A Randomized Trial of Deep-Brain Stimulation for Parkinson's Disease
Günther Deuschl, M.D., Ph.D., Carmen Schade-Brittinger, Paul Krack, M.D., Ph.D., Jens Volkmann, M.D., Ph.D., Helmut Schäfer, Ph.D., Kai Bötzel, M.D., Ph.D., Christine Daniels, M.D., Angela Deutschländer, M.D., Ulrich Dillmann, M.D., Ph.D., Wilhelm Eisner, M.D., Ph.D., Doreen Gruber, M.D., Wolfgang Hamel, M.D., Jan Herzog, M.D., Rüdiger Hilker, M.D., Ph.D., Stephan Klebe, M.D., Manja Kloß, M.D., Jan Koy, M.D., Martin Krause, M.D., Andreas Kupsch, M.D., Ph.D., Delia Lorenz, M.D., Stefan Lorenzl, M.D., Ph.D., H. Maximilian Mehdorn, M.D., Ph.D., Jean Richard Moringlane, M.D., Ph.D., Wolfgang Oertel, M.D., Ph.D., Marcus O. Pinsker, M.D., Heinz Reichmann, M.D., Ph.D., Alexander Reuß, M.S., Gerd-Helge Schneider, M.D., Alfons Schnitzler, M.D., Ph.D., Ulrich Steude, M.D., Ph.D., Volker Sturm, M.D., Ph.D., Lars Timmermann, M.D., Volker Tronnier, M.D., Ph.D., Thomas Trottenberg, M.D., Lars Wojtecki, M.D., Elisabeth Wolf, M.D., Werner Poewe, M.D., Ph.D., Jürgen Voges, M.D., Ph.D., for the German Parkinson Study Group, Neurostimulation Section
Background Neurostimulation of the subthalamic nucleus reduceslevodopa-related motor complications in advanced Parkinson'sdisease. We compared this treatment plus medication with medicalmanagement.
Methods In this randomized-pairs trial, we enrolled 156 patientswith advanced Parkinson's disease and severe motor symptoms.The primary end points were the changes from baseline to sixmonths in the quality of life, as assessed by the Parkinson'sDisease Questionnaire (PDQ-39), and the severity of symptomswithout medication, according to the Unified Parkinson's DiseaseRating Scale, part III (UPDRS-III).
Results Pairwise comparisons showed that neurostimulation, ascompared with medication alone, caused greater improvementsfrom baseline to six months in the PDQ-39 (50 of 78 pairs, P=0.02)and the UPDRS-III (55 of 78, P<0.001), with mean improvementsof 9.5 and 19.6 points, respectively. Neurostimulation resultedin improvements of 24 to 38 percent in the PDQ-39 subscalesfor mobility, activities of daily living, emotional well-being,stigma, and bodily discomfort. Serious adverse events were morecommon with neurostimulation than with medication alone (13percent vs. 4 percent, P<0.04) and included a fatal intracerebralhemorrhage. The overall frequency of adverse events was higherin the medication group (64 percent vs. 50 percent, P=0.08).
Conclusions In this six-month study of patients under 75 yearsof age with severe motor complications of Parkinson's disease,neurostimulation of the subthalamic nucleus was more effectivethan medical management alone. (ClinicalTrials.gov number, NCT00196911
[ClinicalTrials.gov]
.)
Source Information
From Christian Albrechts University, Kiel (G.D., P.K., J.V., C.D., W.H., J.H., S.K., D.L., H.M.M., M.O.P.); Philipps University, Marburg (C.S.-B., H.S., W.O., A.R.); Ludwig Maximilians University, Munich (K.B., A.D., S.L., U.S.); Homburg University, Homburg (U.D., J.R.M.); Charité Hospital, Humboldt University, Berlin (D.G., A.K., G.-H.S., T.T.); Cologne University, Cologne, (R.H., V.S., J.V.); Heidelberg University, Heidelberg (M.Kloß, M.Krause, V.T.); Dresden University, Dresden (J.K., H.R.); and Heinrich Heine University, Dusseldorf (A.S., L.T., L.W.) all in Germany; and Innsbruck Medical University, Innsbruck, Austria (W.E., E.W., W.P.).
Address reprint requests to Dr. Deuschl at the Department of Neurology, Universitätsklinikum Schleswig-Holstein, Campus Kiel, Christian Albrechts University, Schittenhelmstrasse 10, 24105 Kiel, Germany, or at g.deuschl{at}neurologie.uni-kiel.de.
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