Rapid development of an integrated remote programming platform for neuromodulation systems through the biodesign process.

Treating chronic symptoms for pain and movement disorders with neuromodulation therapies involves fine-tuning of programming parameters over several visits to achieve and maintain symptom relief. This, together with challenges in access to trained specialists, has led to a growing need for an integrated wireless remote care platform for neuromodulation devices. In March of 2021, we launched the first neuromodulation device with an integrated remote programming platform. Here, we summarize the biodesign steps taken to identify the unmet patient need, invent, implement, and test the new technology, and finally gain market approval for the remote care platform. Specifically, we illustrate how agile development aligned with the evolving regulatory requirements can enable patient-centric digital health technology in neuromodulation, such as the remote care platform. The three steps of the biodesign process applied for remote care platform development are: (1) Identify, (2) Invent, and (3) Implement. First, we identified the unmet patient needs through market research and voice-of-customer (VOC) process. Next, during the concept generation phase of the invention step, we integrated the results from the VOC into defining requirements for prototype development. Subsequently, in the concept screening phase, ten subjects with PD participated in a clinical pilot study aimed at characterizing the safety of the remote care prototype. Lastly, during the implementation step, lessons learned from the pilot experience were integrated into final product development as new features. Following final product development, we completed usability testing to validate the full remote care system and collected preliminary data from the limited market release experience. The VOC data, during prototype development, helped us identify thresholds for video quality and needs priorities for clinicians and patients. During the pilot study, one subject reported anticipated remote-care-related adverse events that were resolved without sequelae. For usability analysis following final product development, the failure rates for task completion for both user groups were about 1%. Lastly, during the initial 4 weeks of the limited market release experience, a total of 858 remote care sessions were conducted with a 93% success rate. Overall, we developed a remote care platform by adopting a user-centric approach. Although the system intended to address pre-COVID19 challenges associated with disease management, the unforeseen overlap of the study with the pandemic elevated the importance of such a system and an innovative development process enabled us to advance a patient-centric platform to gain regulatory approval and successfully launch the remote care platform to market.

Flexibility within working memory and the focus of attention for sequential verbal information does not depend on active maintenance.

The focus of attention seems to be a static element within working memory when verbal information is serially presented, unless additional time is available for processing or active maintenance. Experiment 1 manipulated the reward associated with early and medial list positions in a probe recognition paradigm and found evidence that these nonterminal list positions could be retrieved faster and more accurately if participants were appropriately motivated-without additional time for processing or active maintenance. Experiment 2 used articulatory suppression and demonstrated that the underlying maintenance mechanism cannot be attributed to rehearsal, leaving attentional refreshing as the more likely mechanism. These findings suggest that the focus of attention within working memory can flexibly maintain nonterminal early and medial list representations at the expense of other list representations even when there is not additional time for processing or active maintenance. Maintenance seems to be accomplished through an attentional refreshing mechanism.

Simultaneous attentional guidance by working-memory and selection history reveals two distinct sources of attention.

Recent theories of attention have proposed that selection history is a separate, dissociable source of information that influences attention. The current study sought to investigate the simultaneous involvement of selection history and working-memory on attention during visual search. Experiments 1 and 2 used target feature probability to manipulate selection history and found significant effects of both working-memory and selection history, although working-memory dominated selection history when they cued different locations. Experiment 3 eliminated the contribution of voluntary refreshing of working-memory and replicated the main effects, although selection history became dominant. Using the same methodology, but with reduced probability cue validity, both effects were present in Experiment 4 and did not significantly differ in their contribution to attention. Effects of selection history and working-memory never interacted. These results suggest that selection history and working-memory are separate influences on attention and have little impact on each other. Theoretical implications for models of attention are discussed.

The influence of spatial and feature probability cuing in visual search.

Certain aspects of a visual search task, such as the location where a target often appears, are learned over time and can serve as a source of attentional guidance. An example ofthis implicit learning, spatial probability cuing speeds detection of targets that appear in probable locations. The current study investigated target feature probability learning and its relation to implicit spatial probability learning. Results reveal that individuals are sensitive to small changes in the spatial probability of targets, even incidentally learning moderate probabilities. However, feature-based probability differences impacted visual search times much less. Implications for these findings are discussed.

Evidence for a positive relationship between working-memory capacity and detection of low-prevalence targets in visual search.

Our ability to detect a target in visual search relates to the prevalence of the target, whereby rare targets are missed more than common targets. The current study sought to identify operator characteristics that could account for the higher miss rates associated with rare targets. The results found that working-memory capacity, which is strongly related to attentional control and inhibition of irrelevant information, was significantly correlated with the ability to detect low-prevalence targets. High-capacity observers also exhibited lengthened target-absent responses with rare targets, suggesting that the high-capacity observers were more persistent in their searches than others.

False feedback increases detection of low-prevalence targets in visual search.

Many critical search tasks, such as airport and medical screening, involve searching for targets that are rarely present. These low-prevalence targets are associated with extremely high miss rates Wolfe, Horowitz, & Kenner (Nature, 435, 439-440, 2005). The inflated miss rates are caused by a criterion shift, likely due to observers attempting to equate the numbers of misses and false alarms. This equalizing strategy results in a neutral criterion at 50 % target prevalence, but leads to a higher proportion of misses for low-prevalence targets. In the present study, we manipulated participants' perceived number of misses through explicit false feedback. As predicted, the participants in the false-feedback condition committed a higher number of false alarms due to a shifted criterion. Importantly, the participants in this condition were also more successful in detecting targets. These results highlight the importance of perceived prevalence in target search tasks.

The harder the task, the more inconsistent the performance: a PPT analysis on task difficulty.

Previous research has demonstrated that as task difficulty increases, task performance subsequently decreases. These decrements in task performance as difficulty increases have been attributed to the processes individuals use to complete tasks. Over a series of three experiments, Potential Performance Theory (PPT; Trafimow & Rice, 2008 ; 2009), was used to test the hypothesis that decreases in task performance are, in part, due to inconsistency rather than only systematic factors. Task difficulty was manipulated in three visual search tasks by increasing set size (Experiment 1), decreasing contrast (Experiment 2), and increasing background distracters (Experiment 3). Findings over the three studies indicated that decreases in observed task performance as task difficulty increases are primarily due to a decrease of consistency rather than systematic factors. The theoretical implications of these findings are discussed.