Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials.
Brain Stimul
; 6(4): 690-5, 2013 Jul.
Article
em En
| MEDLINE
| ID: mdl-23415938
ABSTRACT
BACKGROUND:
Transcranial direct current stimulation (tDCS) has been investigated as therapeutic intervention in various psychiatric and neurologic disorders. As placebo responses to technical interventions may be pronounced in many clinical conditions, it is important to thoroughly develop placebo conditions which meet the requirements for application in randomized double-blind controlled trials.OBJECTIVE:
The two-part experiment reported here aims at evaluating a new sham tDCS condition in healthy subjects and device operators. Sham or active tDCS is delivered after entering a number code to the device and allows blinding of the operator before and during tDCS. The sham mode has no short stimulation period.METHODS:
The experimental sequence was as follows 1) Evaluation of successful blinding by comparing placebo to active stimulation at prefrontal sites based on the rating of subjects undergoing tDCS, 2) Evaluation of successful blinding by comparing placebo to active stimulation at prefrontal sites based on the operator/observer ratings.RESULTS:
Subjects were not able to distinguish between active and sham tDCS for prefrontal stimulation. Overall there was no relevant discomfort and tDCS was well tolerated. Operators/observers were able to identify sham stimulation based on skin reddening after active, but not after sham tDCS.CONCLUSIONS:
The tDCS sham condition investigated here may be suitable for placebo-controlled trials keeping subjects blind to treatment conditions. However, operators can easily be aware of the condition applied and they should not get involved in rating outcome measures during the course of high standard placebo-controlled trials.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Placebos
/
Ensaios Clínicos Controlados Aleatórios como Assunto
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Terapia por Estimulação Elétrica
Tipo de estudo:
Clinical_trials
/
Evaluation_studies
Limite:
Adult
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Female
/
Humans
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Male
Idioma:
En
Revista:
Brain Stimul
Ano de publicação:
2013
Tipo de documento:
Article