An integrated remote care platform for deep brain stimulation patient programming: Safety and feasibility study

ABSTRACT

Objective: NA Background: Deep Brain Stimulation (DBS), an effective therapy for Parkinson's Disease (PD), requires reliable access to trained neurologists, experienced in managing DBS therapy, and specialty care centers, typically located in dense cities. This contributes to increased care access burden for patients residing in distant areas. Here, we investigated a remote care platform that enabled experts to adjust DBS therapy settings in real-time via a secure video-based mobile platform. Design/Methods: This study was designed to prospectively evaluate the feasibility and safety of an investigational remote care platform, developed in alignment with established data and security standards. PD patients, implanted with an Infinity™ DBS system, were enrolled in the study. The primary endpoint of this study was to determine remote care feasibility and safety by evaluating adverse events With in 3 weeks of the programming session conducted at the randomization visit. At the randomization visit, ten subjects connected with their clinician through the secure remote care platform where the clinician could modulate and save updated DBS programming parameters. Results: At the 3-week primary endpoint, one subject experienced diminished therapy, an adverse event that was resolved without sequalae. Remote changes in programming included modulating amplitude, frequency, pulse-width and contact selection. Further, the clinician was able to make changes from variable settings (a different room in-clinic, a remote urban or a rural setting). Conclusions: Previous studies have shown that telemedicine is a potential strategy to improve care access. The current COVID-19 pandemic has emphasized the need to address this imminent challenge of safely accessing health care options. In this study, we characterized the safety and feasibility of our remote care platform, an integrated telemedicine option for PD patients. Evaluation of such remote care platforms advances the field towards low-burden therapy options for patients, clinicians, and government agencies in the rapidly emerging digital health realm.