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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
54
High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation
Center of Neurology and Hertie Institute for Clinical Brain Research, Department for Neurodegenerative Diseases and Neurosurgery University of Tübingen
Tübingen, Baden-Wurttemberg, Germany
RECRUITINGLudwig-Maximilians-University Munich, Klinikum Großhadern, Department for Neurology and Neurosurgery
Freezing of Gait Assessment Course (FOG-AC)
Time frame: Outcome at day 90 (V6) with reference to baseline (V1)
Timed Walking test from Core Assessment Program for Surgical Interventions in Parkinson's disease (CAPSIT-PD)
Time frame: At baseline, day 2, 8, 21, 42 and 90, respectively
Berg Balance Scale
Time frame: At baseline, day 42 and 90, respectively
Parkinson's disease questionnaire (PDQ-39)
Time frame: At baseline, day 42 and 90, respectively
Freezing of gait questionnaire
Time frame: At baseline, day 42 and 90, respectively
Beck's depression Inventory
Time frame: At baseline, day 42 and 90, respectively
Columbia-Suicide Severity Rating Scale
Time frame: At baseline, day 42 and 90, respectively
Clinical global impression scale
Time frame: At day 42 and 90, respectively
Falls diary
Time frame: At baseline, day 2, 8, 21, 42 and 90, respectively
Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS III)
Time frame: At baseline, day 2, 8, 21, 42 and 90, respectively
Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS II)
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Munich, Bavaria, Germany
University Hospital Regensburg , Department for Neurology and Neurosurgery
Regensburg, Bavaria, Germany
RECRUITINGUniversity Hospital Köln, Department for Neurology and Neurosurgery
Cologne, North Rhine-Westphalia, Germany
RECRUITINGUniversity Hospital of Düsseldorf, Departments for Neurology and Neurosurgery
Düsseldorf, North Rhine-Westphalia, Germany
RECRUITINGUniversity Hospital Leipzig, Department for Neurology and Neurosurgery
Leipzig, Saxony, Germany
RECRUITINGUniversity Hospital Kiel, Department for Neurology and Neurosurgery
Kiel, Schleswig-Holstein, Germany
RECRUITINGCharite- University Hospital Berlin, Departments for Neurology and Neurosurgery
Berlin, Germany
RECRUITINGUniversity Hospital Hamburg-Eppendorf, Department for Neurology and Neurosurgery
Hamburg, Germany
RECRUITINGUniversity Hospital Luxembourg, Department for Neurology and Neurosurgery
Luxembourg, Luxembourg
RECRUITINGTime frame: At baseline, day 42 and 90, respectively
Movement Disorders Society Unified Parkinson's disease Rating Scale (MDS-UPDRS IV)
Time frame: At baseline, day 42 and 90, respectively
Freezing of Gait Assessment Course (FOG-AC)
To determine treatment kinematics
Time frame: At baseline, day 2, 8, 21, 42 after active treatment (STN vs. STN+SNr), respectively