Reducing transcranial direct current stimulation-induced erythema with skin pretreatment: considerations for sham-controlled clinical trials.

Fabiana Guarienti, Wolnei Caumo, Pedro Shiozawa, Quirino Cordeiro, Paulo S Boggio, Isabela M Benseñor, Paulo A Lotufo, Marom Bikson, André R Brunoni

Journal: Neuromodulation : journal of the International Neuromodulation Society 2016;18(4):261-5

PMID: 25209456

Abstract

OBJECTIVES

Transcranial direct current stimulation (tDCS)-induced erythema (skin reddening) has been described as an adverse effect that can harm blinding integrity in sham-controlled designs. To tackle this issue, we investigated whether the use of topical pretreatments could decrease erythema and other adverse effects associated with tDCS.

MATERIALS AND METHODS

Thirty healthy volunteers were recruited, and four interventions were applied 30 min prior to tDCS in a Latin square design: placebo, ketoprofen 2%, hydroxyzine 1%, and lidocaine 5%. TDCS was applied for 30 min (2 mA, anode and cathode over F3 and F4, respectively) in two active sessions with a minimum 1-week interval. The Draize erythema scoring system scale was used to assess erythema intensity; a tDCS questionnaire was used to assess other adverse effects (e.g., tingling, itching, burning sensation, and pain).

RESULTS

We found that ketoprofen (but not hydroxyzine or lidocaine) significantly attenuated tDCS-induced erythema regarding intensity and duration, with a medium effect compared with placebo. Erythema was overall mild, short-lived (lasting 18-24 min after tDCS ending), and more intense under the anode. Subjects with darker skin color also tended to present less intense tDCS-induced erythema. The prevalence of other adverse effects was low and did not differ between dermatological groups.

CONCLUSIONS

Ketoprofen 2% topical pretreatment might be an interesting strategy to reduce tDCS-induced erythema and might be useful for blinding improvement in further sham-controlled tDCS trials.

© 2014 International Neuromodulation Society.

Address: Service of Interdisciplinary Neuromodulation & Interdisciplinary Center for Applied Neuromodulation, Department and Institute of Psychiatry, University Hospital, University of São Paulo, São Paulo, Brazil.; Laboratory of Pain and Neuromodulation, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.; Laboratory of Pain and Neuromodulation, Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.; Service of Interdisciplinary Neuromodulation & Interdisciplinary Center for Applied Neuromodulation, Department and Institute of Psychiatry, University Hospital, University of São Paulo, São Paulo, Brazil.; Laboratory of Clinical Neuromodulation, Santa Casa Medical School, São Paulo, Brazil.; Laboratory of Clinical Neuromodulation, Santa Casa Medical School, São Paulo, Brazil.; Laboratory of Cognitive and Social Neurosciences, Mackenzie Presbyterian University, São Paulo, Brazil.; Service of Interdisciplinary Neuromodulation & Interdisciplinary Center for Applied Neuromodulation, Department and Institute of Psychiatry, University Hospital, University of São Paulo, São Paulo, Brazil.; Department of Biomedical Engineering, City College of New York, City University of New York, New York, NY, USA.
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