Article (Scientific journals)
Neurostimulation for Parkinson's disease with early motor complications.
Schuepbach, W. M. M.; Rau, J.; Knudsen, K. et al.
2013In The New England journal of medicine, 368 (7), p. 610-22
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Keywords :
Activities of Daily Living; Adult; Antiparkinson Agents/adverse effects/therapeutic use; Combined Modality Therapy; Dopamine Agonists/adverse effects/therapeutic use; Dyskinesias/etiology; Electric Stimulation Therapy/adverse effects; Female; Humans; Implantable Neurostimulators/adverse effects; Intention to Treat Analysis; Male; Middle Aged; Parkinson Disease/drug therapy/physiopathology/therapy; Quality of Life; Questionnaires; Subthalamic Nucleus; Treatment Outcome
Abstract :
[en] BACKGROUND: Subthalamic stimulation reduces motor disability and improves quality of life in patients with advanced Parkinson's disease who have severe levodopa-induced motor complications. We hypothesized that neurostimulation would be beneficial at an earlier stage of Parkinson's disease. METHODS: In this 2-year trial, we randomly assigned 251 patients with Parkinson's disease and early motor complications (mean age, 52 years; mean duration of disease, 7.5 years) to undergo neurostimulation plus medical therapy or medical therapy alone. The primary end point was quality of life, as assessed with the use of the Parkinson's Disease Questionnaire (PDQ-39) summary index (with scores ranging from 0 to 100 and higher scores indicating worse function). Major secondary outcomes included parkinsonian motor disability, activities of daily living, levodopa-induced motor complications (as assessed with the use of the Unified Parkinson's Disease Rating Scale, parts III, II, and IV, respectively), and time with good mobility and no dyskinesia. RESULTS: For the primary outcome of quality of life, the mean score for the neurostimulation group improved by 7.8 points, and that for the medical-therapy group worsened by 0.2 points (between-group difference in mean change from baseline to 2 years, 8.0 points; P=0.002). Neurostimulation was superior to medical therapy with respect to motor disability (P<0.001), activities of daily living (P<0.001), levodopa-induced motor complications (P<0.001), and time with good mobility and no dyskinesia (P=0.01). Serious adverse events occurred in 54.8% of the patients in the neurostimulation group and in 44.1% of those in the medical-therapy group. Serious adverse events related to surgical implantation or the neurostimulation device occurred in 17.7% of patients. An expert panel confirmed that medical therapy was consistent with practice guidelines for 96.8% of the patients in the neurostimulation group and for 94.5% of those in the medical-therapy group. CONCLUSIONS: Subthalamic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. (Funded by the German Ministry of Research and others; EARLYSTIM ClinicalTrials.gov number, NCT00354133.).
Research center :
- Luxembourg Centre for Systems Biomedicine (LCSB): Clinical & Experimental Neuroscience (Krüger Group)
Disciplines :
Genetics & genetic processes
Author, co-author :
Schuepbach, W. M. M.
Rau, J.
Knudsen, K.
Volkmann, J.
Krack, P.
Timmermann, L.
Halbig, T. D.
Hesekamp, H.
Navarro, S. M.
Meier, N.
Falk, D.
Mehdorn, M.
Paschen, S.
Maarouf, M.
Barbe, M. T.
Fink, G. R.
Kupsch, A.
Gruber, D.
Schneider, G.-H.
Seigneuret, E.
Kistner, A.
Chaynes, P.
Ory-Magne, F.
Brefel Courbon, C.
Vesper, J.
Schnitzler, A.
Wojtecki, L.
Houeto, J.-L.
Bataille, B.
Maltete, D.
Damier, P.
Raoul, S.
Sixel-Doering, F.
Hellwig, D.
Gharabaghi, A.
Krüger, Rejko ;  University of Luxembourg > Faculty of Science, Technology and Communication (FSTC) > Life Science Research Unit
Pinsker, M. O.
Amtage, F.
Regis, J.-M.
Witjas, T.
Thobois, S.
Mertens, P.
Kloss, M.
Hartmann, A.
Oertel, W. H.
Post, B.
Speelman, H.
Agid, Y.
Schade-Brittinger, C.
Deuschl, G.
More authors (40 more) Less
Language :
English
Title :
Neurostimulation for Parkinson's disease with early motor complications.
Publication date :
2013
Journal title :
The New England journal of medicine
ISSN :
0028-4793
eISSN :
1533-4406
Volume :
368
Issue :
7
Pages :
610-22
Peer reviewed :
Peer reviewed
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