Parkinson's Disease Clinical Trial
Official title:
Combined Stimulation of Subthalamic Nucleus and Substantia Nigra Pars Reticulata for Resistant Freezing of Gait in Parkinson's Disease: A Randomized Controlled Multicenter Trial
54 patients with idiopathic Parkinson's disease and freezing of gait resistant to subthalamic nucleus stimulation and dopaminergic medication will be included into this multicentre randomised controlled double-blinded parallel group clinical trial. The treatment consists of two different stimulation settings using (i) conventional stimulation of the subthalamic nucleus [standard STN] as active comparator and (ii) combined stimulation of active electrode contacts located in both the subthalamic nucleus and substantia nigra pars reticulata [STN+SNr].
The primary endpoint of this study is to investigate the efficacy and safety of combined
[STN+SNr] stimulation by "interleaving stimulation" as compared to [standardSTN] after 3
months on refractory freezing of gait (FOG). 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 (Ziegler et al., 2010) with one-tailed P < 0.2. To this end 54 patients will be
studied. After a common baseline assessment in [standardSTN], patients will be randomized to
either [standardSTN] or [STN+SNr] in 1:1 ratio (27 per arm). The primary endpoint assessment
is scheduled 90 days from baseline assessment (V6). Additional interim visits are scheduled
for secondary purpose from baseline at day 2 (V2), day 8 (V3), day 21 (V4), day 42 (V5).
The rationale for this study comes from our previous phase II trial (Weiss et al., 2013) in
which we have observed an improvement of freezing of gait from combined STN+SNr stimulation
as secondary endpoint compared with standard STN stimulation at three-week follow-up.
Secondary outcome measures include anamnestic assessments on freezing of gait and falls,
balance, quality of life, neuropsychiatric symptoms and suicidality.
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