Objective: To describe collected outcomes from a large-scale registry of a Deep Brain Stimulation (DBS) system capable of Multiple Independent Current Source Control (MICC) used for the management of symptoms of levodopa-responsive Parkinson’s disease (PD).

Background: The effectiveness of DBS for reducing motor complications of PD has been substantiated by randomized controlled trials (Schuepbach 2013). Additionally, motor improvement can be sustained for up to 10 years (Deuschl et al. 2013). Large patient data registries may facilitate insights regarding real world, clinical use of DBS. However, no registry database currently exists for a multiple-source, constant current DBS system.

Method: The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) 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 out 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. The Vercise DBS Registry (ClinicalTrials.gov Identifier: NCT02071134) 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 out 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, 403 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 2-years post-implant, the PDQ-39 Summary Index, EQ-5D-5L, and Schwab and England (SE) scores all demonstrated an improvement in Quality of Life (n=131). In addition, over 80% of subjects, caregivers, and clinicians reported a sustained improvement in PD symptoms out to 2-years post-implant as measured by Global Impression of Change. Updated data, including overall safety profile, will be presented.

Conclusion: 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.

References: Schuepbach WM., et al. N Engl J Med. 2013 Feb 14;368(7):610-22. Deuschl G., et al. Handb Clin Neurol. 2013;116:107-28.

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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-2/