Objective: To report real-world, long-term outcomes using a Directional DBS System with multiple independent current source control (MICC) for use in managing symptoms of levodopa-responsive Parkinson’s disease (PD).

Background: Early Deep Brain Stimulation (DBS) systems used ring-shaped electrodes to achieve axial selectivity in stimulation of target tissue. However, directional current steering allows for rotational selectivity (in addition to axial) and has the potential to further improve patient outcomes by avoiding off-target stimulation due to the ability to create a well-defined field around the intended target. Several pilot studies have corroborated the use of directionality and its impact on therapeutic window and adverse effects.

Method: The Vercise DBS Registry (NCT02071134) is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific. Subjects were implanted with a directional lead included as part of a multiple-source, constant-current directional DBS system (Vercise Cartesia, Boston Scientific). Subjects were followed up to 3-years post-implantation where their overall improvement in quality of life and PD motor symptoms was evaluated. Clinical endpoints evaluated at baseline and during study follow-up included Unified Parkinson’s disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson’s disease Questionnaire (PDQ-39), and Global Impression of Change.

Results: As of February 2021, 627 patients (mean age: 60.9 years, 68.4% male) included were implanted with a DBS directional lead. Improved Quality of Life, as assessed by PDQ-39 (p<0.001) following implant was noted up to 1-year post-implant (n=368). Improvements in motor function (change in MDS-UPDRS III scores-meds off condition) versus baseline were also noted (31% at 1-year (n=200), p<0.001). Over 80% of subjects, physicians reported an improvement in PD symptoms during long-term follow-up.  Additional data collection and analysis is ongoing and will be presented.

Conclusion: This on-going registry represents the first comprehensive, large scale collection of real-world, long-term outcomes using a directional lead and an MICC-based DBS system. Using directional stimulation, it may be possible to achieve a bigger therapeutic window, thereby facilitating enhanced programming flexibility when optimizing for efficacy, while decreasing the likelihood of surpassing the adverse effect threshold.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-outcomes-using-a-novel-directional-lead-from-a-multicenter-dbs-registry-for-parkinsons-disease/