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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^TM 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 within 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.

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).