Objective: To evaluate changes in therapeutic window values for changes in directional Deep Brain Stimulation (DBS) stimulation.

Background: Historically, DBS systems have delivered stimulation using cylindrical electrodes, which may stimulate neurons around the entire circumference of the lead. In this study, we test a directional DBS lead, which adds radially segmented electrodes designed for selective stimulation in directions orthogonal to the lead trajectory. One way to show clinical proof of the additional capabilities of directional leads is to examine the therapeutic windows of varying directional stimulation settings.

Methods: DIRECT-DBS is a prospective, randomized, multi-center, double-blind study employing a crossover design. A total of 12 subjects have been 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: during implant, at 3-5 months, and at 1 year. At 3 months, multiple single-day programming visits will be undertaken to optimize directional programming, based on observed clinical responses. In one of the visits, various directional stimulation settings are explored at the optimal longitudinal level, first in 90 degree increments, then in 30 degree increments. These fine explorations require precise fractionalization of the current between sets of segmented electrodes. At each of these settings, the therapeutic window is calculated as the difference between the minimum amplitude which gives full rigidity control and the minimum amplitude that elicits a limiting side effect.

Results: Examination of the results collected thus far show differences in therapeutic windows at the various directional stimulation settings. These differences can manifest in changes as small as 30 degrees in the rotational direction.

Conclusions: These results show that directional stimulation is a useful advancement in DBS technology as it may enable the user to elicit differential clinical responses which may not have been observed with other programming changes.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/direct-dbs-a-prospective-multicenter-clinical-study-with-double-blinding-for-a-directional-deep-brain-stimulation-lead-therapeutic-windows-with-directional-stimulation/