Neurostimulation for Parkinson's disease with early motor complications.

Schüpbach, Michael W. M.; Rau, J.; Knudsen, K.; Volkmann, J.; Krack, P.; Timmermann, L.; Hälbig, T. D.; Hesekamp, H.; Navarro, S. M.; Meier, Niklaus; Falk, D.; Mehdorn, M.; Paschen, S.; Maarouf, M.; Barbe, M. T.; Fink, G. R.; Kupsch, A.; Gruber, D.; Schneider, G.-H.; Seigneuret, E.; ... (2013). Neurostimulation for Parkinson's disease with early motor complications. New England journal of medicine NEJM, 368(7), pp. 610-622. Massachusetts Medical Society MMS 10.1056/NEJMoa1205158

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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.).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Schüpbach, Michael, Meier, Niklaus

Subjects:

600 Technology > 610 Medicine & health

ISSN:

0028-4793

Publisher:

Massachusetts Medical Society MMS

Language:

English

Submitter:

Valentina Rossetti

Date Deposited:

18 Jun 2014 14:27

Last Modified:

05 Dec 2022 14:35

Publisher DOI:

10.1056/NEJMoa1205158

PubMed ID:

23406026

BORIS DOI:

10.7892/boris.53847

URI:

https://boris.unibe.ch/id/eprint/53847

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