Objective: To visualize the volumes of activated tissue in relation to the neuroanatomy for the optimal stimulation parameters in Ring Mode (omnidirectional) stimulation in comparison to directional stimulation.

Background: Historically, Deep Brain Stimulation (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. This technology, combined with the ability to use imaging to create a patient-specific visualization of their neuroanatomy and lead location, can help us understand the optimal anatomical target for DBS.

Methods: DIRECT-DBS is a prospective, randomized, multi-center, double-blind study employing a crossover design. A total of 12 subjects with advanced Parkinson’s disease (PD) were 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. The electrodes were implanted with the directional marker facing anterior and subsequent analysis was based on the assumption that it remain in this orientation. At 3 months, multiple single-day programming visits were undertaken based on observed clinical responses. The first visit required the clinician to identify the optimal Ring Mode stimulation location in a blinded, randomized fashion. The second visit had the clinician identify the optimal directional stimulation location, again in a blinded, randomized fashion. We can compare the optimal Ring Mode stimulation volume to the optimal directional stimulation volume.

Results: Examination of the results collected thus far shows a tendency for the optimal directional stimulation to direct the volume of activated tissue towards the dorsolateral portion of the Subthalamic Nucleus (STN).

Conclusions: As the optimal directional stimulation was identified in a blinded, randomized fashion and based solely on the observed clinical responses, this result is a confirmation of the prevailing assumption of the dorsolateral STN as the ideal anatomical target for DBS for PD patients.

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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-visualization-of-optimal-directionally-stimulated-anatomy/