The Influence of Skin Redness on Blinding in Transcranial Direct Current Stimulation Studies: A Crossover Trial

ObjectiveTo evaluate whether and to which extent skin redness (erythema) affects investigator blinding in transcranial direct current stimulation (tDCS) trials. Material and MethodsTwenty-six volunteers received sham and active tDCS, which was applied with saline-soaked sponges of different thicknesses. High-resolution skin images, taken before and 5, 15, and 30 min after stimulation, were randomized and presented to experienced raters who evaluated erythema intensity and judged on the likelihood of stimulation condition (sham vs. active). In addition, semi-automated image processing generated probability heatmaps and surface area coverage of erythema. Adverse events were also collected. ResultsErythema was present, but less intense in sham compared to active groups. Erythema intensity was inversely and directly associated to correct sham and active stimulation group allocation, respectively. Our image analyses found that erythema also occurs after sham and its distribution is homogenous below electrodes. Tingling frequency was higher using thin compared to thick sponges, whereas erythema was more intense under thick sponges. ConclusionsOptimal investigator blinding is achieved when erythema after tDCS is mild. Erythema distribution under the electrode is patchy, occurs after sham tDCS and varies according to sponge thickness. We discuss methods to address skin erythema-related tDCS unblinding.

Palavras-chave

Adverse effects, blinding, computer modeling, erythema, randomized-controlled trials, skin redness, transcranial direct current stimulation

URI

https://observatorio.fm.usp.br/handle/OPI/19921

Referências

Ambrus GG, 2012, BRAIN STIMUL, V5, P499, DOI 10.1016/j.brs.2011.12.001
Ambrus GG, 2011, CLIN NEUROPHYSIOL, V122, P803, DOI 10.1016/j.clinph.2010.08.023
Brunoni AR, 2012, BRAIN STIMUL, V5, P175, DOI 10.1016/j.brs.2011.03.002
Brunoni AR, 2011, INT J NEUROPSYCHOPH, V14, P1133, DOI 10.1017/S1461145710001690
Dundas JE, 2007, CLIN NEUROPHYSIOL, V118, P1166, DOI 10.1016/j.clinph.2007.01.010
Ferrell WR, 2004, FUND CLIN PHARMACOL, V18, P195, DOI 10.1111/j.1472-8206.2004.00218.x
FITZPATRICK TB, 1988, ARCH DERMATOL, V124, P869, DOI 10.1001/archderm.124.6.869
Gandiga PC, 2006, CLIN NEUROPHYSIOL, V117, P845, DOI 10.1016/j.clinph.2005.12.003
Guarienti F, 2015, NEUROMODULATION, V18, P261, DOI 10.1111/ner.12230
Guleyupoglu Berkan, 2014, Front Neuroeng, V7, P28, DOI 10.3389/fneng.2014.00028
Kessler SK, 2012, BRAIN STIMUL, V5, P155, DOI 10.1016/j.brs.2011.02.007
Khadka N, 2015, BRAIN STIMUL, V8, P150, DOI 10.1016/j.brs.2014.10.004
Miranda PC, 2006, CLIN NEUROPHYSIOL, V117, P1623, DOI 10.1016/j.clinph.2006.04.009
O'Connell NE, 2012, PLOS ONE, V7, DOI 10.1371/journal.pone.0047514
Palm U, 2013, BRAIN STIMUL, V6, P690, DOI 10.1016/j.brs.2013.01.005
Poreisz C, 2007, BRAIN RES BULL, V72, P208, DOI 10.1016/j.brainresbull.2007.01.004
Portney LG, 2008, FDN CLIN RES APPL PR
Saturnino GB, 2015, NEUROIMAGE, V120, P25, DOI 10.1016/j.neuroimage.2015.06.067
Tortella Gabriel, 2015, World J Psychiatry, V5, P88, DOI 10.5498/wjp.v5.i1.88
Turi Z, 2014, BRAIN STIMUL, V7, P460, DOI 10.1016/j.brs.2014.01.059
Wagner T, 2007, NEUROIMAGE, V35, P1113, DOI 10.1016/j.neuroimage.2007.01.027
Woods AJ, 2016, CLIN NEUROPHYSIOL, V127, P1031, DOI 10.1016/j.clinph.2015.11.012

Coleções

Artigos e Materiais de Revistas Científicas - FM/MCM
Artigos e Materiais de Revistas Científicas - HC/InCor
Artigos e Materiais de Revistas Científicas - HC/IPq
Artigos e Materiais de Revistas Científicas - LIM/13
Artigos e Materiais de Revistas Científicas - LIM/20
Artigos e Materiais de Revistas Científicas - LIM/27

Página do item completo