Congratulations to Drs. Michael Okun and Kelly Foote on the publication of “Long-term Outcomes in Patients Implanted with DBS Systems Capable of Directionality and Multiple Independent Current Control (P2-5.024),” which appears in the April issue of Neurology.
Abstract
Objective:
This on-going registry seeks to collect/analyze real-world clinical outcomes out to 2-years follow-up in levodopa-responsive Parkinson’s disease (PD) patients implanted with DBS systems equipped with Multiple Independent Current Control (MICC) and Directionality.
Background:
Tracking those being treated for PD motor symptoms offers insight regarding the outcomes associated with the implanted DBS systems that are utilized by patients in the real-world clinical setting.
Design/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 MOS-Unified Parkinson’s disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Questionnaire (PDQ-39), Global Impression of Change (GI(), and the Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications are also collected.
Results:
Enrollment and device activation consists of 174-subjects (mean age: 64.2 ± 8.7 years, 68.5% male, disease duration 9.3 ± 5.1 years, n = 168) and 142-subjects, respectively. Assessment of MDS-UPDRS Ill in “off” medication condition demonstrated a 51% improvement (25-points, p<0.0001) in motor function at 6-months. This level of motor function improvement was maintained out to 1-year (22-point improvement) and to 2-years (24-point improvement) follow-up. As compared with baseline, over 93% of patients and over 89% of clinicians noted improvement (GIC) at 6-, 12-, and 24-months follow-up. Outcomes were improved in various quality life measures (PDQ-39): 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.
Conclusions:
Following DBS, outcomes derived from this on-going multicenter, prospective registry demonstrated improved motor function, quality-of-life, and satisfaction. 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.