Congratulations on your new publication!
Congratulations to Drs. Michael S. Okun and Kelly D. Foote on the publication of “Real-World Outcomes in Patients Implanted With DBS Systems Capable of Directionality and Multiple Independent Current Control,” which will appear in the April edition of Neurosurgery.
Introduction
Tracking those being treated for Parkinson’s disease (PD) motor symptoms offers insight regarding the outcomes associated with the implanted Deep Brain Stimulation (DBS) systems that are utilized by patients in the real-world clinical setting.
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.