Objective: The objective of this report is to assess the 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).

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. Here we report initial real-world outcomes using a directional lead with a DBS system capable of multiple independent current source control (MICC) for use in managing symptoms of levodopa-responsive Parkinson’s disease (PD).

Methods: The Vercise DBS Registry is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific. Subjects in this cohort 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. Adverse events are also collected.

Results: A total of over 100 subjects have been enrolled in this specific cohort. A 6.1 ± 12.11 (n = 73) point improvement was noted in the PDQ-39 Summary Index at the 6-month interval compared with Baseline and this improvement continued up to 1 year post-implant. Subjects, clinicians, and caregivers reported over 90% improvement in the symptoms at 6 months post-lead implant as compared with Baseline and this was maintained up to the 12-month interval. Additional data is to be presented.

Conclusions: Enabling fractionalization of current using MICC can permit the application of a well-defined, shaped, electrical field. Use of a directional lead allows for the steering of current in horizontal directions by combining segmented leads and MICC.

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