RESUMEN
Technological advances of Deep Brain Stimulation (DBS) within the subthalamic nucleus (STN) for Parkinson's disease (PD) provide increased programming options with higher programming burden. Reducing the effort of DBS optimization requires novel programming strategies. The objective of this study was to evaluate the feasibility of a semi-automatic algorithm-guided-programming (AgP) approach to obtain beneficial stimulation settings for PD patients with directional DBS systems. The AgP evaluates iteratively the weighted combination of sensor and clinician assessed responses of multiple PD symptoms to suggested DBS settings until it converges to a final solution. Acute clinical effectiveness of AgP DBS settings and DBS settings that were found following a standard of care (SoC) procedure were compared in a randomized, crossover and double-blind fashion in 10 PD subjects from a single center. Compared to therapy absence, AgP and SoC DBS settings significantly improved (p = 0.002) total Unified Parkinson's Disease Rating Scale III scores (median 69.8 interquartile range (IQR) 64.6|71.9% and 66.2 IQR 58.1|68.2%, respectively). Despite their similar clinical results, AgP and SoC DBS settings differed substantially. Per subject, AgP tested 37.0 IQR 34.0|37 settings before convergence, resulting in 1.7 IQR 1.6|2.0 h, which is comparable to previous reports. Although AgP long-term clinical results still need to be investigated, this approach constitutes an alternative for DBS programming and represents an important step for future closed-loop DBS optimization systems.
RESUMEN
BACKGROUND: Recent technological advances in deep brain stimulation (DBS) (e.g., directional leads, multiple independent current sources) lead to increasing DBS-optimization burden. Techniques to streamline and facilitate programming could leverage these innovations. OBJECTIVE: We evaluated clinical effectiveness of algorithm-guided DBS-programming based on wearable-sensor-feedback compared to standard-of-care DBS-settings in a prospective, randomized, crossover, double-blind study in two German DBS centers. METHODS: For 23 Parkinson's disease patients with clinically effective DBS, new algorithm-guided DBS-settings were determined and compared to previously established standard-of-care DBS-settings using UPDRS-III and motion-sensor-assessment. Clinical and imaging data with lead-localizations were analyzed to evaluate characteristics of algorithm-derived programming compared to standard-of-care. Six different versions of the algorithm were evaluated during the study and 10 subjects programmed with uniform algorithm-version were analyzed as a subgroup. RESULTS: Algorithm-guided and standard-of-care DBS-settings effectively reduced motor symptoms compared to off-stimulation-state. UPDRS-III scores were reduced significantly more with standard-of-care settings as compared to algorithm-guided programming with heterogenous algorithm versions in the entire cohort. A subgroup with the latest algorithm version showed no significant differences in UPDRS-III achieved by the two programming-methods. Comparing active contacts in standard-of-care and algorithm-guided DBS-settings, contacts in the latter had larger location variability and were farther away from a literature-based optimal stimulation target. CONCLUSION: Algorithm-guided programming may be a reasonable approach to replace monopolar review, enable less trained health-professionals to achieve satisfactory DBS-programming results, or potentially reduce time needed for programming. Larger studies and further improvements of algorithm-guided programming are needed to confirm these results.
