Abstract
The efficacy of deep brain stimulation (DBS) for Parkinson's disease (PD) depends on optimizing stimulation parameters for each patient, a time-sensitive process. Image-guided programming (IGP) offers a promising method to streamline this.
The objective was to evaluate the real-world effectiveness of an IGP tool with directional leads during the initial programming of bilateral subthalamic nucleus (STN) or globus pallidus internus (GPi) DBS in PD patients.
A total of 57 PD patients (46 bilateral STN, 11 bilateral GPi) from the Vercise DBS Registry (NCT#02071134) were enrolled into the GUIDE XT substudy. Time for initial programming using IGP, Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III at baseline, 6-months, and 1-year postactivation, Global Impression of Change from patients and clinicians, and the continued use of IGP-suggested settings were analyzed. Stimulation field model (SFM) overlap between initial and 1-year target volumes was also examined.
Motor function significantly improved at 6 months and 1 year (55% and 45%, P < 0.0001) compared to baseline, as assessed by MDS-UPDRS III (Meds OFF/Stim ON). Initial programming sessions of bilateral leads using IGP (n = 56) lasted 39.4 ± 4.4 minutes (mean ± standard error [SE]), whereas it was completed in less than 30 minutes in 55% of subjects. Contact selection, polarity, and fractionalization determined at initial programing using IGP remained unchanged in 52% and 43% of subjects (n = 21) up to 6 months and 1 year, respectively. The average SFM overlap for all subjects was 92% (SE: 15%) at the 1-year visit.
IGP facilitates efficient initial programming sessions, providing stable settings that result in long-term motor improvements.