Comparing Directional Deep Brain Stimulation of Posterior Subthalamic Area and Subthalamic Nucleus for Tremor-Dominant Parkinsons Disease in a Randomized Double-Blind Crossover Trial

What this Trial Is About

Researchers are comparing two types of directional deep brain stimulation DBS targeting different brain areasthe posterior subthalamic area PSA and the subthalamic nucleus STNto treat tremor-dominant Parkinsons disease PD. The study is designed as a randomized, double-blinded, crossover trial to evaluate which stimulation site may better control tremors and improve motor symptoms. The goal is to assess the clinical effectiveness and tolerability of these DBS approaches in the same patients. Participants undergo a two-phase study. In Phase 1, two months after DBS implant surgery, acute testing is done in a randomized and blinded order to find the best stimulation settings for both PSA and STN. If a stimulation site causes intolerable side effects, it is excluded from the next phase. In Phase 2, participants receive chronic stimulation in a randomized crossover design, with two months of stimulation at one site followed by two months at the other. After this, eligible patients enter an open-label phase where combined stimulation of both PSA and STN is tested for two months. Follow-up continues for up to 12 months after surgery. Throughout the study, participants are assessed with clinical rating scales measuring tremor severity, balance, and overall Parkinsons symptoms at baseline and at the end of each stimulation period. Researchers monitor for adverse effects and intolerance to stimulation during both acute and chronic phases. The main outcome is the change in tremor scores between PSA and STN stimulation. The study involves detailed clinical evaluations and safety monitoring to understand the benefits and risks of these directional DBS treatments.

Directional PSA Versus STN DBS for TD-PD