Objective: In this report, real-world outcomes using Directional Deep Brain Stimulation (DBS) Systems with multiple independent current source control (MICC) for use in managing symptoms of levodopa-­responsive Parkinson’s disease (PD) are reported.

Background: Older generation 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 potential to improve outcomes by avoiding off-target stimulation due to ability to create a well-defined field around the intended target. Several pilot studies have corroborated use of directionality and its impact on therapeutic window and adverse effects (1-3).

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: To date, 627 patients implanted with a directional DBS System have been evaluated. Improvement in quality of life as assessed by PDQ-39 (p < 0.001) up to 1-year demonstrated clinically significant improvement (minimal clinically important difference [MCID]: 4.7-points). Out to 2-years, improvement was sustained despite expected 5-point worsening due to disease progression. Improvements in motor function (change in MDS-UPDRS Ill scores meds­ off condition) versus baseline were also noted (31% at 1-year; n=200, p<0.001).

Conclusion: Directional DBS offers potential for expansion of the therapeutic window via improved targeting of relevant neural substrates while concurrently minimizing inadvertent, off-target stimulation that in turn can cause adverse effects. This on-going registry represents the first comprehensive, large scale collection of real-world outcomes using a directional lead and an MICC-based constant-current, multiple-source DBS system.

References: 1. Steigerwald F, MOiier L, Johannes S, et al. Directional deep brain stimulation of the subthalamic nucleus: A pilot study using a novel neurostimulation device. Mov Disord. 2016 Aug; 31(8): 1240-1243.
2. Dembek TA, Reker P, Visser-Vandewalle V, et al. Directional DBS increases side-effect thresholds-A prospective, double-blind trial. Mov Disord 2017 Oct;32(10):1380-1388.
3. Falconer R, Shah T, Rogers S, et al. Utilizing the Flexibility of Directional Deep Brain Stimulation lntraoperatively (if Needed) to Minimize Microelectrode Lead Repositioning. Cureus. 2019 Jul 30;11 (7):e5276.

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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-2/