Evaluation of sham transcranial direct current stimulation for randomized, placebo-controlled clinical trials

Brain Stimulation

Volumn 6, Issue 4, 2013, Pages 690-695

  Palm, Ulrich ^a   Reisinger, Eva ^a   Keeser, Daniel ^a,b   Kuo, Min Fang ^c   Pogarell, Oliver ^a   Leicht, Gregor ^a,d   Mulert, Christoph ^a,d   Nitsche, Michael A ^c   Padberg, Frank ^a  

^a LUDWIG MAXIMILIANS UNIVERSITY   (Germany)

^b UNIVERSITY OF MUNICH   (Germany)

^c UNIVERSITY OF GÖTTINGEN   (Germany)

^d UNIVERSITY MEDICAL CENTER HAMBURG EPPENDORF   (Germany)

Author keywords

Blinding; Sham stimulation; tDCS

Indexed keywords

ADULT; ARTICLE; BURNING SENSATION; CONTROLLED CLINICAL TRIAL (TOPIC); CONTROLLED STUDY; DOUBLE BLIND PROCEDURE (TOPIC); ERYTHEMA; FEMALE; HEADACHE; HUMAN; HUMAN EXPERIMENT; INTERMETHOD COMPARISON; MALE; NERVOUSNESS; NORMAL HUMAN; PAIN; PREFRONTAL CORTEX; PRIORITY JOURNAL; PRURITUS; RANDOMIZED CONTROLLED TRIAL (TOPIC); SHAM PROCEDURE; SKIN TINGLING; TRANSCRANIAL DIRECT CURRENT STIMULATION;

BLINDING; SHAM STIMULATION; TDCS;

ADULT; DOUBLE-BLIND METHOD; ELECTRIC STIMULATION THERAPY; FEMALE; HUMANS; MALE; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC;

EID: 84879921797     PISSN: 1935861X     EISSN: 18764754     Source Type: Journal    
DOI: 10.1016/j.brs.2013.01.005     Document Type: Article

References (35)

1. M.A. Nitsche, L.G. Cohen, E.M. Wassermann, A. Priori, N. Lang, and A. Antal Transcranial direct current stimulation: state of the art 2008 Brain Stimul 1 2008 206 223
2. M.A. Nitsche, and W. Paulus Transcranial direct current stimulation-update 2011 Restor Neurol Neurosci 29 2011 463 492
3. U.G. Kalu, C.E. Sexton, C.K. Loo, and K.P. Ebmeier Transcranial direct current stimulation in the treatment of major depression: a meta-analysis Psychol Med 42 2012 1791 1800
4. M.B. Iyer, U. Mattu, J. Grafman, M. Lomarev, S. Sato, and E.M. Wassermann Safety and cognitive effect of frontal DC brain polarization in healthy individuals Neurology 64 2005 872 875
5. P.S. Boggio, R. Ferrucci, S.P. Rigonatti, P. Covre, M.A. Nitsche, and A. Pascual-Leone Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease J Neurol Sci 249 2006 31 38
6. P.S. Boggio, F. Bermpohl, A.O. Vergara, A.L. Muniz, F.H. Nahas, and P.B. Leme Go-no-go task performance improvement after anodal transcranial DC stimulation of the left dorsolateral prefrontal cortex in major depression J Affect Disord 101 2007 91 98
7. P.S. Boggio, S.P. Rigonatti, R.B. Ribeiro, M.L. Myczkowski, M.A. Nitsche, and A. Pascual-Leone A randomized, double-blind clinical trial on the efficacy of cortical direct current stimulation for the treatment of major depression Int J Neuropsychopharmacol 11 2008 249 254
8. S. Fecteau, A. Pascual-Leone, D.H. Zald, P. Liguori, H. Théoret, and P.S. Boggio Activation of prefrontal cortex by transcranial direct current stimulation reduces appetite for risk during ambiguous decision making J Neurosci 27 2007 6212 6218
9. F. Fregni, P.S. Boggio, M.A. Nitsche, F. Bermpohl, A. Antal, and E. Feredoes Anodal transcranial direct current stimulation of prefrontal cortex enhances working memory Exp Brain Res 166 2005 23 30
10. F. Fregni, R. Gimenes, A.C. Valle, M.J. Ferreira, R.R. Rocha, and L. Natalle A randomized, sham-controlled, proof of principle study of transcranial direct current stimulation for the treatment of pain of fibromyalgia Arthrit Rheum 54 2006 3988 3998
11. F. Fregni, P.S. Boggio, M.A. Nitsche, M.A. Marcolin, S.P. Rigonatti, and A. Pascual-Leone Treatment of major depression with transcranial direct current stimulation Bipolar Disord 8 2006 203 204
12. F. Fregni, P.S. Boggio, M.A. Nitsche, S.P. Rigonatti, and A. Pascual-Leone Cognitive effects of repeated sessions of transcranial direct current stimulation in patients with depression Depress Anxiety 23 2006 482 484
13. F. Fregni, P.S. Boggio, M.C. Lima, M.J. Ferreira, T. Wagner, and S.P. Rigonatti A sham-controlled, phase II trial of transcranial direct current stimulation for the treatment of central pain in traumatic spinal cord injury Pain 122 2006 197 209
14. P.C. Gandiga, F.C. Hummel, and L.G. Cohen Transcranial DC stimulation (tDCS): a tool for double-blind sham-controlled clinical studies in brain stimulation Clin Neurophysiol 117 2006 845 850
15. C. Poreisz, K. Boros, A. Natal, and W. Paulus Safety aspects of transcranial direct current stimulation concerning healthy subjects and patients Brain Res Bull 72 2007 208 214
16. C.K. Loo, P. Sachdev, D. Martin, M. Pigot, A. Alonzo, and G.S. Malhi A double-blind, sham controlled trial of transcranial direct current stimulation for the treatment of depression Int J Neuropsychopharmacol 13 2010 61 69
17. R. Ferrucci, M. Bortolomasi, M. Vergari, L. Tadini, B. Salvoro, and M. Giacopuzzi Transcranial direct current stimulation in severe, drug-resistant depression J Affect Disord 118 2009 215 219
18. U. Palm, C. Schiller, Z. Fintescu, M. Obermeier, D. Keeser, and E. Reisinger Transcranial direct current stimulation in treatment resistant depression: a randomized double-blind, placebo-controlled study Brain Stimul 5 2012 242 251
19. H.R. Siebner, N. Lang, V. Rizzo, M.A. Nitsche, W. Paulus, and R.N. Lemon Preconditioning of low-frequency repetitive transcranial magnetic stimulation with transcranial direct current stimulation: evidence for homeostatic plasticity in the human motor cortex J Neurosci 24 2004 3379 3385
20. N. Lang, H.R. Siebner, N.S. Ward, L. Lee, M.A. Nitsche, and W. Paulus How does transcranial direct current stimulation of the primary motor cortex alter regional neuronal activity in the human brain? Eur J Neurosci 22 2005 495 504
21. A. Rogalewski, C. Breitenstein, M.A. Nitsche, W. Paulus, and S. Knecht Transcranial direct current stimulation disrupts tactile perception Eur J Neurosci 20 2004 313 316
22. N.E. O'Connell, J. Cossar, L. Marston, B.M. Wand, D. Bunce, and G.L. Moseley Rethinking clinical trials of transcranial direct current stimulation: participant and assessor blinding is inadequate at intensities of 2 mA PLoS One 7 2012 e47514
23. J.E. Dundas, G.W. Thickbroom, and F.L. Mastaglia Perception comfort during transcranial direct current stimulation Clin Neurophysiol 118 2007 1166 1170
24. G.G. Ambrus, H. Al-Moyed, L. Chaieb, L. Sarp, A. Antal, and W. Paulus The fade-in - short stimulation - fade out approach to sham tDCS - reliable at 1 mA for naïve and experienced subjects, but not investigators Brain Stimul 5 2012 499 504
25. G.G. Ambrus, W. Paulus, and A. Antal Cutaneous perception thresholds of electrical stimulation methods: comparison of tDCS and tRNS Clin Neurophysiol 121 2010 1908 1914
26. E.M. Wassermann, and J. Grafman Recharging cognition with DC brain polarization Trends Cogn Sci 9 2005 503 505
27. A. Antal, D. Terney, S. Kühnl, and W. Paulus Anodal transcranial direct current stimulation of the motor cortex ameliorates chronic pain and reduces short intracortical inhibition J Pain Symptom Manage 39 2010 890 903
28. J.L. McFadden, J.J. Borckardt, M.S. George, and W. Beam Reducing procedural pain and discomfort associated with transcranial direct current stimulation Brain Stimul 4 2011 38 42
29. D.L. Sackett Commentary: measuring the success of blinding RCTs: don't, must, can't or needn't? Int J Epidemiol 36 2007 664 665
30. A.R. Brunoni, and F. Fregni Clinical trial design in non-invasive brain stimulation psychiatric research Int J Methods Psychiatr Res 20 2011 e19 e30
31. S. Durand, B. Fromy, P. Bouyé, J.L. Saumet, and P. Abraham Vasodilatation in response to repeated anodal current application in the human skin relies on aspirin-sensitive mechanisms J Physiol 540 2002 261 269
32. D. Ferguson, K.C. Glass, D. Waring, and S. Shapiro Turning a blind eye: the success of blinding reported in a random sample of randomized, placebo controlled trials BMJ 328 2004 432
33. D.G. Altman, K.F. Schulz, and D. Moher Testing the success of blinding and the CONSORT statement BMJ 328 2004 1135
34. S.J. Senn Authors have blinkered view of blinding BMJ 328 2004 1135
35. D.L. Sackett Why we don't test for blindness at the end of our trials BMJ 328 2004 1136