rethinking clinical trials of transcranial direct current stimulation participant and assessor blinding is inadequate at intensities of 2ma反思经颅直流电刺激的临床试验参与者和评估员致盲马2的强度是不够的.pdfVIP

Rethinking Clinical Trials of Transcranial Direct Current Stimulation: Participant and Assessor Blinding Is Inadequate at Intensities of 2mA 1 1 2 3 4 Neil E. O’Connell *, John Cossar , Louise Marston , Benedict M. Wand , David Bunce , G. Lorimer Moseley5, Lorraine H. De Souza1 1 Centre for Research in Rehabilitation, School of Health Sciences and Social Care, Brunel University, London, United Kingdom, 2 Research Department of Primary Care Population Health, University College London, London, United Kingdom, 3 School of Physiotherapy, University of Notre Dame Australia, Fremantle, Australia, 4 Centre for Cognition and Neuroimaging, Brunel University, London, United Kingdom, 5 Sansom Institute for Health Research, University of South Australia, Adelaide, Neuroscience Research Australia, Sydney, Australia Abstract Background: 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. ¨ Methods: A randomised double blind crossover trial. 100 tDCS-naıve 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