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July 28, 2020; 95 (4) Article

Deep brain stimulation in early-stage Parkinson disease

Five-year outcomes

Mallory L. Hacker, Maxim Turchan, Lauren E. Heusinkveld, Amanda D. Currie, Sarah H. Millan, Anna L. Molinari, Peter E. Konrad, Thomas L. Davis, Fenna T. Phibbs, Peter Hedera, Kevin R. Cannard, Li Wang, David Charles
First published June 29, 2020, DOI: https://doi.org/10.1212/WNL.0000000000009946
Mallory L. Hacker
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.
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Maxim Turchan
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.
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Lauren E. Heusinkveld
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.
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Amanda D. Currie
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.
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Sarah H. Millan
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.
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Anna L. Molinari
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.
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Peter E. Konrad
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.
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Thomas L. Davis
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.
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Fenna T. Phibbs
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.
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Peter Hedera
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.
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Kevin R. Cannard
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.
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Li Wang
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.
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David Charles
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.
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Citation
Deep brain stimulation in early-stage Parkinson disease
Five-year outcomes
Mallory L. Hacker, Maxim Turchan, Lauren E. Heusinkveld, Amanda D. Currie, Sarah H. Millan, Anna L. Molinari, Peter E. Konrad, Thomas L. Davis, Fenna T. Phibbs, Peter Hedera, Kevin R. Cannard, Li Wang, David Charles
Neurology Jul 2020, 95 (4) e393-e401; DOI: 10.1212/WNL.0000000000009946

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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.

Glossary

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

Footnotes

  • Go to Neurology.org/N for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • See Patient Page e436

  • Class of Evidence: NPub.org/coe

  • Podcast: NPub.org/0bysrd

  • Received September 6, 2019.
  • Accepted in final form January 26, 2020.
  • © 2020 American Academy of Neurology
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Disputes & Debates: Rapid online correspondence

  • Author response: Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes
    • Mallory L. Hacker, Assistant Professor of Neurology, Vanderbilt University Medical Center (Nashville, TN)
    • Peter E. Konrad, Professor of Neuroscience & Neurosurgery, Rockefeller Neuroscience Institute, West Virginia University (Morgantown, WV)
    • Thomas L. Davis, Professor of Neurology, Vanderbilt University Medical Center (Nashville, TN)
    • David Charles, Professor of Neurology, Vanderbilt University Medical Center (Nashville, TN)
    Submitted September 05, 2020
  • Reader response: Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes
    • Christos Sidiropoulos, Movement Disorders Neurologist, Michigan State University
    Submitted August 19, 2020
  • Author response: Deep brain stimulation in early-stage Parkinson disease: Five-year outcomes
    • David Charles, Professor of Neurology, Vanderbilt University Medical Center (Nashville, TN)
    • Mallory L. Hacker, Assistant Professor of Neurology, Vanderbilt University Medical Center (Nashville, TN)
    • Thomas L. Davis, Professor of Neurology, Vanderbilt University Medical Center (Nashville, TN)
    • Peter E. Konrad, Professor of Neurosurgery, Vanderbilt University Medical Center (Nashville, TN)
    Submitted August 06, 2020
  • Reader response: Deep Brain Stimulation in Early-Stage Parkinson’s Disease: Five Year Outcomes
    • Alfonso Fasano, Neurologist, Professor of Neurology, Edmond J. Safra Program in Parkinson’s Disease, Toronto Western Hospital, University of Toronto (Toronto, ON, Canada)
    • Suvorit S. Bhowmick, Neurologist, Edmond J. Safra Program in Parkinson’s Disease, Toronto Western Hospital, University of Toronto (Toronto, ON, Canada)
    Submitted July 24, 2020
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