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Subthalamic nucleus deep brain stimulation (DBS) is an FDA-approved therapy for controlling motor symptoms and fluctuations in Parkinson disease. To determine the safety and clinical efficacy of a novel multiple independent contact current-controlled (MICC) DBS system targeted to the subthalamic nucleus, investigators conducted a multicenter, double-blind, randomized, sham-controlled trial funded by the device manufacturer in patients with Parkinson disease.
Of the first 160 patients, 121 were randomly assigned to active stimulation and 39 to sham stimulation. At 3 months, a significant increase was observed with active stimulation versus sham stimulation in the primary outcome — the difference in mean change from baseline in the number of d…