Objective: To investigate the effectiveness and safety-related real-world outcomes of a multiple-source, constant current Deep Brain Stimulation (DBS) System in the treatment of levodopa-responsive Parkinson’s disease (PD) collected as part of a large scale registry. Additionally, this registry utilizes the newly developed MDS-UPDRS for the evaluation of motor symptoms and includes the evaluation of non-motor symptoms of PD (Non-Motor Symptom Assessment Scale) following DBS.

Background: The effectiveness and safety of the use of DBS to reduce motor complications of PD patients has been substantiated by several randomized controlled trials (Schuepbach WM. et al., 2013). Motor improvement following DBS is sustained for up to 10 years as reported by Deuschl G. and Agid Y., 2013. An in-depth evaluation of real world outcomes following DBS will add to the existing database of knowledge and be a useful tool for physicians.

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 CE-marked, multiple-source, constant current system with a rechargeable battery. Subjects will be followed up at 6 and 12 months and up to 3 years post-implantation where their overall improvement in quality of life and PD motor symptoms will be evaluated. 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.

Results: Preliminary data suggests an overall improvement in Quality of Life at 6 months post-implant as compared with Baseline as measured by a 17.6% (n = 89) improvement in PDQ-39 Summary Index. Over 90% of patients, caregivers and clinicians reported improvement as compared with Baseline. This report will provide the safety and effectiveness outcomes of the first cohort of subjects analyzed at 6 (N=150) and 12 months (N=100) post-implantation as compared with baseline.

Conclusions: The Vercise DBS registry represents the first comprehensive, large scale collection of real-world outcomes and includes evaluation of the safety and effectiveness of the Vercise DBS System up to 12 months post lead placement. 

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.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/outcomes-of-a-prospective-multicenter-international-registry-of-deep-brain-stimulation-for-parkinsons-disease/