La maladie de Parkinson en France (serveur d'exploration)

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Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study.

Identifieur interne : 001727 ( Ncbi/Merge ); précédent : 001726; suivant : 001728

Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study.

Auteurs : Lars Timmermann [Allemagne] ; Roshini Jain [États-Unis] ; Lilly Chen [États-Unis] ; Mohamed Maarouf [Allemagne] ; Michael T. Barbe [Allemagne] ; Niels Allert [Allemagne] ; Thomas Brücke [Autriche] ; Iris Kaiser [Autriche] ; Sebastian Beirer [Autriche] ; Fernando Sejio [Espagne] ; Esther Suarez [Espagne] ; Beatriz Lozano [Espagne] ; Claire Haegelen [France] ; Marc Vérin [France] ; Mauro Porta [Italie] ; Domenico Servello [Italie] ; Steven Gill [Royaume-Uni] ; Alan Whone [Royaume-Uni] ; Nic Van Dyck [Pays-Bas] ; Francois Alesch [Autriche]

Source :

RBID : pubmed:26027940

English descriptors

Abstract

High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease.

DOI: 10.1016/S1474-4422(15)00087-3
PubMed: 26027940

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pubmed:26027940

Le document en format XML

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<name sortKey="Beirer, Sebastian" sort="Beirer, Sebastian" uniqKey="Beirer S" first="Sebastian" last="Beirer">Sebastian Beirer</name>
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<name sortKey="Suarez, Esther" sort="Suarez, Esther" uniqKey="Suarez E" first="Esther" last="Suarez">Esther Suarez</name>
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<name sortKey="Lozano, Beatriz" sort="Lozano, Beatriz" uniqKey="Lozano B" first="Beatriz" last="Lozano">Beatriz Lozano</name>
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<name sortKey="Haegelen, Claire" sort="Haegelen, Claire" uniqKey="Haegelen C" first="Claire" last="Haegelen">Claire Haegelen</name>
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<nlm:affiliation>Centre Hospitalier Universitait du Rennes, Service de Neurochirurgie, Rennes, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
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<name sortKey="Verin, Marc" sort="Verin, Marc" uniqKey="Verin M" first="Marc" last="Vérin">Marc Vérin</name>
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<name sortKey="Porta, Mauro" sort="Porta, Mauro" uniqKey="Porta M" first="Mauro" last="Porta">Mauro Porta</name>
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<name sortKey="Servello, Domenico" sort="Servello, Domenico" uniqKey="Servello D" first="Domenico" last="Servello">Domenico Servello</name>
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<term>Electrodes, Implanted</term>
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<div type="abstract" xml:lang="en">High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease.</div>
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<Month>08</Month>
<Day>26</Day>
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<ArticleTitle>Multiple-source current steering in subthalamic nucleus deep brain stimulation for Parkinson's disease (the VANTAGE study): a non-randomised, prospective, multicentre, open-label study.</ArticleTitle>
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<AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">High-frequency deep brain stimulation (DBS) with a single electrical source is effective for motor symptom relief in patients with Parkinson's disease. We postulated that a multiple-source, constant-current device that permits well defined distribution of current would lead to motor improvement in patients with Parkinson's disease.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">We did a prospective, multicentre, non-randomised, open-label intervention study of an implantable DBS device (the VANTAGE study) at six specialist DBS centres at universities in six European countries. Patients were judged eligible if they were aged 21-75 years, had been diagnosed with bilateral idiopathic Parkinson's disease with motor symptoms for more than 5 years, had a Hoehn and Yahr score of 2 or greater, and had a Unified Parkinson's disease rating scale part III (UPDRS III) score in the medication-off state of more than 30, which improved by 33% or more after a levodopa challenge. Participants underwent bilateral implantation in the subthalamic nucleus of a multiple-source, constant-current, eight-contact, rechargeable DBS system, and were assessed 12, 26, and 52 weeks after implantation. The primary endpoint was the mean change in UPDRS III scores (assessed by site investigators who were aware of the treatment assignment) from baseline (medication-off state) to 26 weeks after first lead implantation (stimulation-on, medication-off state). This study is registered with ClinicalTrials.gov, number NCT01221948.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">Of 53 patients enrolled in the study, 40 received a bilateral implant in the subthalamic nucleus and their data contributed to the primary endpoint analysis. Improvement was noted in the UPDRS III motor score 6 months after first lead implantation (mean 13·5 [SD 6·8], 95% CI 11·3-15·7) compared with baseline (37·4 [8·9], 34·5-40·2), with a mean difference of 23·8 (SD 10·6; 95% CI 20·3-27·3; p<0·0001). One patient died of pneumonia 24 weeks after implantation, which was judged to be unrelated to the procedure. 125 adverse events were reported, the most frequent of which were dystonia, speech disorder, and apathy. 18 serious adverse events were recorded, three of which were attributed to the device or procedure (one case each of infection, migration, and respiratory depression). All serious adverse events resolved without residual effects and stimulation remained on during the study.</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">The multiple-source, constant-current, eight-contact DBS system suppressed motor symptoms effectively in patients with Parkinson's disease, with an acceptable safety profile. Future trials are needed to investigate systematically the potential benefits of this system on postoperative outcome and its side-effects.</AbstractText>
<AbstractText Label="FUNDING" NlmCategory="BACKGROUND">Boston Scientific.</AbstractText>
<CopyrightInformation>Copyright © 2015 Elsevier Ltd. All rights reserved.</CopyrightInformation>
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<LastName>Timmermann</LastName>
<ForeName>Lars</ForeName>
<Initials>L</Initials>
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<Affiliation>Department of Neurology, University Hospital Cologne, Cologne, Germany. Electronic address: lars.timmermann@uk-koeln.de.</Affiliation>
</AffiliationInfo>
</Author>
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<LastName>Jain</LastName>
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<Affiliation>Boston Scientific, Neuromodulation, Valencia, CA, USA.</Affiliation>
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