Anatomically vs. eLectrophysIologically Guided Contact SelectioN in Deep Brain Stimulation for Parkinson’s Disease (ALIGN-PD): Study Protocol for a Randomized Double-blind Crossover Trial

Abstract Background Parkinson’s disease (PD) motor symptoms are effectively treated with subthalamic deep brain stimulation (STN-DBS). LFP guided, adaptive deep brain stimulation (LFP-adaptive-DBS) is a novel strategy which adjusts stimulation current based on measured neuronal activity. This trial is the first to compare anatomically informed continuous DBS (Anatomy-continuous-DBS) to LFP-adaptive-DBS. Methods We conduct a monocentric, randomized and double-blind crossover trial with 30 PD patients enrolled. Patients receive two different programs (Anatomy-continuous-DBS and LFP-adaptive-DBS), each program is tested for two weeks after an initial optimization phase. In the LFP-adaptive-DBS program, the contact selection is based on LFP measurements, while contact selection in the Anatomy-continuous-DBS program is based on individual anatomy targeting the dorsolateral STN. The primary outcome is patient preference after completion of both phases. Secondary outcomes comprise motor symptoms, electrophysiological assessments, accelerometric monitoring and questionnaire-based measurements of non-motor symptoms, treatment expectation, and quality of life. Discussion To date both approaches have not been evaluated in a head-to-head comparison, and it remains unclear whether any offers superior treatment effects. This trial aims to provide insights into clinical utility of LFP-adaptive-DBS in comparison to anatomy-informed continuous DBS. We hope to provide further insights into the question which patients might benefit most from LFP-adaptive-DBS. Trial registration https//drks.de/register/de/trial/DRKS00037920/preview Number DRKS00037920, Date 20250916