Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials
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Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials. / Palm, Ulrich; Reisinger, Eva; Keeser, Daniel; Kuo, Min-Fang; Pogarell, Oliver; Leicht, Gregor; Mulert, Christoph; Nitsche, Michael A; Padberg, Frank.
in: BRAIN STIMUL, Jahrgang 6, Nr. 4, 01.07.2013, S. 690-5.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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TY - JOUR
T1 - Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials
AU - Palm, Ulrich
AU - Reisinger, Eva
AU - Keeser, Daniel
AU - Kuo, Min-Fang
AU - Pogarell, Oliver
AU - Leicht, Gregor
AU - Mulert, Christoph
AU - Nitsche, Michael A
AU - Padberg, Frank
N1 - Copyright © 2013 Elsevier Inc. All rights reserved.
PY - 2013/7/1
Y1 - 2013/7/1
N2 - 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.
AB - 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.
KW - Adult
KW - Double-Blind Method
KW - Electric Stimulation Therapy
KW - Female
KW - Humans
KW - Male
KW - Placebos
KW - Randomized Controlled Trials as Topic
U2 - 10.1016/j.brs.2013.01.005
DO - 10.1016/j.brs.2013.01.005
M3 - SCORING: Journal article
C2 - 23415938
VL - 6
SP - 690
EP - 695
JO - BRAIN STIMUL
JF - BRAIN STIMUL
SN - 1935-861X
IS - 4
ER -
