Introduction: 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.
Patient Care: 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.
Learning Objectives: By the conclusion of this session, participants should be able to: 1) evaluate preliminary clinical outcomes in subjects implanted with a directional Lead 2) obtain insight regarding the potential advantage(s) of current steering using a directional lead as part of a directional DBS system.
References: Steigerwald F. et al. Mov Disord. 2016 Aug;31(8):1240-3.