Methylphenidate for gait hypokinesia and freezing in patients with Parkinson's disease undergoing subthalamic stimulation: a multicentre, parallel, randomised, placebo-controlled trial.
Identifieur interne : 000856 ( PubMed/Corpus ); précédent : 000855; suivant : 000857Methylphenidate for gait hypokinesia and freezing in patients with Parkinson's disease undergoing subthalamic stimulation: a multicentre, parallel, randomised, placebo-controlled trial.
Auteurs : Caroline Moreau ; Arnaud Delval ; Luc Defebvre ; Kathy Dujardin ; Alain Duhamel ; Gregory Petyt ; Isabelle Vuillaume ; Jean-Christophe Corvol ; Christine Brefel-Courbon ; Fabienne Ory-Magne ; Dominique Guehl ; Alexandre Eusebio ; Valérie Fraix ; Pierre-Jean Saulnier ; Ouhaid Lagha-Boukbiza ; Frank Durif ; Mirela Faighel ; Caroline Giordana ; Sophie Drapier ; David Maltête ; Christine Tranchant ; Jean-Luc Houeto ; Bettina Debû ; Bernard Sablonniere ; Jean-Philippe Azulay ; François Tison ; Olivier Rascol ; Marie Vidailhet ; Alain Destée ; Bastiaan R. Bloem ; Régis Bordet ; David DevosSource :
- The Lancet. Neurology [ 1474-4465 ] ; 2012.
English descriptors
- KwdEn :
- Aged, Deep Brain Stimulation, Dopamine Uptake Inhibitors (therapeutic use), Double-Blind Method, Female, France, Gait Disorders, Neurologic (etiology), Gait Disorders, Neurologic (therapy), Humans, Hypokinesia (etiology), Hypokinesia (therapy), Male, Methylphenidate (therapeutic use), Middle Aged, Parkinson Disease (complications), Parkinson Disease (therapy), Treatment Outcome.
- MESH :
- chemical , therapeutic use : Dopamine Uptake Inhibitors, Methylphenidate.
- geographic : France.
- complications : Parkinson Disease.
- etiology : Gait Disorders, Neurologic, Hypokinesia.
- therapy : Gait Disorders, Neurologic, Hypokinesia, Parkinson Disease.
- Aged, Deep Brain Stimulation, Double-Blind Method, Female, Humans, Male, Middle Aged, Treatment Outcome.
Abstract
Despite optimum medical management, many patients with Parkinson's disease are incapacitated by gait disorders including freezing of gait. We aimed to assess whether methylphenidate--through its combined action on dopamine and noradrenaline reuptake--would improve gait disorders and freezing of gate in patients with advanced Parkinson's disease without dementia who also received subthalamic nucleus stimulation.
DOI: 10.1016/S1474-4422(12)70106-0
PubMed: 22658702
Links to Exploration step
pubmed:22658702Le document en format XML
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Bloem</name></author><author><name sortKey="Bordet, Regis" sort="Bordet, Regis" uniqKey="Bordet R" first="Régis" last="Bordet">Régis Bordet</name></author><author><name sortKey="Devos, David" sort="Devos, David" uniqKey="Devos D" first="David" last="Devos">David Devos</name></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2012">2012</date><idno type="RBID">pubmed:22658702</idno><idno type="pmid">22658702</idno><idno type="doi">10.1016/S1474-4422(12)70106-0</idno><idno type="wicri:Area/PubMed/Corpus">000856</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">000856</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Methylphenidate for gait hypokinesia and freezing in patients with Parkinson's disease undergoing subthalamic stimulation: a multicentre, parallel, randomised, placebo-controlled trial.</title><author><name sortKey="Moreau, Caroline" sort="Moreau, Caroline" uniqKey="Moreau C" first="Caroline" last="Moreau">Caroline Moreau</name><affiliation><nlm:affiliation>Department of Movement Disorders and Neurology, Lille Nord de France University, CHU Lille, Lille, France.</nlm:affiliation></affiliation></author><author><name sortKey="Delval, Arnaud" sort="Delval, Arnaud" uniqKey="Delval A" first="Arnaud" last="Delval">Arnaud Delval</name></author><author><name sortKey="Defebvre, Luc" sort="Defebvre, Luc" uniqKey="Defebvre L" first="Luc" last="Defebvre">Luc Defebvre</name></author><author><name sortKey="Dujardin, Kathy" sort="Dujardin, Kathy" uniqKey="Dujardin K" first="Kathy" last="Dujardin">Kathy Dujardin</name></author><author><name sortKey="Duhamel, Alain" sort="Duhamel, Alain" uniqKey="Duhamel A" first="Alain" last="Duhamel">Alain Duhamel</name></author><author><name sortKey="Petyt, Gregory" sort="Petyt, Gregory" uniqKey="Petyt G" first="Gregory" last="Petyt">Gregory Petyt</name></author><author><name sortKey="Vuillaume, Isabelle" sort="Vuillaume, Isabelle" uniqKey="Vuillaume I" first="Isabelle" last="Vuillaume">Isabelle Vuillaume</name></author><author><name sortKey="Corvol, Jean Christophe" sort="Corvol, Jean Christophe" uniqKey="Corvol J" first="Jean-Christophe" last="Corvol">Jean-Christophe Corvol</name></author><author><name sortKey="Brefel Courbon, Christine" sort="Brefel Courbon, Christine" uniqKey="Brefel Courbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name></author><author><name sortKey="Ory Magne, Fabienne" sort="Ory Magne, Fabienne" uniqKey="Ory Magne F" first="Fabienne" last="Ory-Magne">Fabienne Ory-Magne</name></author><author><name sortKey="Guehl, Dominique" sort="Guehl, Dominique" uniqKey="Guehl D" first="Dominique" last="Guehl">Dominique Guehl</name></author><author><name sortKey="Eusebio, Alexandre" sort="Eusebio, Alexandre" uniqKey="Eusebio A" first="Alexandre" last="Eusebio">Alexandre Eusebio</name></author><author><name sortKey="Fraix, Valerie" sort="Fraix, Valerie" uniqKey="Fraix V" first="Valérie" last="Fraix">Valérie Fraix</name></author><author><name sortKey="Saulnier, Pierre Jean" sort="Saulnier, Pierre Jean" uniqKey="Saulnier P" first="Pierre-Jean" last="Saulnier">Pierre-Jean Saulnier</name></author><author><name sortKey="Lagha Boukbiza, Ouhaid" sort="Lagha Boukbiza, Ouhaid" uniqKey="Lagha Boukbiza O" first="Ouhaid" last="Lagha-Boukbiza">Ouhaid Lagha-Boukbiza</name></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name></author><author><name sortKey="Faighel, Mirela" sort="Faighel, Mirela" uniqKey="Faighel M" first="Mirela" last="Faighel">Mirela Faighel</name></author><author><name sortKey="Giordana, Caroline" sort="Giordana, Caroline" uniqKey="Giordana C" first="Caroline" last="Giordana">Caroline Giordana</name></author><author><name sortKey="Drapier, Sophie" sort="Drapier, Sophie" uniqKey="Drapier S" first="Sophie" last="Drapier">Sophie Drapier</name></author><author><name sortKey="Maltete, David" sort="Maltete, David" uniqKey="Maltete D" first="David" last="Maltête">David Maltête</name></author><author><name sortKey="Tranchant, Christine" sort="Tranchant, Christine" uniqKey="Tranchant C" first="Christine" last="Tranchant">Christine Tranchant</name></author><author><name sortKey="Houeto, Jean Luc" sort="Houeto, Jean Luc" uniqKey="Houeto J" first="Jean-Luc" last="Houeto">Jean-Luc Houeto</name></author><author><name sortKey="Debu, Bettina" sort="Debu, Bettina" uniqKey="Debu B" first="Bettina" last="Debû">Bettina Debû</name></author><author><name sortKey="Sablonniere, Bernard" sort="Sablonniere, Bernard" uniqKey="Sablonniere B" first="Bernard" last="Sablonniere">Bernard Sablonniere</name></author><author><name sortKey="Azulay, Jean Philippe" sort="Azulay, Jean Philippe" uniqKey="Azulay J" first="Jean-Philippe" last="Azulay">Jean-Philippe Azulay</name></author><author><name sortKey="Tison, Francois" sort="Tison, Francois" uniqKey="Tison F" first="François" last="Tison">François Tison</name></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name></author><author><name sortKey="Vidailhet, Marie" sort="Vidailhet, Marie" uniqKey="Vidailhet M" first="Marie" last="Vidailhet">Marie Vidailhet</name></author><author><name sortKey="Destee, Alain" sort="Destee, Alain" uniqKey="Destee A" first="Alain" last="Destée">Alain Destée</name></author><author><name sortKey="Bloem, Bastiaan R" sort="Bloem, Bastiaan R" uniqKey="Bloem B" first="Bastiaan R" last="Bloem">Bastiaan R. Bloem</name></author><author><name sortKey="Bordet, Regis" sort="Bordet, Regis" uniqKey="Bordet R" first="Régis" last="Bordet">Régis Bordet</name></author><author><name sortKey="Devos, David" sort="Devos, David" uniqKey="Devos D" first="David" last="Devos">David Devos</name></author></analytic><series><title level="j">The Lancet. Neurology</title><idno type="eISSN">1474-4465</idno><imprint><date when="2012" type="published">2012</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Aged</term><term>Deep Brain Stimulation</term><term>Dopamine Uptake Inhibitors (therapeutic use)</term><term>Double-Blind Method</term><term>Female</term><term>France</term><term>Gait Disorders, Neurologic (etiology)</term><term>Gait Disorders, Neurologic (therapy)</term><term>Humans</term><term>Hypokinesia (etiology)</term><term>Hypokinesia (therapy)</term><term>Male</term><term>Methylphenidate (therapeutic use)</term><term>Middle Aged</term><term>Parkinson Disease (complications)</term><term>Parkinson Disease (therapy)</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dopamine Uptake Inhibitors</term><term>Methylphenidate</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term></keywords><keywords scheme="MESH" qualifier="complications" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" qualifier="etiology" xml:lang="en"><term>Gait Disorders, Neurologic</term><term>Hypokinesia</term></keywords><keywords scheme="MESH" qualifier="therapy" xml:lang="en"><term>Gait Disorders, Neurologic</term><term>Hypokinesia</term><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Aged</term><term>Deep Brain Stimulation</term><term>Double-Blind Method</term><term>Female</term><term>Humans</term><term>Male</term><term>Middle Aged</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Despite optimum medical management, many patients with Parkinson's disease are incapacitated by gait disorders including freezing of gait. We aimed to assess whether methylphenidate--through its combined action on dopamine and noradrenaline reuptake--would improve gait disorders and freezing of gate in patients with advanced Parkinson's disease without dementia who also received subthalamic nucleus stimulation.</div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">22658702</PMID><DateCreated><Year>2012</Year><Month>06</Month><Day>19</Day></DateCreated><DateCompleted><Year>2012</Year><Month>09</Month><Day>20</Day></DateCompleted><DateRevised><Year>2016</Year><Month>07</Month><Day>18</Day></DateRevised><Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-4465</ISSN><JournalIssue CitedMedium="Internet"><Volume>11</Volume><Issue>7</Issue><PubDate><Year>2012</Year><Month>Jul</Month></PubDate></JournalIssue><Title>The Lancet. Neurology</Title><ISOAbbreviation>Lancet Neurol</ISOAbbreviation></Journal><ArticleTitle>Methylphenidate for gait hypokinesia and freezing in patients with Parkinson's disease undergoing subthalamic stimulation: a multicentre, parallel, randomised, placebo-controlled trial.</ArticleTitle><Pagination><MedlinePgn>589-96</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1016/S1474-4422(12)70106-0</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Despite optimum medical management, many patients with Parkinson's disease are incapacitated by gait disorders including freezing of gait. We aimed to assess whether methylphenidate--through its combined action on dopamine and noradrenaline reuptake--would improve gait disorders and freezing of gate in patients with advanced Parkinson's disease without dementia who also received subthalamic nucleus stimulation.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">This multicentre, parallel, double-blind, placebo-controlled, randomised trial was done in 13 movement disorders departments in France between October, 2009, and December, 2011. Eligible patients were younger than 80 years and had Parkinson's disease, severe gait disorders, and freezing of gate despite optimised treatment of motor fluctuations with dopaminergic drugs and subthalamic stimulation. We randomly assigned patients (1:1 with a computer random-number generator in blocks of four) to receive methylphenidate (1 mg/kg per day) or placebo capsules for 90 days. Patients, their carers, study staff, investigators, and data analysts were masked to treatment allocation. To control for confounding effects of levodopa we assessed patients under standardised conditions with an acute levodopa challenge. Our primary outcome was a change in the number of steps during the stand-walk-sit (SWS) test without levodopa. We compared the respective mean numbers of steps at day 90 in the methylphenidate and placebo groups in a covariance analysis and adjusted for baseline differences. This trial is registered with ClinicalTrials.gov, number NCT00914095.</AbstractText><AbstractText Label="FINDINGS" NlmCategory="RESULTS">We screened 81 patients and randomly assigned 35 to receive methylphenidate and 34 to receive placebo. 33 patients in the methylphenidate group and 32 patients in the placebo group completed the study. Efficacy outcomes were assessed in the patients who completed the study. Compared with patients in the placebo group (median 33 steps [IQR 26-45]), the patients in the methylphenidate group made fewer steps at 90 days (31 [26-42], F((1, 62))=6·1, p=0·017, adjusted size effect 0·61). Adverse events were analysed in all randomly assigned patients. There were significantly more adverse events in the methylphenidate group compared with placebo. Patients on methylphenidate had a significant increase in heart rate (mean 3·6 [SD 7·2] beats per min) and decrease in weight (mean 2·2 [SD 1·8] kg) compared with the placebo group.</AbstractText><AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">Methylphenidate improved gait hypokinesia and freezing in patients with advanced Parkinson's disease receiving subthalamic nucleus stimulation. Methylphenidate represents a therapeutic option in the treatment of gait disorders at the advanced stage of Parkinson's disease. The long term risk-benefit balance should be further studied.</AbstractText><AbstractText Label="FUNDING" NlmCategory="BACKGROUND">French Ministry of Health and Novartis Pharma.</AbstractText><CopyrightInformation>Copyright © 2012 Elsevier Ltd. All rights reserved.</CopyrightInformation></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Moreau</LastName><ForeName>Caroline</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Department of Movement Disorders and Neurology, Lille Nord de France University, CHU Lille, Lille, France.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Delval</LastName><ForeName>Arnaud</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Defebvre</LastName><ForeName>Luc</ForeName><Initials>L</Initials></Author><Author ValidYN="Y"><LastName>Dujardin</LastName><ForeName>Kathy</ForeName><Initials>K</Initials></Author><Author ValidYN="Y"><LastName>Duhamel</LastName><ForeName>Alain</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Petyt</LastName><ForeName>Gregory</ForeName><Initials>G</Initials></Author><Author ValidYN="Y"><LastName>Vuillaume</LastName><ForeName>Isabelle</ForeName><Initials>I</Initials></Author><Author ValidYN="Y"><LastName>Corvol</LastName><ForeName>Jean-Christophe</ForeName><Initials>JC</Initials></Author><Author ValidYN="Y"><LastName>Brefel-Courbon</LastName><ForeName>Christine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Ory-Magne</LastName><ForeName>Fabienne</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Guehl</LastName><ForeName>Dominique</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Eusebio</LastName><ForeName>Alexandre</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Fraix</LastName><ForeName>Valérie</ForeName><Initials>V</Initials></Author><Author ValidYN="Y"><LastName>Saulnier</LastName><ForeName>Pierre-Jean</ForeName><Initials>PJ</Initials></Author><Author ValidYN="Y"><LastName>Lagha-Boukbiza</LastName><ForeName>Ouhaid</ForeName><Initials>O</Initials></Author><Author ValidYN="Y"><LastName>Durif</LastName><ForeName>Frank</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Faighel</LastName><ForeName>Mirela</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Giordana</LastName><ForeName>Caroline</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Drapier</LastName><ForeName>Sophie</ForeName><Initials>S</Initials></Author><Author ValidYN="Y"><LastName>Maltête</LastName><ForeName>David</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><LastName>Tranchant</LastName><ForeName>Christine</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Houeto</LastName><ForeName>Jean-Luc</ForeName><Initials>JL</Initials></Author><Author ValidYN="Y"><LastName>Debû</LastName><ForeName>Bettina</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Sablonniere</LastName><ForeName>Bernard</ForeName><Initials>B</Initials></Author><Author ValidYN="Y"><LastName>Azulay</LastName><ForeName>Jean-Philippe</ForeName><Initials>JP</Initials></Author><Author ValidYN="Y"><LastName>Tison</LastName><ForeName>François</ForeName><Initials>F</Initials></Author><Author ValidYN="Y"><LastName>Rascol</LastName><ForeName>Olivier</ForeName><Initials>O</Initials></Author><Author ValidYN="Y"><LastName>Vidailhet</LastName><ForeName>Marie</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Destée</LastName><ForeName>Alain</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Bloem</LastName><ForeName>Bastiaan R</ForeName><Initials>BR</Initials></Author><Author ValidYN="Y"><LastName>Bordet</LastName><ForeName>Régis</ForeName><Initials>R</Initials></Author><Author ValidYN="Y"><LastName>Devos</LastName><ForeName>David</ForeName><Initials>D</Initials></Author><Author ValidYN="Y"><CollectiveName>Parkgait-II study group</CollectiveName></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT00914095</AccessionNumber></AccessionNumberList></DataBank></DataBankList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType><PublicationType UI="D013485">Research Support, Non-U.S. Gov't</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2012</Year><Month>06</Month><Day>01</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Neurol</MedlineTA><NlmUniqueID>101139309</NlmUniqueID><ISSNLinking>1474-4422</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D018765">Dopamine Uptake 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