Objective: To evaluate whether directional STN DBS is more effective than ring-mode DBS in reducing PD motor symptoms, and to investigate if directional STN DBS has the potential to cause fewer stimulation-induced side-effects.

Background: DBS therapy is oftentimes restricted by side-effects caused by electrical current overspill into areas of the brain adjacent to the target areas. Recently, new DBS electrodes have been developed which are able to achieve a certain degree of steering of the electrical current.

Methods: The study will be a randomized, single-center, prospective, double-blind, crossover trial comparing two forms of STN deep brain stimulation settings: ‘classical’ ring-mode stimulation and directional stimulation. A total of 102 patients will be included. Patients with advanced PD who have been bilaterally implanted with Boston® Vercise™ DBS electrodes in the subthalamic nucleus in our hospital will be eligible for participation after receiving six months of standard therapy. After a period of optimizing directional mode settings, patients will be randomized to receive both steered and ring-mode stimulation in consecutive periods of two months in random order. A subgroup analysis will be performed to evaluate whether good DBS responders and suboptimal DBS responders score differently on primary and secondary endpoints.

Results: Primary endpoints will be the difference in motor symptoms improvement in patients with directional vs ring-mode DBS in standardized OFF-drug phase measured with the Movement Disorders Society Unified Parkinson Disease Rating Scale motor evaluation (MDS-UPDRS-ME). Secondary endpoints will be the used stimulation settings, Levodopa Equivalent Dose, stimulation-induced side-effects, problems with activities of daily living (MDS-UPDRS-ADL), dyskinesias (MDS-UPDRS-MC-A), Quality of Life (PDQ39), and blind choice of therapy at the end of the trial.

Conclusions: With this trial, we aim to answer the question of whether or not directional STN DBS is more effective than the classical ring-mode, and if so, in which domains.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/steered-vs-ring-mode-deep-brain-stimulation-for-parkinsons-disease-steering-trial/