DIRECT DBS: A Prospective, Multi-center Clinical Study with Blinding for a Directional Deep Brain Stimulation (DBS) Lead (P4.068)

Objective: To characterize effects in subjects with Parkinson’s disease implanted with a directional Deep Brain Stimulation (DBS) system with leads targeting the Subthalamic Nucleus that include radially segmented electrodes designed for selective stimulation in directions orthogonal to the lead trajectory in addition to standard cylindrical electrodes. Background: Historically, DBS systems have delivered stimulation using leads with cylindrical electrodes, which may stimulate neurons around the circumference of the lead. The directional DBS system investigated in this study is capable of current steering to shape stimulation in the plane orthogonal to the long axis of the lead (directional stimulation), as well as providing Ring Mode (omnidirectional) stimulation equivalent to historical leads. Design/Methods: DIRECT-DBS is a prospective, randomized, multi-center, double-blind study employing a crossover design. Up to a total of 12 subjects will be enrolled and implanted per standard of care with bilateral directional DBS leads (Vercise Cartesia, Boston Scientific) connected to a pulse generator providing an independent current source for each of 16 contacts. Visits occur in 3 major periods: implant visit, 3–5 months visits, and 1 year visit. Programming is restricted during the first 3 months post-implant to Ring Mode. At 3 months, multiple single-day programming visits will be undertaken to optimize directional programming. Patients are then randomized to one of two arms (4 weeks per arm) for a double-blind crossover comparison between Ring Mode and unrestricted (e.g. directional) programming. After the crossover phase, subjects enter an open-label phase, with follow-up at 1 year. Results: This evaluation has no prospective statistical hypothesis, but collects data such as therapeutic thresholds, side effect thresholds, therapeutic window, UPDRS-III, PDQ-39, and quantitative accelerometer-based measures of bradykinesia and tremor. The preliminary data obtained so far will be reported. Conclusions: Preliminary results so far show differences in the clinical responses related to different directional stimulation. Results will inform future studies. Study Supported by: Boston Scientific Disclosure: Dr. Steigerwald has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific, St. Jude Medical. Dr. Steigerwald has received research support from Boston Scientific and Medtronic. Dr. Volkmann has nothing to disclose. Dr. Matthies has nothing to disclose. Dr. Kirsch has nothing to disclose. Dr. Chabardes has nothing to disclose. Dr. De Bie has nothing to disclose. Dr. Schuurman has nothing to disclose. Dr. Moro has nothing to disclose. Dr. Fraix has nothing to disclose. Dr. Meoni has nothing to disclose. Dr. Blum has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Juarez Paz has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Wynants has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific. Dr. Van Dyck has received personal compensation for consulting, serving on a scientific advisory board, speaking, or other activities with Boston Scientific.