- Erratum in:
- N Engl J Med. 2006 Sep 21;355(12):1289.
- Comment in:
-
N Engl J Med. 2006 Nov 23;355(21):2256; author reply 2256.
A randomized trial of deep-brain stimulation for Parkinson's disease.
Deuschl G,
Schade-Brittinger C,
Krack P,
Volkmann J,
Schäfer H,
Bötzel K,
Daniels C,
Deutschländer A,
Dillmann U,
Eisner W,
Gruber D,
Hamel W,
Herzog J,
Hilker R,
Klebe S,
Kloss M,
Koy J,
Krause M,
Kupsch A,
Lorenz D,
Lorenzl S,
Mehdorn HM,
Moringlane JR,
Oertel W,
Pinsker MO,
Reichmann H,
Reuss A,
Schneider GH,
Schnitzler A,
Steude U,
Sturm V,
Timmermann L,
Tronnier V,
Trottenberg T,
Wojtecki L,
Wolf E,
Poewe W,
Voges J;
German Parkinson Study Group, Neurostimulation Section.
Christian Albrechts University, Kiel, Germany. g.deuschl@neurologie.uni-kiel.de
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].). Copyright 2006 Massachusetts Medical Society.
PMID: 16943402 [PubMed - indexed for MEDLINE]