P300 spelling application. The influence of workload, mood and motivation on BCI performance and P300 amplitude was investigated. METHODS: Twenty healthy participants performed auditory and visual spelling tasks in an EEG experiment with online feedback. RESULTS: Sixteen of twenty participants performed at or above a level necessary for satisfactory communication (≥70% spelling accuracy) with the auditory BCI. Average bit rates of up to 2.76 bits/min (best subject 7.43 bits/min) were achieved. A significantly higher workload was reported for the auditory speller compared to the visual paradigm. Motivation significantly influenced P300 amplitude at Pz in the auditory condition. CONCLUSIONS: The results of the online study suggest that the proposed paradigm offers a means of communication for most healthy users. SIGNIFICANCE: The described auditory BCI can serve as a communication channel for completely paralyzed patients.

Brain-computer interface and semantic classical conditioning of communication in paralysis.

We propose a classical semantic conditioning procedure to allow basic yes-no communication in the completely locked-in state as an alternative to instrumental-operant learning of brain responses, which is the common approach in brain-computer interface research. More precisely, it was intended to establish cortical responses to the trueness of a statement irrespective of the particular constituent words and letters or sounds of the words. As unconditioned stimulus short aversive stimuli consisting of 1-ms electrical pulses were used. True and false statements were presented acoustically and only the true statements were immediately followed by electrical stimuli. 15 healthy participants and one locked-in ALS patient underwent the experiment. Three different classifiers were employed in order to differentiate between the two cortical responses by means of electroencephalographic recordings. The offline analysis revealed that semantic classical conditioning can be applied successfully to enable basic communication using a non-muscular channel.

Design and implementation of a P300-based brain-computer interface for controlling an internet browser.

An electroencephalographic (EEG) brain-computer interface (BCI) internet browser was designed and evaluated with 10 healthy volunteers and three individuals with advanced amyotrophic lateral sclerosis (ALS), all of whom were given tasks to execute on the internet using the browser. Participants with ALS achieved an average accuracy of 73% and a subsequent information transfer rate (ITR) of 8.6 bits/min and healthy participants with no prior BCI experience over 90% accuracy and an ITR of 14.4 bits/min. We define additional criteria for unrestricted internet access for evaluation of the presented and future internet browsers, and we provide a review of the existing browsers in the literature. The P300-based browser provides unrestricted access and enables free web surfing for individuals with paralysis.