Deep Brain Stimulation (DBS) has been substantiated by several randomized controlled trials as an effective strategy for reducing the motor complications in Parkinson's disease (PD).1-3 This motor improvement has been shown in cohorts to possibly be sustained for up to 10 years.4 Clinical data collected from a wide variety of implanting centers using local standard of care has revealed overall improvements in PD disease symptoms and quality-of-life when applying DBS therapy. Here, we present preliminary outcomes from an ongoing, prospective, multicenter study conducted in the United States 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 of levodopa- responsive PD.
Prospectively-enrolled participants were implanted with a DBS system (VerciseTM, Boston Scientific, Valencia, CA, USA), a multiple-source, constant- current device, and were assessed up to 3-years post-implantation. Clinical measures recorded at baseline and during study follow-up included: 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), and adverse events.
A total of 111-patients (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 have devices which have been activated. A 56.4% improvement (28.2-points, p<0.0001) in motor function was noted at 6-months as assessed by MDS-UPDRS III in the meds "off" stimulation “on” condition. Quality of life was improved with an 8.4-point change in the PDQ-39 Summary Index (p<0.0001). This change exceeded the minimal clinically important difference (MCID) for PDQ-39 which is 4.7-points.5 At 6-months post-DBS, a categorical subject measure revealed that 98% of patients and 95% of clinicians reported improvements (GIC). There have been no lead breakages.
In this study, collection of real-world data across multiple implanting centers is informing on longer-term outcomes of MICC-based DBS systems.
Real-world outcomes from this large, prospective, multicenter outcomes study demonstrate improvement in quality-of-life and motor function following DBS, and overall satisfaction 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.
1. Okun MS, Gallo BV, Mandybur G, et al. Subthalamic deep brain stimulation with a constant-current device in Parkinson's disease: an open-label randomised controlled trial. Lancet Neurol. 2012 Feb;11(2):140-9.
2. Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013 Feb 14;368(7):610-22.
3. Vitek JL, Jain R, Chen L, Tröster AI, et al. Subthalamic nucleus deep brain stimulation with a multiple independent constant current-controlled device in Parkinson's disease (INTREPID): a multicentre, double-blind, randomised, sham-controlled study. Lancet Neurol. 2020 Jun;19(6):491-501.
4. Deuschl G, Paschen S, Witt K. Clinical outcome of deep brain stimulation for Parkinson's disease. Handb Clin Neurol. 2013;116:107-28.
5. Horváth K, Aschermann Z, Kovács M, et al. Changes in Quality of Life in Parkinson's Disease: How Large Must They Be to Be Relevant? Neuroepidemiology. 2017;48(1-2):1-8.
1. To assess real-world motor function outcomes when utilizing MICC-based DBS systems with directionality in patients with Parkinson’s Disease.
2. To assess real-world safety when utilizing MICC-based DBS systems with directionality on patients with Parkinson’s Disease.
3. To assess real-world quality-of-life outcomes when utilizing MICC-based DBS systems with directionality on patients with Parkinson’s Disease.