Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control

Congratulations Drs. Michael Okun and Kelly Foote on the publication of “Real-World Outcomes in USA using DBS Systems with Directionality and Multiple Independent Current Control,” which was published in the April 25th edition of Neurology.



Objective: To characterize real-world data (USA experience) with the use of directional Deep Brain Stimulation (DBS) systems with multiple-independent current control (MICC) in the treatment of Parkinson’s Disease (PD).

Background: Randomized controlled trials have demonstrated that DBS can be an effective strategy for reducing the motor complications in PD (Okun 2012, Schuepbach, 2013, Vitek 2020) with potential for sustained improvement greater than 10-years (Deuschl 2013). However, large, multi-center, real-world data can reveal insights in the care of PD patients when DBS is used per standard-of-care.

Design/Methods: Prospectively enrolled participants are implanted with Vercise DBS systems (Boston Scientific), a multiple-source, constant-current system, and are assessed up to 3-years post-implantation. Clinical measures recorded at baseline and during study follow-up include MDS-Unified Parkinson’s disease Rating Scale (MDS-UPDRS), Parkinson’s Disease Questionnaire (PDQ-39), Global Impression of Change (GIC), and Non-Motor Symptom Assessment Scale (NMSS). Adverse events and device-related complications are also collected.

Results: A total of 106-patients (mean age: 63.8 ± 8.7 years, 73% male, disease duration 9.9-years) have been enrolled, and 82 have had their device activated. At 6-months (n = 56), an 8.3-point improvement in PDQ-39 Summary Index (27.1 à 18.8, p<0.0001) was noted, thereby representing a clinically significant improvement in quality of life (MCID >4.7-points) (Horvath 2017). According to GIC, all patients (100%) and 95% of clinicians reported improvement at 6-months. No lead breakage or unanticipated adverse events reported.

Conclusions: Real-world outcomes from this large, prospective, multi-center outcomes study demonstrate improvement in quality of life following DBS, and a high global impression of improvement among patients and clinicians. Data from this study will continue to provide insight regarding the application of the MICC-based directional DBS Systems for PD in clinical practice.