Objective: To report the outcomes of an ongoing prospective, international, large-scale registry of Deep Brain Stimulation (DBS) systems for Parkinson’s Disease.

Background: Several studies have demonstrated the use of high-frequency Deep Brain Stimulation (DBS) to be effective in reducing the motor complications of Parkinson’s Disease (PD) that are not adequately controlled with medication and improved quality of life. Motor improvement following DBS has been shown to be sustained for up to 10 years. Large patient data registries can help facilitate new insights regarding real world, clinical use of DBS.

Method: The Vercise DBS Registry is a prospective, on-label, multi-center, international registry sponsored by Boston Scientific Corporation. The family of Vercise DBS systems (Boston Scientific) are comprised of primary cell/rechargeable implantable stimulators and DBS leads (including directional leads) designed to precisely deliver a well-defined distribution of current to target location (multiple-source, constant-current systems). Enrolled subjects are followed up to 3-years post-implantation and overall improvement in quality of life (PDQ-39), motor function (UPDRS/MDS-UPDRS), non-motor symptoms (NMSS) and overall satisfaction are evaluated. Adverse events are also collected.

Results: To date, 822 patients have been enrolled (752 implanted). Improvement in quality of life (QoL), as assessed by PDQ-39, demonstrated improvement following implant at 6-months (-6.1-point change, p<0.0001) and up to 2-years (-2.4-point change) as compared with Baseline. Higher improvement in QoL (-15.7-point change) was noted in patients with worse QoL at Baseline (PDQ-39 SI >45). This trend was also noted in subjects with worse disease state at Baseline (Hoehn & Yahr ≥ 3) who reported a greater improvement in PDQ-39 summary index.  At 1-year post-implant (n=272), a 32% improvement in MDS-UPDRS III scores (stim on/meds off) compared with baseline was reported and sustained up to 2-years (n=51). Stable neuropsychometric status (BDI-II, MoCA) was also reported. The safety profile was comparable to other published reports. Additional data collection and analysis is ongoing and will be presented.

Conclusion: This registry represents the first comprehensive, large-scale collection of long-term real-world outcomes on the basis of an evaluation of safety and effectiveness of a multiple-source, constant-current DBS system.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/long-term-motor-function-and-quality-of-life-outcomes-from-a-prospective-international-dbs-registry/