Objective: To evaluate clinical outcomes in subjects implanted with a Directional Lead for use in the treatment of levodopa-responsive Parkinson’s disease (PD) as part of an on-going Registry.

Background: Deep Brain Stimulation (DBS) systems have traditionally used ring-shaped electrodes that produce a spherical stimulation field which can only be varied in intensity, thereby limiting the extent of volume of tissue activated. A pilot study of 7 PD subjects reported that a novel, directional permanently implanted DBS system, combining an eight-contact directional lead and an implantable pulse generator (IPG) capable of multiple independent current control (MICC), can accomplish directional current steering (Steigerwald F. et al., Mov Disord, 2016). 

Methods: The Vercise DBS Registry is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. The Vercise PC system (Boston Scientific) is a CE-marked, multiple-source constant current system with a non-rechargeable battery. Subjects will be followed up out to 3 years post-implantation. Clinical endpoints will be evaluated at baseline and during study follow up that include 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. Subjects in this specific cohort were implanted with a directional lead included as part of a directional DBS system for bilateral STN-DBS. 

Results: Subjects from several European centers and implanted with a directional lead as part of an on-going Registry study will be evaluated. Preliminary data suggests an overall improvement in quality of life as assessed by PDQ-39. As of January 1^st, 2017, a total of 60 patients have been implanted with the directional lead. Baseline data for this cohort as well follow up data at 6 months (n = 50) and 12 months (n = 20) post-implant as available will be presented. Preliminary analysis shows improvement of quality of life comparable to conventional leads. 

Conclusions: Data from this specific cohort will provide insight on the use of current steering with a directional lead as part of the directional DBS system, and its implications in the treatment of patients.

References: Steigerwald F. et al. Mov Disord. 2016 Aug;31(8):1240-3.

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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-dbs-for-parkinsons-disease/