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Article type: Research Article
Authors: Wenzel, Gregor R.a; * | Roediger, Jana; b | Brücke, Christofa; 1 | Marcelino, Ana Luísa de A.a | Gülke, Eileenc | Pötter-Nerger, Monikac | Scholtes, Heleend | Wynants, Kennyd; 2 | Juárez Paz, León M.d | Kühn, Andrea A.a
Affiliations: [a] Department of Neurology, Movement Disorders & Neuromodulation Section, Charité –University Medicine Berlin, Berlin, Germany | [b] Einstein Center for Neurosciences Berlin, Charité –University Medicine Berlin, Berlin, Germany | [c] Department of Neurology, Universitätsklinikum Hamburg-Eppendorf, Hamburg, Germany | [d] Boston Scientific, Valencia, CA, USA
Correspondence: [*] Correspondence to: Gregor R. Wenzel, Department of Neurology, Movement Disorders & Neuromodulation Section, Charité – University Medicine Berlin, Charitéplatz 1, 10117 Berlin, Germany. Tel.: +49 30 450 660 569; E-mail: [email protected].
Note: [1] Present address: Department of Neurology, Medizinische Universität Wien, Spitalgasse 23, 1090 Vienna, Austria. E-mail: [email protected].
Note: [2] Present address: Nyxoah SA, Mont-Saint-Guibert, Belgium.
Abstract: 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.
Keywords: Deep brain stimulation, Parkinson’s disease, algorithm, wearable device feedback, double-blind, subthalamic nucleus
DOI: 10.3233/JPD-202480
Journal: Journal of Parkinson's Disease, vol. 11, no. 4, pp. 1887-1899, 2021
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