Introduction: The effectiveness of Deep Brain Stimulation (DBS) for reducing motor complications of Parkinson's disease (PD) has been substantiated by randomized controlled trials (Schuepbach et al.,2013). Additionally, motor improvement is sustained for up to 10 years (Deuschl et al. 2013). Large patient data registries may facilitate insights regarding real world, clinical use of DBS. Furthermore, no registry database currently exists for a multiple-source, constant current DBS system. The objective this report is to describe collected outcomes from a large scale registry of a Deep Brain Stimulation (DBS) system capable of Multiple Independent Current Source Control (MICC) in the management of 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 Corporation. The Vercise DBS system (Boston Scientific) is a multiple-source, constant-current system. 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 included Unified Parkinson's disease Rating Scale (UPDRS), MDS-UPDRS, Parkinson's disease Questionnaire (PDQ-39), and Global Impression of Change.
Results: To date, 290 patients have been enrolled in the registry and this report will provide an overview of the data collected so far from implanted patients within this cohort. At 1 year post-implant, 36.2% improvement in MDS-UPDRS III scores (stim on/meds off) compared with baseline was reported. This improvement in motor function was supported by an improvement in quality of life as assessed by PDQ39 Summary Index (5.6 point improvement, n =146) at 1 year. Roughly 90% of patients and clinicians reported improvement as compared with Baseline.
Conclusions: This DBS registry represents the first comprehensive, large scale collection of real-world outcomes and evaluation of safety and effectiveness of a multiple-source, constant-current DBS system.
Patient Care: Fractionalization of stimulation current using a multiple-source mode of delivery (MICC) allows for the utilization of a well-defined, shaped electrical field. This may help to improve the magnitude and reliability of the motor response, while reducing stimulation related side-effects.
Learning Objectives: By the conclusion of this session, participants will be informed of the real-world outcomes from this large scale registry of a Deep Brain Stimulation (DBS) System capable of multiple independent current source control (MICC) in the management of symptoms of levodopa-responsive Parkinson's disease (PD).
References: 1) Schuepbach WM., et al. N Engl J Med. 2013 Feb 14;368(7):610-22.
2) Deuschl G. and Agid Y. Lancet Neurol. 2013 Oct;12(10):1025-34