Session Information
Date: Saturday, October 6, 2018
Session Title: Parkinson’s Disease: Clinical Trials, Pharmacology And Treatment
Session Time: 1:45pm-3:15pm
Location: Hall 3FG
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.
To cite this abstract in AMA style:
T. ten Brinke, V. Odekerken, J. Dijk, P. vd Munckhof, P. Schuurman, R. de Bie. STEEred vs RING-mode Deep Brain Stimulation for Parkinson’s disease: STEERING trial [abstract]. Mov Disord. 2018; 33 (suppl 2). https://www.mdsabstracts.org/abstract/steered-vs-ring-mode-deep-brain-stimulation-for-parkinsons-disease-steering-trial/. Accessed September 7, 2024.« Back to 2018 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/steered-vs-ring-mode-deep-brain-stimulation-for-parkinsons-disease-steering-trial/