RT Journal Article
SR Electronic
T1 Deep brain stimulation in early-stage Parkinson disease
JF Neurology
JO Neurology
FD Lippincott Williams & Wilkins
SP e393
OP e401
DO 10.1212/WNL.0000000000009946
VO 95
IS 4
A1 Hacker, Mallory L.
A1 Turchan, Maxim
A1 Heusinkveld, Lauren E.
A1 Currie, Amanda D.
A1 Millan, Sarah H.
A1 Molinari, Anna L.
A1 Konrad, Peter E.
A1 Davis, Thomas L.
A1 Phibbs, Fenna T.
A1 Hedera, Peter
A1 Cannard, Kevin R.
A1 Wang, Li
A1 Charles, David
YR 2020
UL http://n.neurology.org/content/95/4/e393.abstract
AB 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.Results Early 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.AE=adverse event; CI=confidence interval; CRC=Clinical Research Center; DBS=deep brain stimulation; FDA=Food and Drug Administration; IPG=implanted pulse generator; IRB=institutional review board; LEDD=levodopa equivalent daily dose; ODT=optimal drug therapy; OR=odds ratio; PD=Parkinson disease; PDQ-39=Parkinson's Disease Questionnaire–39; STN=subthalamic nucleus; TEED=total electrical energy delivered; UPDRS-III=Unified Parkinson's Disease Rating Scale, part III