Congratulations to Drs. Michael Okun and Kelly Foote on the publication of ” Real-World Outcomes Using DBS Systems With Directionality and Multiple Independent Current Control: USA Experience.” which appears in the October Supplement of Neuromodulation: Technology at the Neural Interface.
Abstract
Introduction
Deep Brain Stimulation (DBS) is an effective strategy for reducing the motor complications in Parkinson’s disease (PD) and outcomes have been confirmed by multiple randomized controlled clinical trials.1-3 This motor improvement has been shown to be sustained for up to 10 years.4 Clinical data collected from a wide variety of implanting centers (based on standard of care) documenting the overall improvements in PD disease symptoms and quality-of-life will likely facilitate new insights regarding the real-world, clinical use and outcomes of DBS. Here, we present preliminary outcomes from an ongoing prospective, multicenter outcomes study conducted in the United States consisting of patients implanted with directional DBS Systems capable of multiple independent current control (MICC) for use in the management of the motor signs and symptoms in levodoparesponsive PD.
Methods
Prospectively-enrolled participants were implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant- current system, and were assessed up to 3-years post-implantation. Clinical measures recorded at baseline and during the follow-up included MOS-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
A total of 111-subjects (mean age: 64.1 ± 8.7 years, 73% male, disease duration 9.7 ± 5.3 years, n = 108) have been enrolled to date, and 93 of these have undergone device activation. A 56.4% improvement (28.2-points, p<0.0001) in motor function was noted at 6-months as assessed by the MDS-UPDRS III in the “off” medication condition. Quality of life was also significantly improved as noted by an 8.4-point improvement in the PDQ-39 Summary Index (p<0.0001). Notably, the denoted clinical significance or minimal clinically important difference (MCID) for PDQ-39 were reported previously as 4.7-points.5 At 6-months, 98% of patients and 95% of clinicians reported improvement (GIC). To date, no lead fractures or unanticipated adverse events were reported. We will present the most up to data at the meeting.
Conclusion
Real-world outcomes from this large, prospective, multicenter outcomes study demonstrated improvement in quality-of-life and motor function following DBS. The study also documents the overall satisfaction among patients and clinicians. Data from this study will continue to provide insight regarding the application of the MICCbased directional DBS Systems for PD as applied in real world settings.