Congratulations to Drs. Michael Okun and Kelly Foote!
Drs. Michael Okun and Kelly Foote recently published “ID# 1884679 Clinical Outcomes Using DBS Systems with Directionality and Multiple Independent Current Control: Real-World, USA Experience,” which appears in the October issue of Neuromodulation: Technology at the Neural Interface.
Abstract
Introduction
Deep Brain Stimulation (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 additional insights regarding real-world, clinical use and outcomes of DBS. Here, we present preliminary outcomes from an ongoing perspective, multicenter outcomes registry conducted at centers in the United States consisting of patients implanted with directional DBS systems capable of multiple independent current control (MICC) for use in management of the motor signs and symptoms in levodopa-responsive PD.
Methods
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.