DBS-Expert Pro: Automated Deep Brain Stimulation Programming Using Functional Mapping

Summary The objective is to develop DBS-Expert Pro, an expert system for optimizing postoperative programming of deep brain stimulation (DBS) in patients with movement disorders such as Parkinson’s disease (PD), into a commercially viable product. The clinical utility of DBS for PD is well established; however, great outcome disparity exists among recipients due to varied postoperative management, particularly concerning DBS programming optimization. Many programmers have only a cursory understanding of electrophysiology and lack the expertise and/or time required to determine optimal DBS parameters from thousands of possible combinations. DBS-Expert Pro will improve DBS outcomes and equalize care across the country by using intelligent algorithms to optimize DBS settings both in the clinic and at patients’ homes. The system will include automated functional mapping based on objective motion sensor-based motor assessments and intelligent algorithms for resolving an optimal set of programming parameters integrated with clinician and patient programmer devices. In-clinic or at home, automated functional mapping will intelligently navigate the DBS parameter space to guide programming, minimizing clinician time and patient burden while simplifying data collection. Intelligent algorithms will determine a set of programming parameters that optimize efficacy while minimizing side effects and battery usage. This will improve patient outcomes and transfer expert programming strategies to disparate populations who do not have access to specialized DBS centers. We previously developed adaptive DBS programming and search algorithms to automatically identify optimal DBS stimulation parameters, improved the efficiency of our objective Kinesia automated motor assessment, created commercial Android software that includes guided programming and DBS-response visualizations, and deployed the system in a multi-site clinical trial that showed programming using the technology improved UPDRS-III scores by 45% and required testing significantly fewer DBS settings compared to standard programming (p<0.05). The technology was integrated into our Kinesia™ StimPoint™ system, which is commercially distributed by Boston Scientific for helping program its Vercise DBS platform. This program includes several innovations necessary to make the system commercially viable, including 1) direct integration with DBS programmer software, 2) support for programming the newest lead configurations (e.g., directional), and 3) remote programming. Rather than requiring the clinician to manually adjust DBS based on algorithm recommendations from a separate system, we will design the app to run as part of the clinician programmer software, which will shorten programming time and reduce the likelihood of error. Additionally, we will update the system to program the newest directional lead configurations that now dominate the market. Finally, we will upgrade the system to work with remote DBS programming using an app on the patient programmer, reducing travel and equalizing care for those unable to travel to the clinic.