Deep brain stimulation (DBS) programming can be time intensive and requires extensive experience. Previous pilot studies have demonstrated that motion sensor-based computer-guided DBS programming can significantly improve symptoms with minimal clinician involvement. We carried out a study to evaluate a novel sensor-based functional mapping (SBFM) medical device system for guiding DBS programming.

Eight participants (6 male, 2 female; Age 53-69 years) with recently implanted multiple independent current control DBS systems for treating Parkinson’s disease (PD) were enrolled. The study followed a randomized, cross-over controlled design. Each participant completed two DBS programming sessions: one using standard programming techniques (SoC) and the other with the aid of the SBFM device, which included algorithm-guided programming, motion sensor-based assessment of tremor or bradykinesia, symptom response map visualizations, and automated identification of optimal settings designed to minimize symptom severities, side-effects, and battery usage.

UPDRS-III assessments were performed by a blinded rater before and after each programming session. The time required to program the DBS system, number of settings tested, and final current levels were measured. SoC and SBFM programming were compared using a Wilcoxon signed-rank test.

Total UPDRS-III scores improved significantly for both SBFM (median 43% improvement, p=0.008) and SoC (median 35% improvement, p=0.008) and there was no statistical difference in improvements between SBFM and SoC. SBFM programming significantly reduced the number of settings tested (median 9 vs 31, p=0.047). Median programming time and final current amplitude were both smaller for SBFM (22 minutes vs 39 minutes, 2.0 mA vs. 2.5 mA), but the differences were not statistically significant.

SBFM had similar outcomes to SoC programming but required fewer settings to be tested, which suggests that SBFM could improve programming efficiency and extend expert programming strategies to populations without access to specialized DBS centers.