Please use this identifier to cite or link to this item: http://bura.brunel.ac.uk/handle/2438/7012
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dc.contributor.authorO'Connell, NE-
dc.contributor.authorCossar, J-
dc.contributor.authorMarston, L-
dc.contributor.authorWand, BM-
dc.contributor.authorBunce, D-
dc.contributor.authorMoseley, GL-
dc.contributor.authorDe Souza, LH-
dc.date.accessioned2012-11-12T12:06:52Z-
dc.date.available2012-11-12T12:06:52Z-
dc.date.issued2012-
dc.identifier.citationPLoS One, 7(10): e47514, Oct 2012en_US
dc.identifier.issn1932-6203-
dc.identifier.urihttp://www.plosone.org/article/info%3Adoi/10.1371/journal.pone.0047514en
dc.identifier.urihttp://bura.brunel.ac.uk/handle/2438/7012-
dc.descriptionCopyright @ 2012 The Authors. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and 85 reproduction in any medium, provided the original author and source are credited. The article was made available through the Brunel University Open Access Publishing Fund.en_US
dc.description.abstractBackground: Many double-blind clinical trials of transcranial direct current stimulation (tDCS) use stimulus intensities of 2 mA despite the fact that blinding has not been formally validated under these conditions. The aim of this study was to test the assumption that sham 2 mA tDCS achieves effective blinding. Methods: A randomised double blind crossover trial. 100 tDCS-naïve healthy volunteers were incorrectly advised that they there were taking part in a trial of tDCS on word memory. Participants attended for two separate sessions. In each session, they completed a word memory task, then received active or sham tDCS (order randomised) at 2 mA stimulation intensity for 20 minutes and then repeated the word memory task. They then judged whether they believed they had received active stimulation and rated their confidence in that judgement. The blinded assessor noted when red marks were observed at the electrode sites post-stimulation. Results: tDCS at 2 mA was not effectively blinded. That is, participants correctly judged the stimulation condition greater than would be expected to by chance at both the first session (kappa level of agreement (κ) 0.28, 95% confidence interval (CI) 0.09 to 0.47 p = 0.005) and the second session (κ = 0.77, 95%CI 0.64 to 0.90), p = <0.001) indicating inadequate participant blinding. Redness at the reference electrode site was noticeable following active stimulation more than sham stimulation (session one, κ = 0.512, 95%CI 0.363 to 0.66, p<0.001; session two, κ = 0.677, 95%CI 0.534 to 0.82) indicating inadequate assessor blinding. Conclusions: Our results suggest that blinding in studies using tDCS at intensities of 2 mA is inadequate. Positive results from such studies should be interpreted with caution.en_US
dc.description.sponsorshipGLM is supported by the National Health & Medical Research Council of Australia ID 571090.en_US
dc.languageeng-
dc.language.isoenen_US
dc.publisherPublic Library of Scienceen_US
dc.titleRethinking clinical trials of transcranial direct current stimulation: Participant and assessor blinding is inadequate at intensities of 2mAen_US
dc.typeArticleen_US
dc.identifier.doihttp://dx.doi.org/10.1371/journal.pone.0047514-
pubs.organisational-data/Brunel-
pubs.organisational-data/Brunel/Brunel Active Staff-
pubs.organisational-data/Brunel/Brunel Active Staff/School of Health Sciences & Social Care-
pubs.organisational-data/Brunel/Brunel Active Staff/School of Health Sciences & Social Care/Physiotherapy-
pubs.organisational-data/Brunel/University Research Centres and Groups-
pubs.organisational-data/Brunel/University Research Centres and Groups/School of Health Sciences and Social Care - URCs and Groups-
pubs.organisational-data/Brunel/University Research Centres and Groups/School of Health Sciences and Social Care - URCs and Groups/Centre for Research in Rehabilitation-
Appears in Collections:Community Health and Public Health
Physiotherapy
Brunel OA Publishing Fund
Dept of Clinical Sciences Research Papers

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