A randomized trial of deep-brain stimulation for Parkinson's disease.
Günther Deuschl
(1)
,
Carmen Schade-Brittinger
(2)
,
Paul Krack
(1)
,
Jens Volkmann
(1)
,
Helmut Schäfer
(2)
,
Kai Bötzel
(3)
,
Christine Daniels
(1)
,
Angela Deutschländer
(3)
,
Ulrich Dillmann
(4)
,
Wilhelm Eisner
(5)
,
Doreen Gruber
(6)
,
Wolfgang Hamel
(1)
,
Jan Herzog
(1)
,
Rüdiger Hilker
(7)
,
Stephan Klebe
(1)
,
Manja Kloss
(8)
,
Jan Koy
(9)
,
Martin Krause
(8)
,
Andreas Kupsch
(6)
,
Delia Lorenz
(1)
,
Stefan Lorenzl
(3)
,
H Maximilian Mehdorn
(1)
,
Jean Richard Moringlane
(4)
,
Wolfgang Oertel
(2)
,
Marcus O. Pinsker
(1)
,
Heinz Reichmann
(9)
,
Alexander Reuss
(2)
,
Gerd-Helge Schneider
(6)
,
Alfons Schnitzler
(10)
,
Ulrich Steude
(3)
,
Volker Sturm
(7)
,
Lars Timmermann
(10)
,
Volker Tronnier
(8)
,
Thomas Trottenberg
(6)
,
Lars Wojtecki
(10)
,
Elisabeth Wolf
(5)
,
Werner Poewe
(5)
,
Jürgen Voges
(7)
1
CAU -
Christian-Albrechts-Universität zu Kiel = Christian-Albrechts University of Kiel = Université Christian-Albrechts de Kiel
2 Somnomar
3 LMU - Ludwig-Maximilians University [Munich]
4 Homburg University
5 IMU - Innsbruck Medical University = Medizinische Universität Innsbruck
6 Charité Hospital
7 University of Cologne
8 Universität Heidelberg [Heidelberg] = Heidelberg University
9 Dresden University
10 Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf]
2 Somnomar
3 LMU - Ludwig-Maximilians University [Munich]
4 Homburg University
5 IMU - Innsbruck Medical University = Medizinische Universität Innsbruck
6 Charité Hospital
7 University of Cologne
8 Universität Heidelberg [Heidelberg] = Heidelberg University
9 Dresden University
10 Heinrich Heine Universität Düsseldorf = Heinrich Heine University [Düsseldorf]
Résumé
BACKGROUND: Neurostimulation of the subthalamic nucleus reduces levodopa-related motor complications in advanced Parkinson's disease. We compared this treatment plus medication with medical management. METHODS: In this randomized-pairs trial, we enrolled 156 patients with advanced Parkinson's disease and severe motor symptoms. The primary end points were the changes from baseline to six months in the quality of life, as assessed by the Parkinson's Disease Questionnaire (PDQ-39), and the severity of symptoms without medication, according to the Unified Parkinson's Disease Rating Scale, part III (UPDRS-III). RESULTS: Pairwise comparisons showed that neurostimulation, as compared with medication alone, caused greater improvements from 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 improvements of 9.5 and 19.6 points, respectively. Neurostimulation resulted in improvements of 24 to 38 percent in the PDQ-39 subscales for mobility, activities of daily living, emotional well-being, stigma, and bodily discomfort. Serious adverse events were more common with neurostimulation than with medication alone (13 percent vs. 4 percent, P<0.04) and included a fatal intracerebral hemorrhage. The overall frequency of adverse events was higher in the medication group (64 percent vs. 50 percent, P=0.08). CONCLUSIONS: In this six-month study of patients under 75 years of age with severe motor complications of Parkinson's disease, neurostimulation of the subthalamic nucleus was more effective than medical management alone. (ClinicalTrials.gov number, NCT00196911 [ClinicalTrials.gov].).