Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.

<h4>Background</h4>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 t...

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Autores principales:	Neil E O'Connell, John Cossar, Louise Marston, Benedict M Wand, David Bunce, G Lorimer Moseley, Lorraine H De Souza
Formato:	article
Lenguaje:	EN
Publicado:	Public Library of Science (PLoS) 2012
Materias:	Medicine R Science Q
Acceso en línea:	https://doaj.org/article/63e2058cc82b44b1a94f7bcf7080256a
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spelling	oai:doaj.org-article:63e2058cc82b44b1a94f7bcf7080256a2021-11-18T08:11:40ZRethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.1932-620310.1371/journal.pone.0047514https://doaj.org/article/63e2058cc82b44b1a94f7bcf7080256a2012-01-01T00:00:00Zhttps://www.ncbi.nlm.nih.gov/pmc/articles/pmid/23082174/pdf/?tool=EBIhttps://doaj.org/toc/1932-6203<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.Neil E O'ConnellJohn CossarLouise MarstonBenedict M WandDavid BunceG Lorimer MoseleyLorraine H De SouzaPublic Library of Science (PLoS)articleMedicineRScienceQENPLoS ONE, Vol 7, Iss 10, p e47514 (2012)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine R Science Q
spellingShingle	Medicine R Science Q Neil E O'Connell John Cossar Louise Marston Benedict M Wand David Bunce G Lorimer Moseley Lorraine H De Souza Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
description	<h4>Background</h4>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.<h4>Methods</h4>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.<h4>Results</h4>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.<h4>Conclusions</h4>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.
format	article
author	Neil E O'Connell John Cossar Louise Marston Benedict M Wand David Bunce G Lorimer Moseley Lorraine H De Souza
author_facet	Neil E O'Connell John Cossar Louise Marston Benedict M Wand David Bunce G Lorimer Moseley Lorraine H De Souza
author_sort	Neil E O'Connell
title	Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
title_short	Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
title_full	Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
title_fullStr	Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
title_full_unstemmed	Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
title_sort	rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2ma.
publisher	Public Library of Science (PLoS)
publishDate	2012
url	https://doaj.org/article/63e2058cc82b44b1a94f7bcf7080256a
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Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.

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