Deep brain stimulation (DBS) can decrease the risk for disease progression as well as the need for and complexity of medications in patients with early-stage Parkinson disease (PD) compared with optimal medical therapy alone, according to study results published in Neurology.
Previous studies reported the benefits of DBS in mid- and advanced-stage PD, but there are limited data on the long-term safety and efficacy of DBS in early-stage PD.
This study was a prospective, randomized controlled pilot trial that assessed the safety and tolerability of bilateral subthalamic nucleus (STN) DBS plus optimal drug therapy (ODT) compared with ODT alone in patients with early stage PD. All participants who completed the 2-year pilot provided written informed consent to participate in a follow-up study that included outpatient visits between 3 and 5 years after baseline. The goal of the current study was to report 5-year outcomes of STN DBS in patients with early-stage PD.
The study cohort included 28 patients (mean age, 66.1 years) who were taking PD medication between 6 months and 4 years at enrollment and completed ≥1 follow-up visit.
In both groups there was an increase in levodopa equivalent daily dose (LEDD) from baseline to 5 years. In the STN DBS group the increase was from 409±316 mg at baseline to 774±590 mg at 5 years, while in the ODT alone group LEDD increased from 491±216 mg at baseline to 1158±678 mg (odds ratio [OR], 0.26; 95% CI, 0.09-0.78; P =.02). Findings suggested that patients in the early STN DBS with ODT group required 240 mg lower LEDD (P =.04).
At baseline, the need for polypharmacy was similar between the groups, but after 5 years, early STN DBS with ODT was associated with a significantly lower probability of requiring polypharmacy (OR, 0.06; 95% CI, 0.00-0.65; P = .01).
Early STN DBS with ODT was associated with a lower probability of having worse rest tremor (OR, 0.21; 95% CI, 0.09-0.45; P <.001), and the mean rest tremor score was worse in those using ODT alone (P =.005).
As for the safety of early STN DBS for early PD, the researchers reported that the adverse event profile was similar for those in the STN DBS plus ODT group and those in the ODT alone group.
The study had several limitations, according to the researchers, including the small sample size, the open-label and single-blind design of the original pilot trial, and the cross-over of 4 participants who were originally randomly assigned to early ODT but elected to receive STN DBS during the follow-up.
“These results,” concluded the researchers, “suggest that early STN DBS+ODT is a safe Parkinson’s disease treatment with the potential to provide long-term, sustained motor benefit over standard medical therapy while reducing the need for, and complexity of, antiparkinsonian medications and their associated complications,” concluded the researchers.
Disclosure: This clinical trial was supported by Medtronic, Inc. Please see the original reference for a full list of authors’ disclosures
Hacker ML, Turchan M, Heusinkveld LE, et al. Deep brain stimulation in early-stage Parkinson’s disease: five year outcomes [published online June 29, 2020]. Neurology. doi:10.1212/WNL.0000000000009946