Objective: Here, we present preliminary outcomes from an on-going, prospective, multicenter outcomes registry conducted in the USA consisting of patients implanted with directional Deep Brain Stimulation (DBS) systems capable of multiple independent current control (MICC) for use in management of motor signs and symptoms in levodopa-responsive Parkinson’s disease (PD).

Background: DBS is an effective strategy for reducing Parkinson’s Disease (PD) motor complications. Data collected from a wide variety of implanting centers (based on standard of care) treating PD patients may help provide addtional insights regarding real-world, clinical use and outcomes of DBS.

Method: Prospectively-enrolled participants were implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant-current system, and assessed up to 3-years post-implantation as part of an on-going DBS patient outcomes registry (clinicaltrials.gov identifier: NCT02071134). Clinical measures recorded at baseline and during follow-up included MDS-Unified Parkinson’s disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Questionnaire (PDQ-39), Global Impression of Change (GIC), and the Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications were also collected.

Results: To date, a total of 141-subjects (mean age: 64.0±9.0 years, 71.5% male, disease duration 9.4±5.1 years, n=137) have been enrolled, and 116 of these have undergone device activation. A 53.4% improvement (27-points, p<0.0001) in motor function was noted at 6-months as assessed by the MDS-UPDRS Ill in the “off” medication condition. At 6-months follow-up, over 95% of subjects and over 90% of clinicians noted improvement (GIC) as compared with Baseline. Improvements in various quality life measures (PDQ-39) were seen in the following: mobility, activities of daily living, bodily discomfort, emotional well-being, and stigma. To date, no lead fractures or unanticipated adverse events were reported. Additional results derived from on-going data collection will be presented.

Conclusion: Real-world outcomes from this large, prospective, multicenter outcomes registry demonstrated improvement in motor function, quality-of-life, and satisfaction following DBS. This on-going registry will continue to provide insight regarding application of MICC-based directional DBS Systems for PD as applied in real-world settings.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/clinical-and-safety-outcomes-using-dbs-systems-with-directionality-and-multiple-independent-current-control-real-world-usa-experience/