Andre Russowsky Brunoni1, Michael A Nitsche2, Nadia Bolognini3, Marom Bikson4, Tim Wagner5, Lotfi Merabet6, Dylan J Edwards7, Antoni Valero-Cabre8, Alexander Rotenberg9, Alvaro Pascual-Leone10, Roberta Ferrucci11, Alberto Priori11, Paulo Sergio Boggio12, Felipe Fregni13. 1. Department of Neurosciences and Behavior, Institute of Psychology, University of São Paulo, São Paulo, Brazil. 2. Department of Clinical Neurophysiology, Georg-August University, Goettingen, Germany. 3. Department of Psychology, University of Milano-Bicocca, Milan, Italy; Neuropsychological Laboratory, IRCCS Instituto Auxologico Italiano, Milan, Italy. 4. The City College of City University of New York, New York, New York. 5. Massachusetts Institute of Technology, Boston, Massachusetts. 6. Massachusets Eye and Ear Infirmary, Harvard University, Boston, Massachusetts. 7. Burke Medical Research Institute, White Plains, New York. 8. Boston University School of Medicine, Boston, Massachusetts. 9. Department of Neurology, Children's Hospital, Harvard Medical School, Boston, Massachusetts. 10. Berenson-Allen Center for Non-invasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts. 11. Centro Clinico per la Neurostimolazione, le Neurotecnologie ed i Disordini del Movimento, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Università degli Studi di Milano Dipartimento di Scienze Neurologiche, Milan, Italy. 12. Social and Cognitive Neuroscience Laboratory and Developmental Disorders Program, Center for Health and Biological Sciences, Mackenzie Prebyterian University, Sao Paulo, Brazil. 13. Laboratory of Neuromodulation, Department of Physical Medicine and Rehabilitation, Spaulding Rehabilitation Hospital and Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts. Electronic address: fregni.felipe@mgh.harvard.edu.
Abstract
BACKGROUND: Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past 10 years, tDCS physiologic mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodologic, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. METHODS: We convened a workgroup of researchers in the field to review, discuss, and provide updates and key challenges of tDCS use in clinical research. MAIN FINDINGS/DISCUSSION: We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (1) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (2) methodologic aspects related to the clinical research of tDCS as divided according to study phase (ie, preclinical, phase I, phase II, and phase III studies); (3) ethical and regulatory concerns; and (4) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS.
BACKGROUND: Transcranial direct current stimulation (tDCS) is a neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity. In the past 10 years, tDCS physiologic mechanisms of action have been intensively investigated giving support for the investigation of its applications in clinical neuropsychiatry and rehabilitation. However, new methodologic, ethical, and regulatory issues emerge when translating the findings of preclinical and phase I studies into phase II and III clinical studies. The aim of this comprehensive review is to discuss the key challenges of this process and possible methods to address them. METHODS: We convened a workgroup of researchers in the field to review, discuss, and provide updates and key challenges of tDCS use in clinical research. MAIN FINDINGS/DISCUSSION: We reviewed several basic and clinical studies in the field and identified potential limitations, taking into account the particularities of the technique. We review and discuss the findings into four topics: (1) mechanisms of action of tDCS, parameters of use and computer-based human brain modeling investigating electric current fields and magnitude induced by tDCS; (2) methodologic aspects related to the clinical research of tDCS as divided according to study phase (ie, preclinical, phase I, phase II, and phase III studies); (3) ethical and regulatory concerns; and (4) future directions regarding novel approaches, novel devices, and future studies involving tDCS. Finally, we propose some alternative methods to facilitate clinical research on tDCS.
Authors: Nikolaus Kriegeskorte; Martin A Lindquist; Thomas E Nichols; Russell A Poldrack; Edward Vul Journal: J Cereb Blood Flow Metab Date: 2010-06-23 Impact factor: 6.200
Authors: Felipe Fregni; Paulo S Boggio; Michael A Nitsche; Marco A Marcolin; Sergio P Rigonatti; Alvaro Pascual-Leone Journal: Bipolar Disord Date: 2006-04 Impact factor: 6.744
Authors: A C Merzagora; G Foffani; I Panyavin; L Mordillo-Mateos; J Aguilar; B Onaral; A Oliviero Journal: Neuroimage Date: 2009-10-21 Impact factor: 6.556
Authors: Charlotte J Stagg; Jonathan G Best; Mary C Stephenson; Jacinta O'Shea; Marzena Wylezinska; Z Tamas Kincses; Peter G Morris; Paul M Matthews; Heidi Johansen-Berg Journal: J Neurosci Date: 2009-04-22 Impact factor: 6.167
Authors: Adam J Woods; Ronald Cohen; Michael Marsiske; Gene E Alexander; Sara J Czaja; Samuel Wu Journal: Contemp Clin Trials Date: 2017-12-05 Impact factor: 2.226
Authors: Matthew D Johnson; Hubert H Lim; Theoden I Netoff; Allison T Connolly; Nessa Johnson; Abhrajeet Roy; Abbey Holt; Kelvin O Lim; James R Carey; Jerrold L Vitek; Bin He Journal: IEEE Trans Biomed Eng Date: 2013-02-01 Impact factor: 4.538
Authors: L Joos; A E Goudriaan; L Schmaal; N A J De Witte; W Van den Brink; B G C Sabbe; G Dom Journal: Psychopharmacology (Berl) Date: 2012-10-25 Impact factor: 4.530