Objective: In this report, initial real-world outcomes using a directional lead with a deep brain stimulation (DBS) system capable of multiple independent current source control (MICC) for use in managing symptoms of levodopa-responsive Parkinson’s disease (PD) are reported.

Background: Deep brain stimulation (DBS) systems have historically used ring-shaped electrodes that produce stimulation fields with limited control over field shape and volume of tissue activated. Directional current steering may permit a more personalized DBS approach with respect to individualized shape and pattern of electrical field and corresponding volume of tissue activated.

Method: The Vercise DBS Registry (ClinicalTrials.gov Identifier: 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 March 2019, 283 enrolled patients have been implanted with the directional lead. Change in PDQ-39 Summary Index demonstrated improvement in Quality of Life following DBS implant with the directional lead out to 6- (n=120) and 12-months (n=129) post-implant, respectively (p<0.001). Several sub-domains such as Activities of Daily Living, Bodily discomfort showed sustained improvement at 1-year post-implant (p<0.0001). Improvements in motor function (change in MDS-UPDRS III scores-meds off condition) was observed at 6- and 12-months post-implant. Additional data is to be presented.

Conclusion: Enabling fractionalization of current using MICC can permit application of a well-defined, shaped, electrical field. This on-going registry represents the first comprehensive, large scale collection of real-world outcomes using a directional lead and an MICC-based DBS system.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/real-world-clinical-outcomes-using-a-novel-directional-lead-from-a-multicenter-registry-of-deep-brain-stimulation-for-parkinsons-disease-2/