Mallory L Hacker1, Maxim Turchan2, Lauren E Heusinkveld2, Amanda D Currie2, Sarah H Millan2, Anna L Molinari2, Peter E Konrad2, Thomas L Davis2, Fenna T Phibbs2, Peter Hedera2, Kevin R Cannard2, Li Wang2, David Charles2. 1. From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD. Mallory.Hacker@vumc.org. 2. From the Departments of Neurology (M.L.H., M.T., L.E.H., A.D.C., S.H.M., A.L.M., T.L.D., F.T.P., P.H., D.C.), Neurosurgery (P.E.K.), and Biostatistics (L.W.), Vanderbilt University Medical Center, Nashville, TN; and Department of Neurology (K.R.C.), Walter Reed National Military Center, Bethesda, MD.
Abstract
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.
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.
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