DBS with constant current from multiple sources improves quality of life in Parkinson’s disease, real-world analysis suggests

Preliminary results from a real-world study of more than 600 Parkinson’s disease (PD) patients showed that use of the Vercise deep brain stimulation (DBS) system (Boston Scientific) with multiple independent current source control (MICC) improved quality of life.¹

The data, presented at the 2022 International Parkinson and Movement Disorders Society Congress in Madrid, Spain, September 15-18, represented the first comprehensive, large-scale collection of real-world outcomes using directed leadership and a MICC-based DBS system. Overall, quality of life as assessed by the Parkinson’s Questionnaire (PDQ-39) improved after 1 year with the DBS system (P <.0001).

Coordinating investigator Gunther Deuschl, MD, Department of Neurology, University Hospital Zurich, and colleagues reported real-world results in 627 patients with Parkinson’s who were previously implanted with a directional DBS system. Subjects in the study had a disease duration of 10.3 years (SD 4.61) at baseline and were followed up to 3 years after implantation. The cohort consisted primarily of males (68.1%) and had a baseline PDQ-39 score of 28.5 overall.

Over the 2-year follow-up, the expected PDQ-39 scores would have reached 33.5 and 38.5 at 1-year and 2-year time points for those showing natural progression without DBS. Instead, DBS-treated subjects saw PDQ-39 scores of 24.2 at 1 year (n=613) and 26.1 at 2 years (n=375). Improvements observed at 1 year were considered clinically significant, while improvements at 2 years were considered sustained despite an expected 5-point worsening due to disease progression.

At baseline, the cohort showed mean MDS-Unified Parkinson’s Disease Rating Scale (UPDRS)-III scores of 46.4. After DBS implantation, patients demonstrated MDS-UPDRS-III total scores of 29.2 at 1 year, or 31%, which were maintained up to 2 years post-implantation, indicated by scores of 27.8, a change of 35 % is equivalent to (P <.0001). In terms of the overall clinical impression of change, 83.3% of treated subjects and 91.6% of physicians noted an improvement that lasted up to 2 years.

Vercise’s DBS system has been a remarkable treatment for patients with Parkinson’s since its introduction in 2012. It was originally evaluated in the INTREPID study (NCT01839396), where its use resulted in a 49.2% improvement in UPDRS-III scores at 12 months. The double-blind portion of the study, conducted between May 2013 and November 2017, enrolled 313 patients at 23 sites. Of these 313 patients, 196 (63%) received the DBS implant, 191 (61%) were randomized, and 160 were included in the 3-month interim analysis. During this period, both patients and reviewers were masked for the treatment group, while the unmasked programmer was responsible for programming and optimizing device settings. Of those included, 121 (76%) were randomly assigned to the active group and 39 (24%) to the control group.

From the baseline visit to 3 months after randomization, the results showed a difference in prolonged ON time without confounding dyskinesia of 3.03 hours (SD, 4.52; 95% CI, 1.3-4.7; P <.0001). During this time, investigators reported 26 serious adverse events in 20 (13%) patients. Of these, 18 events were reported in the active group and 8 in the control group. Notably, among the 196 patients pre-randomization, one death was reported that was considered unrelated to the procedure, device, or stimulation.²

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REFERENCES
1. Dueschl G, Jain R, Scholtes H, et al. Real world outcomes using a novel directional lead from a multicenter DBS registry for Parkinson’s disease. Presented at: MDS Congress 2022; September 15-18. Madrid, Spain. Summary 704.
2. Vitek JL, Jain R, Chen L, et al. Deep brain stimulation of the subthalamic nucleus with a multiple independent constant current controlled device in Parkinson’s disease (INTREPID): a multicenter, double-blind, randomized, sham-controlled study. Lancet Neurol. 2020;19(6):491-501. doi: 10.1016/S1474-4422(20)30108-3