What this Trial Is About

Researchers are evaluating the effectiveness of deep brain stimulation (DBS) in two different brain areas—the posterior subthalamic area (PSA) and the subthalamic nucleus (STN)—to treat dystonic tremor (DT). This study is a randomized, double-blinded, crossover trial designed to compare how well DBS works when targeting these two regions in patients with DT. Patients enrolled in the study have had motor symptoms of dystonic tremor for at least 3 years and meet specific diagnostic criteria. Participants will undergo bilateral DBS surgery where both the PSA and STN are targeted using a single trajectory. Three months after implantation, patients enter a 4-month double-blinded crossover phase where stimulation is alternated between PSA and STN in a randomized order. After 7 months post-implantation and completion of the crossover phase, patients enter an open-label phase where DBS programming is unrestricted until the study ends at a 12-month follow-up. During the study, researchers will assess changes in tremor severity using the Fahn-Tolosa-Marin Clinical Rating Scale for Tremor at 5 and 7 months. Patients will be monitored through clinical evaluations and DBS programming adjustments throughout the trial. The study focuses on safety and effectiveness, with follow-up continuing up to one year after surgery to gather comprehensive data on treatment impact.

PSA Versus STN DBS for DT