Introduction: The use of Deep Brain Stimulation (DBS) to reduce motor complications of PD patients has been substantiated by several randomized controlled trials (Schuepbach et al., 2013) and shown to be sustained for up to 10 years (Deuschl et al. 2013). However, no registry database currently exists for a multiple-source, constant current DBS system. As part of an on-going, large scale registry study, we investigated the effectiveness and safety-related real-world outcomes of a multiple independent current source control (MICC) Deep Brain Stimulation (DBS) System for use in the management of motor symptoms of levodopa-responsive Parkinson’s disease (PD).
Methods: The is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. Patients are implanted with a CE-marked, MICC-based DBS system (Vercise, Boston Scientific). 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: This registry represents the first comprehensive, large scale collection of real-world outcomes and includes evaluation of the safety and effectiveness of an MICC-based DBS System up to 12 months post lead placement.
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 further improve the magnitude and reliability of the motor response, while reducing stimulation-related side-effects.
Learning Objectives: By the conclusion of this session, participants should be able to:
1) understand and communicate the potential advantage(s) of an MICC-based DBS system for management of PD motor symptoms.
2) have a reasonable expectation regarding how an MICC-based DBS system performs in the real world clinical setting.
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.