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 : 000578 ( Main/Merge ); précédent : 000577; suivant : 000579

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.

Url:
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="Servello, Domenico" sort="Servello, Domenico" uniqKey="Servello D" first="Domenico" last="Servello">Domenico Servello</name>
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<name sortKey="Whone, Alan" sort="Whone, Alan" uniqKey="Whone A" first="Alan" last="Whone">Alan Whone</name>
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<title xml:lang="en">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.</title>
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<name sortKey="Kaiser, Iris" sort="Kaiser, Iris" uniqKey="Kaiser I" first="Iris" last="Kaiser">Iris Kaiser</name>
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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="Sejio, Fernando" sort="Sejio, Fernando" uniqKey="Sejio F" first="Fernando" last="Sejio">Fernando Sejio</name>
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<country xml:lang="fr">Espagne</country>
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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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<country xml:lang="fr">Espagne</country>
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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>
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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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<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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<ref type="url">http://incr.fr/recherche/23-ea-4712-comportements-et-noyaux-gris-centraux</ref>
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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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<orgName>Movement Disorders and Tourette Centre</orgName>
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<addrLine>IRCCS Galeazzi;Milan</addrLine>
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</hal:affiliation>
<country>Italie</country>
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<author>
<name sortKey="Servello, Domenico" sort="Servello, Domenico" uniqKey="Servello D" first="Domenico" last="Servello">Domenico Servello</name>
</author>
<author>
<name sortKey="Gill, Steven" sort="Gill, Steven" uniqKey="Gill S" first="Steven" last="Gill">Steven Gill</name>
</author>
<author>
<name sortKey="Whone, Alan" sort="Whone, Alan" uniqKey="Whone A" first="Alan" last="Whone">Alan Whone</name>
</author>
<author>
<name sortKey="Van Dyck, Nic" sort="Van Dyck, Nic" uniqKey="Van Dyck N" first="Nic" last="Van Dyck">Nic Van Dyck</name>
</author>
<author>
<name sortKey="Alesch, Francois" sort="Alesch, Francois" uniqKey="Alesch F" first="Francois" last="Alesch">Francois Alesch</name>
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<idno type="DOI">10.1016/S1474-4422(15)00087-3</idno>
<series>
<title level="j">Lancet Neurology</title>
<idno type="ISSN">1474-4422</idno>
<imprint>
<date type="datePub">2015</date>
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<div type="abstract" xml:lang="en">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. 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. Findings 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. Interpretation 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. Funding Boston Scientific.</div>
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<title xml:lang="en">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.</title>
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<name sortKey="Timmermann, Lars" sort="Timmermann, Lars" uniqKey="Timmermann L" first="Lars" last="Timmermann">Lars Timmermann</name>
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<nlm:affiliation>Department of Neurology, University Hospital Cologne, Cologne, Germany. Electronic address: lars.timmermann@uk-koeln.de.</nlm:affiliation>
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<country xml:lang="fr">États-Unis</country>
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<wicri:regionArea>Department of Stereotaxy and Functional Neurosurgery, University Hospital Cologne, Cologne</wicri:regionArea>
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<nlm:affiliation>Wilhelminenspital, Vienna, Austria.</nlm:affiliation>
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<name sortKey="Kaiser, Iris" sort="Kaiser, Iris" uniqKey="Kaiser I" first="Iris" last="Kaiser">Iris Kaiser</name>
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<nlm:affiliation>Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.</nlm:affiliation>
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<wicri:regionArea>Department of Neurosurgery, Medical University of Vienna, Vienna</wicri:regionArea>
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<settlement type="city">Vienne (Autriche)</settlement>
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<settlement type="city">Vienne (Autriche)</settlement>
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<wicri:regionArea>Servicio de Neurocirugía, Instituto de Neurociencias, Hospital Universitario Central de Asturias, Oviedo</wicri:regionArea>
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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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<nlm:affiliation>Servicio de Neurocirugía, Instituto de Neurociencias, Hospital Universitario Central de Asturias, Oviedo, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
<wicri:regionArea>Servicio de Neurocirugía, Instituto de Neurociencias, Hospital Universitario Central de Asturias, Oviedo</wicri:regionArea>
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<nlm:affiliation>Servicio de Neurocirugía, Instituto de Neurociencias, Hospital Universitario Central de Asturias, Oviedo, Spain.</nlm:affiliation>
<country xml:lang="fr">Espagne</country>
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<affiliation wicri:level="3">
<nlm:affiliation>Centre Hospitalier Universitait du Rennes, Service de Neurochirurgie, Rennes, France.</nlm:affiliation>
<country xml:lang="fr">France</country>
<wicri:regionArea>Centre Hospitalier Universitait du Rennes, Service de Neurochirurgie, Rennes</wicri:regionArea>
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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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<country xml:lang="fr">France</country>
<wicri:regionArea>Service de Neurologie, Hôpital Pontchaillou, Rennes</wicri:regionArea>
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<region type="region">Région Bretagne</region>
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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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<nlm:affiliation>Department of Functional Neurosurgery, IRCCS Galeazzi Hospital, Milan, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Functional Neurosurgery, IRCCS Galeazzi Hospital, Milan</wicri:regionArea>
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<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
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<name sortKey="Servello, Domenico" sort="Servello, Domenico" uniqKey="Servello D" first="Domenico" last="Servello">Domenico Servello</name>
<affiliation wicri:level="3">
<nlm:affiliation>Department of Functional Neurosurgery, IRCCS Galeazzi Hospital, Milan, Italy.</nlm:affiliation>
<country xml:lang="fr">Italie</country>
<wicri:regionArea>Department of Functional Neurosurgery, IRCCS Galeazzi Hospital, Milan</wicri:regionArea>
<placeName>
<settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
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<name sortKey="Gill, Steven" sort="Gill, Steven" uniqKey="Gill S" first="Steven" last="Gill">Steven Gill</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Neurosurgery, Southmead Hospital, Bristol, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Neurosurgery, Southmead Hospital, Bristol</wicri:regionArea>
<wicri:noRegion>Bristol</wicri:noRegion>
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<name sortKey="Whone, Alan" sort="Whone, Alan" uniqKey="Whone A" first="Alan" last="Whone">Alan Whone</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Neurology, Southmead Hospital, Bristol, UK.</nlm:affiliation>
<country xml:lang="fr">Royaume-Uni</country>
<wicri:regionArea>Department of Neurology, Southmead Hospital, Bristol</wicri:regionArea>
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<name sortKey="Van Dyck, Nic" sort="Van Dyck, Nic" uniqKey="Van Dyck N" first="Nic" last="Van Dyck">Nic Van Dyck</name>
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<nlm:affiliation>Boston Scientific, Neuromodulation, Maastricht, Netherlands.</nlm:affiliation>
<country xml:lang="fr">Pays-Bas</country>
<wicri:regionArea>Boston Scientific, Neuromodulation, Maastricht</wicri:regionArea>
<wicri:noRegion>Maastricht</wicri:noRegion>
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<name sortKey="Alesch, Francois" sort="Alesch, Francois" uniqKey="Alesch F" first="Francois" last="Alesch">Francois Alesch</name>
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<nlm:affiliation>Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurosurgery, Medical University of Vienna, Vienna</wicri:regionArea>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
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<title xml:lang="en">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.</title>
<author>
<name sortKey="Timmermann, Lars" sort="Timmermann, Lars" uniqKey="Timmermann L" first="Lars" last="Timmermann">Lars Timmermann</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Neurology, University Hospital Cologne, Cologne, Germany. Electronic address: lars.timmermann@uk-koeln.de.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, University Hospital Cologne, Cologne</wicri:regionArea>
<wicri:noRegion>Cologne</wicri:noRegion>
<wicri:noRegion>Cologne</wicri:noRegion>
<wicri:noRegion>Cologne</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Jain, Roshini" sort="Jain, Roshini" uniqKey="Jain R" first="Roshini" last="Jain">Roshini Jain</name>
<affiliation wicri:level="2">
<nlm:affiliation>Boston Scientific, Neuromodulation, Valencia, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boston Scientific, Neuromodulation, Valencia, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Chen, Lilly" sort="Chen, Lilly" uniqKey="Chen L" first="Lilly" last="Chen">Lilly Chen</name>
<affiliation wicri:level="2">
<nlm:affiliation>Boston Scientific, Neuromodulation, Valencia, CA, USA.</nlm:affiliation>
<country xml:lang="fr">États-Unis</country>
<wicri:regionArea>Boston Scientific, Neuromodulation, Valencia, CA</wicri:regionArea>
<placeName>
<region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author>
<name sortKey="Maarouf, Mohamed" sort="Maarouf, Mohamed" uniqKey="Maarouf M" first="Mohamed" last="Maarouf">Mohamed Maarouf</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Stereotaxy and Functional Neurosurgery, University Hospital Cologne, Cologne, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Stereotaxy and Functional Neurosurgery, University Hospital Cologne, Cologne</wicri:regionArea>
<wicri:noRegion>Cologne</wicri:noRegion>
<wicri:noRegion>Cologne</wicri:noRegion>
<wicri:noRegion>Cologne</wicri:noRegion>
</affiliation>
</author>
<author>
<name sortKey="Barbe, Michael T" sort="Barbe, Michael T" uniqKey="Barbe M" first="Michael T" last="Barbe">Michael T. Barbe</name>
<affiliation wicri:level="1">
<nlm:affiliation>Department of Neurology, University Hospital Cologne, Cologne, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Department of Neurology, University Hospital Cologne, Cologne</wicri:regionArea>
<wicri:noRegion>Cologne</wicri:noRegion>
<wicri:noRegion>Cologne</wicri:noRegion>
<wicri:noRegion>Cologne</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Allert, Niels" sort="Allert, Niels" uniqKey="Allert N" first="Niels" last="Allert">Niels Allert</name>
<affiliation wicri:level="1">
<nlm:affiliation>Neurological Rehabilitation Center, Godeshoehe, Germany.</nlm:affiliation>
<country xml:lang="fr">Allemagne</country>
<wicri:regionArea>Neurological Rehabilitation Center, Godeshoehe</wicri:regionArea>
<wicri:noRegion>Godeshoehe</wicri:noRegion>
<wicri:noRegion>Godeshoehe</wicri:noRegion>
<wicri:noRegion>Godeshoehe</wicri:noRegion>
</affiliation>
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<author>
<name sortKey="Brucke, Thomas" sort="Brucke, Thomas" uniqKey="Brucke T" first="Thomas" last="Brücke">Thomas Brücke</name>
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<nlm:affiliation>Wilhelminenspital, Vienna, Austria.</nlm:affiliation>
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<nlm:affiliation>Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.</nlm:affiliation>
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<nlm:affiliation>Wilhelminenspital, Vienna, Austria.</nlm:affiliation>
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<settlement type="city">Vienne (Autriche)</settlement>
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<name sortKey="Sejio, Fernando" sort="Sejio, Fernando" uniqKey="Sejio F" first="Fernando" last="Sejio">Fernando Sejio</name>
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<nlm:affiliation>Servicio de Neurocirugía, Instituto de Neurociencias, Hospital Universitario Central de Asturias, Oviedo, Spain.</nlm:affiliation>
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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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<author>
<name sortKey="Verin, Marc" sort="Verin, Marc" uniqKey="Verin M" first="Marc" last="Vérin">Marc Vérin</name>
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<nlm:affiliation>Service de Neurologie, Hôpital Pontchaillou, Rennes, France.</nlm:affiliation>
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<name sortKey="Whone, Alan" sort="Whone, Alan" uniqKey="Whone A" first="Alan" last="Whone">Alan Whone</name>
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<nlm:affiliation>Department of Neurology, Southmead Hospital, Bristol, UK.</nlm:affiliation>
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<name sortKey="Van Dyck, Nic" sort="Van Dyck, Nic" uniqKey="Van Dyck N" first="Nic" last="Van Dyck">Nic Van Dyck</name>
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<nlm:affiliation>Boston Scientific, Neuromodulation, Maastricht, Netherlands.</nlm:affiliation>
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<author>
<name sortKey="Alesch, Francois" sort="Alesch, Francois" uniqKey="Alesch F" first="Francois" last="Alesch">Francois Alesch</name>
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<nlm:affiliation>Department of Neurosurgery, Medical University of Vienna, Vienna, Austria.</nlm:affiliation>
<country xml:lang="fr">Autriche</country>
<wicri:regionArea>Department of Neurosurgery, Medical University of Vienna, Vienna</wicri:regionArea>
<placeName>
<settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
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<series>
<title level="j">The Lancet. Neurology</title>
<idno type="eISSN">1474-4465</idno>
<imprint>
<date when="2015" type="published">2015</date>
</imprint>
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<textClass>
<keywords scheme="KwdEn" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Deep Brain Stimulation (instrumentation)</term>
<term>Deep Brain Stimulation (methods)</term>
<term>Electrodes, Implanted</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Parkinson Disease (diagnosis)</term>
<term>Parkinson Disease (therapy)</term>
<term>Prospective Studies</term>
<term>Subthalamic Nucleus (physiology)</term>
<term>Treatment Outcome</term>
</keywords>
<keywords scheme="MESH" qualifier="diagnosis" xml:lang="en">
<term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" qualifier="instrumentation" xml:lang="en">
<term>Deep Brain Stimulation</term>
</keywords>
<keywords scheme="MESH" qualifier="methods" xml:lang="en">
<term>Deep Brain Stimulation</term>
</keywords>
<keywords scheme="MESH" qualifier="physiology" xml:lang="en">
<term>Subthalamic Nucleus</term>
</keywords>
<keywords scheme="MESH" qualifier="therapy" xml:lang="en">
<term>Parkinson Disease</term>
</keywords>
<keywords scheme="MESH" xml:lang="en">
<term>Adult</term>
<term>Aged</term>
<term>Electrodes, Implanted</term>
<term>Female</term>
<term>Humans</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Prospective Studies</term>
<term>Treatment Outcome</term>
</keywords>
</textClass>
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</teiHeader>
<front>
<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>
</front>
</TEI>
</PubMed>
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