Bilateral subthalamic stimulation plus medical therapy results in better overall behavioral outcomes compared with medical therapy alone in patients with Parkinson disease (PD) and early motor complications according to a study published in The Lancet Neurology.
Eugénie Lhommée, MPsych, of the movement disorder unit, neurology department, Centre Hospitalier Universitaire, University Grenoble Alpes in France, and colleagues conducted a parallel, open-label study (EARLYSTIM) at 17 surgical centers in France and Germany. The study included 251 patients with PD disabled by early motor complications who were randomly assigned to medical therapy alone (n=127) or medical therapy plus bilateral subthalamic stimulation (n=124) between July 2006 and November 2009.
The primary outcome was mean change in quality of life (QoL) from baseline to 2 years. A secondary analysis assessed behavioral outcomes using the Ardouin Scale of Behavior in Parkinson Disease to assess changes from baseline to 2-year follow-up. The investigators measured apathy using the Starkstein Apathy Scale and assessed depression using the Beck Depression Inventory.
The investigators used a generalized estimating equations regression model for individual items and mixed model regression for subscores of the Ardouin scale and the apathy and depression scales.
At 2-year follow-up, the levodopa-equivalent dose decreased by 39% in individuals in the bilateral subthalamic stimulation plus medical therapy group and increased by 21% in patients assigned to receive medical therapy alone (P <.0001). Neuropsychiatric fluctuations decreased with bilateral subthalamic stimulation, but did not change with medical therapy alone (mean change −0.65 vs. -0.02; P =.0028). The Ardouin scale subscore for hyperdopaminergic behavioral disorders decreased at 2 years with bilateral subthalamic stimulation (mean change −1.26 points) and increased with medical therapy alone (1.12 points). The between-group difference was significant (P <.0001). However, mean change from baseline at 2 years in the Ardouin scale subscore for hypodopaminergic behavioral disorders, the Starkstein Apathy Scale score, and the Beck Depression Inventory score did not differ between treatment groups.
The investigators concluded that bilateral subthalamic stimulation in this population of patients with PD is relatively safe with respect to postoperative apathy, anxiety, and depression, provides a clear-cut improvement in disabling neuropsychiatric fluctuations, and permits easier long-term management of behavioral complications of dopamine replacement therapy compared with dopaminergic medications alone.
Lhommee E, Wojtecki L, Virginie Czernecki et al. Behavioural outcomes of subthalamic stimulation and medical therapy versus medical therapy alone for Parkinson’s disease with early motor complications (EARLYSTIM trial): secondary analysis of an oen-label randomized trial. Lancet Neurology. 2018;17:223231.