Session Information
Date: Thursday, June 23, 2016
Session Title: Clinical trials and therapy in movement disorders
Session Time: 12:00pm-1:30pm
Location: Exhibit Hall located in Hall B, Level 2
Objective: 54 patients with idiopathic Parkinson’s disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this German-wide multicenter randomised controlled double-blinded parallel group clinical trial (initiating center: University of Tübingen; collaborating centers: Universities of Berlin, Düsseldorf, Hamburg, Köln, Leipzig, Luxemburg, München, Regensburg; alphabetical order).
Background: Freezing of gait presents as major unmet need in advanced Parkinson’s disease with often-poor treatment response to dopaminergic treatment and conventional neurostimulation therapy. Novel treatment strategies are warranted.
Methods: The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus ‘standard STN’ as active comparator and (ii) combined interleaving stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata ‘STN+SNr’. Patients are randomized in 1:1 ratio after the common baseline assessment in ‘standard STN’. As primary outcome, we hypothesize on superiority of ‘STN+SNr’ on freezing of gait at 90 days follow-up. The trial is designed as superiority study with an 80% power to detect a mean improvement of 4.7 points on the Freezing of Gait Assessment Course with ‘STN+SNr’ as compared to ‘standard STN’ with one-tailed P < 0.2. Additionally, we schedule four additional interim visits on freezing of gait and motor symptoms to explore the treatment kinetics. Both patient and rater will be kept blinded to the treatment regimen. The trial was registered at ClinTrials.gov (NCT02588144).
Results: The trial is currently active and recruiting. We expect results in 2018.
Conclusions: We introduce our multicenter randomized controlled trial on combined ‘STN+SNr’ for resistant freezing of gait. Additionally, this trial will provide differentiated insight into the treatment kinetics of combined ‘STN+SNr’ treatment.
To cite this abstract in AMA style:
D. Weiss, G. Naros, C. Meisner, R. Krüger, A. Gharabaghi. Combined stimulation of STN and SNr for resistant freezing of gait in Parkinson’s disease (STN+SNr) – A multicenter randomized controlled trial [abstract]. Mov Disord. 2016; 31 (suppl 2). https://www.mdsabstracts.org/abstract/combined-stimulation-of-stn-and-snr-for-resistant-freezing-of-gait-in-parkinsons-disease-stnsnr-a-multicenter-randomized-controlled-trial/. Accessed May 16, 2025.« Back to 2016 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/combined-stimulation-of-stn-and-snr-for-resistant-freezing-of-gait-in-parkinsons-disease-stnsnr-a-multicenter-randomized-controlled-trial/