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Neurostimulation for Parkinson's disease with early motor complications.
N Engl J Med. 2013 Feb 14; 368(7):610-22.NEJM

Abstract

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.).

Authors+Show Affiliations

Assistance Publique–Hôpitaux de Paris, Centre d'Investigation Clinique (CIC) 9503, Institut du Cerveau et de la Moelle Épinière, Département de Neurologie, Université Pierre et Marie Curie–Paris 6 and INSERM, Centre Hospitalier Universitaire (CHU) Pitié–Salpêtrière, Paris, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23406026

Citation

Schuepbach, W M M., et al. "Neurostimulation for Parkinson's Disease With Early Motor Complications." The New England Journal of Medicine, vol. 368, no. 7, 2013, pp. 610-22.
Schuepbach WM, Rau J, Knudsen K, et al. Neurostimulation for Parkinson's disease with early motor complications. N Engl J Med. 2013;368(7):610-22.
Schuepbach, W. M., Rau, J., Knudsen, K., Volkmann, J., Krack, P., Timmermann, L., Hälbig, 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., ... Deuschl, G. (2013). Neurostimulation for Parkinson's disease with early motor complications. The New England Journal of Medicine, 368(7), 610-22. https://doi.org/10.1056/NEJMoa1205158
Schuepbach WM, et al. Neurostimulation for Parkinson's Disease With Early Motor Complications. N Engl J Med. 2013 Feb 14;368(7):610-22. PubMed PMID: 23406026.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Neurostimulation for Parkinson's disease with early motor complications. AU - Schuepbach,W M M, AU - Rau,J, AU - Knudsen,K, AU - Volkmann,J, AU - Krack,P, AU - Timmermann,L, AU - Hälbig,T D, AU - Hesekamp,H, AU - Navarro,S M, AU - Meier,N, AU - Falk,D, AU - Mehdorn,M, AU - Paschen,S, AU - Maarouf,M, AU - Barbe,M T, AU - Fink,G R, AU - Kupsch,A, AU - Gruber,D, AU - Schneider,G-H, AU - Seigneuret,E, AU - Kistner,A, AU - Chaynes,P, AU - Ory-Magne,F, AU - Brefel Courbon,C, AU - Vesper,J, AU - Schnitzler,A, AU - Wojtecki,L, AU - Houeto,J-L, AU - Bataille,B, AU - Maltête,D, AU - Damier,P, AU - Raoul,S, AU - Sixel-Doering,F, AU - Hellwig,D, AU - Gharabaghi,A, AU - Krüger,R, AU - Pinsker,M O, AU - Amtage,F, AU - Régis,J-M, AU - Witjas,T, AU - Thobois,S, AU - Mertens,P, AU - Kloss,M, AU - Hartmann,A, AU - Oertel,W H, AU - Post,B, AU - Speelman,H, AU - Agid,Y, AU - Schade-Brittinger,C, AU - Deuschl,G, AU - ,, PY - 2013/2/15/entrez PY - 2013/2/15/pubmed PY - 2013/2/27/medline SP - 610 EP - 22 JF - The New England journal of medicine JO - N Engl J Med VL - 368 IS - 7 N2 - 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.). SN - 1533-4406 UR - https://www.unboundmedicine.com/medline/citation/23406026/Neurostimulation_for_Parkinson's_disease_with_early_motor_complications_ L2 - https://www.nejm.org/doi/10.1056/NEJMoa1205158?url_ver=Z39.88-2003&amp;rfr_id=ori:rid:crossref.org&amp;rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -