Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2mA.
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重新思考经颅直流刺激的临床试验：参与者和评估者的盲目性在2MA的强度下不足。
DOI：
10.1371/journal.pone.0047514
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发表时间：
2012
期刊：
影响因子：
3.7
通讯作者：
De Souza LH
中科院分区：
文献类型：
--
作者：
O'Connell NE;Cossar J;Marston L;Wand BM;Bunce D;Moseley GL;De Souza LH
许多经颅直流电刺激（tDCS）的双盲临床试验使用2 mA的刺激强度，尽管在这些条件下盲法尚未得到正式验证。本研究的目的是检验假2 mA tDCS实现有效设盲的假设。随机双盲交叉试验。100名未接受过tDCS的健康志愿者被错误地告知他们正在参加一项tDCS对单词记忆的试验。与会者分别参加了两次会议。在每次会话中，他们完成了一个单词记忆任务，然后以2 mA刺激强度接受主动或假tDCS（顺序随机化）20分钟，然后重复单词记忆任务。然后，他们判断自己是否相信自己受到了积极的刺激，并对自己的判断进行了信心评估。设盲评估者记录刺激后在电极部位观察到红色标记的时间。在2 mA下的tDCS没有被有效地盲化。也就是说，参与者在第一次会议（一致性水平（κ）为0.28，95%置信区间（CI）为0.09至0.47，p = 0.005）和第二次会议（κ = 0.77，95%CI为0.64至0.90，p =<0.001）时正确判断的刺激条件大于预期，表明参与者盲法不充分。 主动刺激后参考电极部位的发红明显多于假刺激（第一阶段，κ = 0.512，95%CI 0.363至0.66，p<0.001;第二阶段，κ = 0.677，95%CI 0.534至0.82），表明评估者设盲不充分。 我们的研究结果表明，在强度为2 mA的tDCS研究中设盲是不够的。这些研究的积极结果应谨慎解释。
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. 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. 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. 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.
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影响因子：
7.7
作者：
Brunoni, Andre Russowsky;Nitsche, Michael A.;Bolognini, Nadia;Bikson, Marom;Wagner, Tim;Merabet, Lotfi;Edwards, Dylan J.;Valero-Cabre, Antoni;Rotenberg, Alexander;Pascual-Leone, Alvaro;Ferrucci, Roberta;Priori, Alberto;Boggio, Paulo Sergio;Fregni, Felipe
通讯作者：
Fregni, Felipe
DOI：
10.1016/j.ejpain.2009.01.002
发表时间：
2010-01
期刊：
European journal of pain (London, England)
影响因子：
--
作者：
Klatzkin RR;Mechlin B;Girdler SS
通讯作者：
Girdler SS
DOI：
10.1017/s1461145709990411
发表时间：
2010-02-01
影响因子：
4.8
作者：
Loo, Colleen K.;Sachdev, Perminder;Mitchell, Philip
通讯作者：
Mitchell, Philip
影响因子：
4
作者：
Mori, Francesco;Codeca, Claudia;Centonze, Diego
通讯作者：
Centonze, Diego
影响因子：
10.5
作者：
Loo, Colleen K.;Alonzo, Angelo;Sachdev, Perminder
通讯作者：
Sachdev, Perminder