Data for: Deep brain stimulation in early-stage Parkinson disease

Objective: To report 5-year outcomes from the subthalamic nucleus (STN)
deep brain stimulation (DBS) in early-stage Parkinson disease (PD) pilot
clinical trial. Methods: The pilot was a prospective, single-blind
clinical trial that randomized patients with early-stage PD (Hoehn
& Yahr II off medications) to receive bilateral STN DBS plus
optimal drug therapy (ODT) vs ODT alone (IDEG050016, NCT0282152,
IRB040797). Participants who completed the 2-year trial participated in
this observational follow-up study, which included annual outpatient
visits through 5 years. This analysis includes 28 patients who were taking
PD medications for 6 months to 4 years at enrollment. Outcomes were
analyzed using both proportional odds logistic regression and linear mixed
effects models.ResultsEarly STN DBS + ODT participants required lower
levodopa equivalent daily doses (p = 0.04, β = −240 mg, 95% confidence
interval [CI] −471 to −8) and had 0.06 times the odds of requiring
polypharmacy at 5 years compared to early ODT participants (p = 0.01, odds
ratio [OR] 0.06, 95% CI 0.00 to 0.65). The odds of having worse rest
tremor for early STN DBS + ODT participants were 0.21 times those of early
ODT participants (p < 0.001, OR 0.21, 95% CI 0.09 to 0.45). The
safety profile was similar between groups. Conclusions: These results
suggest that early DBS reduces the need for and complexity of PD
medications while providing long-term motor benefit over standard medical
therapy. Further investigation is warranted, and the Food and Drug
Administration has approved the conduct of a prospective, multicenter,
pivotal clinical trial of DBS in early-stage PD (IDEG050016).
Classification of evidence: This study provides Class II evidence that DBS
implanted in early-stage PD decreases the risk of disease progression and
polypharmacy compared to optimal medical therapy alone.