Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines
•The application of low intensity TES in humans appears to be safe.•The profile of AEs in terms of frequency, magnitude and type is comparable in different populations.•Structured checklists and interviews as recommended procedures are provided in this paper. Low intensity transcranial electrical st...
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| Published in | Clinical neurophysiology Vol. 128; no. 9; pp. 1774 - 1809 |
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| Main Authors | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Netherlands
Elsevier B.V
01.09.2017
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| Subjects | |
| Online Access | Get full text |
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| Abstract | •The application of low intensity TES in humans appears to be safe.•The profile of AEs in terms of frequency, magnitude and type is comparable in different populations.•Structured checklists and interviews as recommended procedures are provided in this paper.
Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2mA and during tACS at higher peak-to-peak intensities above 2mA.
The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues.
Safety is established for low-intensity ‘conventional’ TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe.
In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6–7, 2016 and were refined thereafter by email correspondence. |
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| AbstractList | Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m
that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence. Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence.Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1-2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity 'conventional' TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3-13A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6-7, 2016 and were refined thereafter by email correspondence. Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2 mA and during tACS at higher peak-to-peak intensities above 2 mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4 mA, up to 60 min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13 A/m 2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10 mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6–7, 2016 and were refined thereafter by email correspondence. Highlights • The application of low intensity TES in humans appears to be safe. • The profile of AEs in terms of frequency, magnitude and type is comparable in different populations. • Structured checklists and interviews as recommended procedures are provided in this paper. •The application of low intensity TES in humans appears to be safe.•The profile of AEs in terms of frequency, magnitude and type is comparable in different populations.•Structured checklists and interviews as recommended procedures are provided in this paper. Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current Stimulation (tsDCS), transcranial alternating current (tACS), and transcranial random noise (tRNS) stimulation or their combinations, appears to be safe. No serious adverse events (SAEs) have been reported so far in over 18,000 sessions administered to healthy subjects, neurological and psychiatric patients, as summarized here. Moderate adverse events (AEs), as defined by the necessity to intervene, are rare, and include skin burns with tDCS due to suboptimal electrode-skin contact. Very rarely mania or hypomania was induced in patients with depression (11 documented cases), yet a causal relationship is difficult to prove because of the low incidence rate and limited numbers of subjects in controlled trials. Mild AEs (MAEs) include headache and fatigue following stimulation as well as prickling and burning sensations occurring during tDCS at peak-to-baseline intensities of 1–2mA and during tACS at higher peak-to-peak intensities above 2mA. The prevalence of published AEs is different in studies specifically assessing AEs vs. those not assessing them, being higher in the former. AEs are frequently reported by individuals receiving placebo stimulation. The profile of AEs in terms of frequency, magnitude and type is comparable in healthy and clinical populations, and this is also the case for more vulnerable populations, such as children, elderly persons, or pregnant women. Combined interventions (e.g., co-application of drugs, electrophysiological measurements, neuroimaging) were not associated with further safety issues. Safety is established for low-intensity ‘conventional’ TES defined as <4mA, up to 60min duration per day. Animal studies and modeling evidence indicate that brain injury could occur at predicted current densities in the brain of 6.3–13A/m2 that are over an order of magnitude above those produced by tDCS in humans. Using AC stimulation fewer AEs were reported compared to DC. In specific paradigms with amplitudes of up to 10mA, frequencies in the kHz range appear to be safe. In this paper we provide structured interviews and recommend their use in future controlled studies, in particular when trying to extend the parameters applied. We also discuss recent regulatory issues, reporting practices and ethical issues. These recommendations achieved consensus in a meeting, which took place in Göttingen, Germany, on September 6–7, 2016 and were refined thereafter by email correspondence. |
| Author | McCaig, C.D. Priori, A. Rothwell, J. Alekseichuk, I. Dowthwaite, G. Wexler, A. Ellrich, J. Paulus, W. Chen, R. Ziemann, U. Hummel, F.C. Loo, C.K. Ruffini, G. George, M.S. Brunoni, A.R. Pascual-Leone, A. Cohen, L.G. Liebetanz, D. Brockmöller, J. Padberg, F. Moliadze, V. Miniussi, C. Nitsche, M.A. Hallett, M. Haueisen, J. Ugawa, Y. Flöel, A. Schellhorn, K. Rossini, P.M. Poppendieck, W. Rossi, S. Nowak, R. Siebner, H.R. Antal, A. Rueger, M.A. Bikson, M. Herrmann, C.S. Miranda, P.C. Lefaucheur, J.P. Fregni, F. Hamilton, R. |
| AuthorAffiliation | r Defitech Chair of Clinical Neuroengineering, Clinique Romande de Réadaptation, Swiss Federal Institute of Technology (EPFL Valais), Sion, Switzerland z Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany n Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA o Institute of Biomedical Engineering and Informatics, Technische Universität Ilmenau, Germany ap Department of Science, Technology & Society, Massachusetts Institute of Technology, Cambridge, MA, USA j EBS Technologies GmbH, Europarc Dreilinden, Germany a Department of Clinical Neurophysiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany p Experimental Psychology Lab, Department of Psychology, European Medical School, Carl von Ossietzky Universität, Oldenburg, Germany h Department of Health Science and Technology, Aalborg University, Aalborg, Denmark ab Neuroelectrics, Barcelona, Spain c Department of Cli |
| AuthorAffiliation_xml | – name: a Department of Clinical Neurophysiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany – name: f Human Cortical Physiology and Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke NIH, Bethesda, USA – name: af Center for Neurotechnology and Experimental Brain Therapeutich, Department of Health Sciences, University of Milan Italy; Deparment of Clinical Neurology, University Hospital Asst Santi Paolo E Carlo, Milan, Italy – name: t School of Psychiatry & Black Dog Institute, University of New South Wales, Sydney, Australia – name: ah Area of Neuroscience, Institute of Neurology, University Clinic A. Gemelli, Catholic University, Rome, Italy – name: m Brain Stimulation Division, Medical University of South Carolina, and Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA – name: u Institute of Medical Sciences, University of Aberdeen, Aberdeen, Scotland, UK – name: ak neuroCare Group GmbH, Munich, Germany – name: k Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie, Greifswald, Germany – name: s Department of Physiology, Henri Mondor Hospital, Assistance Publique – Hôpitaux de Paris, and EA 4391, Nerve Excitability and Therapeutic Team (ENT), Faculty of Medicine, Paris Est Créteil University, Créteil, France – name: ar Human Motor Control Section, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD, USA – name: n Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA – name: am Department of Neurology, Copenhagen University Hospital Bispebjerg, Copenhagen, Denmark – name: ag Department of Medicine, Surgery and Neuroscience, Human Physiology Section and Neurology and Clinical Neurophysiology Section, Brain Investigation & Neuromodulation Lab, University of Siena, Italy – name: e Division of Neurology, Department of Medicine, University of Toronto and Krembil Research Institute, Toronto, Ontario, Canada – name: l Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA – name: x Institute of Biophysics and Biomedical Engineering, Faculdade de Ciências, Universidade de Lisboa, Lisboa, Portugal – name: ab Neuroelectrics, Barcelona, Spain – name: o Institute of Biomedical Engineering and Informatics, Technische Universität Ilmenau, Germany – name: aq Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany – name: i Institute of Physiology and Pathophysiology, University of Erlangen-Nürnberg, Erlangen, Germany – name: d Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27) and Interdisciplinary Center for Applied Neuromodulation University Hospital, University of São Paulo, São Paulo, Brazil – name: b Department of Biomedical Engineering, The City College of New York, New York, USA – name: g The Magstim Company, Whitland, UK – name: q Defitech Chair of Clinical Neuroengineering, Centre of Neuroprosthetics (CNP) and Brain Mind Institute, Swiss Federal Institute of Technology (EPFL), Geneva, Switzerland – name: an Department of Neurology, Fukushima Medical University, Fukushima, Japan – name: ap Department of Science, Technology & Society, Massachusetts Institute of Technology, Cambridge, MA, USA – name: z Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany – name: h Department of Health Science and Technology, Aalborg University, Aalborg, Denmark – name: ac Department of Psychiatry and Psychotherapy, Munich Center for Brain Stimulation, Ludwig-Maximilian University Munich, Germany – name: p Experimental Psychology Lab, Department of Psychology, European Medical School, Carl von Ossietzky Universität, Oldenburg, Germany – name: y Institute of Medical Psychology and Medical Sociology, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Christian-Albrechts-University, Kiel, Germany – name: ao Fukushima Global Medical Science Center, Advanced Clinical Research Center, Fukushima Medical University, Japan – name: j EBS Technologies GmbH, Europarc Dreilinden, Germany – name: aa Department of Neurology, University Hospital Bergmannsheil, Bochum, Germany – name: ai UCL Institute of Neurology, London, UK – name: aj Department of Neurology, University Hospital of Cologne, Germany – name: al Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark – name: ae Department of Information Technology, Mannheim University of Applied Sciences, Mannheim, Germany – name: v Center for Mind/Brain Sciences CIMeC, University of Trento, Rovereto, Italy – name: ad Division of Cognitive Neurology, Harvard Medical Center and Berenson-Allen Center for Noninvasive Brain Stimulation at Beth Israel Deaconess Medical Center, Boston, USA – name: r Defitech Chair of Clinical Neuroengineering, Clinique Romande de Réadaptation, Swiss Federal Institute of Technology (EPFL Valais), Sion, Switzerland – name: c Department of Clinical Pharmacology, University Medical Center Goettingen, Germany – name: w Cognitive Neuroscience Section, IRCCS Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy |
| Author_xml | – sequence: 1 givenname: A. surname: Antal fullname: Antal, A. email: AAntal@gwdg.de organization: Department of Clinical Neurophysiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany – sequence: 2 givenname: I. surname: Alekseichuk fullname: Alekseichuk, I. organization: Department of Clinical Neurophysiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany – sequence: 3 givenname: M. surname: Bikson fullname: Bikson, M. organization: Department of Biomedical Engineering, The City College of New York, New York, USA – sequence: 4 givenname: J. surname: Brockmöller fullname: Brockmöller, J. organization: Department of Clinical Pharmacology, University Medical Center Goettingen, Germany – sequence: 5 givenname: A.R. surname: Brunoni fullname: Brunoni, A.R. organization: Service of Interdisciplinary Neuromodulation, Department and Institute of Psychiatry, Laboratory of Neurosciences (LIM-27) and Interdisciplinary Center for Applied Neuromodulation University Hospital, University of São Paulo, São Paulo, Brazil – sequence: 6 givenname: R. surname: Chen fullname: Chen, R. organization: Division of Neurology, Department of Medicine, University of Toronto and Krembil Research Institute, Toronto, Ontario, Canada – sequence: 7 givenname: L.G. surname: Cohen fullname: Cohen, L.G. organization: Human Cortical Physiology and Neurorehabilitation Section, National Institute of Neurological Disorders and Stroke NIH, Bethesda, USA – sequence: 8 givenname: G. surname: Dowthwaite fullname: Dowthwaite, G. organization: The Magstim Company, Whitland, UK – sequence: 9 givenname: J. surname: Ellrich fullname: Ellrich, J. organization: Department of Health Science and Technology, Aalborg University, Aalborg, Denmark – sequence: 10 givenname: A. surname: Flöel fullname: Flöel, A. organization: Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie, Greifswald, Germany – sequence: 11 givenname: F. surname: Fregni fullname: Fregni, F. organization: Spaulding Neuromodulation Center, Spaulding Rehabilitation Hospital, Harvard Medical School, Boston, MA, USA – sequence: 12 givenname: M.S. surname: George fullname: George, M.S. organization: Brain Stimulation Division, Medical University of South Carolina, and Ralph H. Johnson Veterans Affairs Medical Center, Charleston, SC, USA – sequence: 13 givenname: R. surname: Hamilton fullname: Hamilton, R. organization: Department of Neurology, University of Pennsylvania, Philadelphia, PA, USA – sequence: 14 givenname: J. surname: Haueisen fullname: Haueisen, J. organization: Institute of Biomedical Engineering and Informatics, Technische Universität Ilmenau, Germany – sequence: 15 givenname: C.S. surname: Herrmann fullname: Herrmann, C.S. organization: Experimental Psychology Lab, Department of Psychology, European Medical School, Carl von Ossietzky Universität, Oldenburg, Germany – sequence: 16 givenname: F.C. surname: Hummel fullname: Hummel, F.C. organization: Defitech Chair of Clinical Neuroengineering, Centre of Neuroprosthetics (CNP) and Brain Mind Institute, Swiss Federal Institute of Technology (EPFL), Geneva, Switzerland – sequence: 17 givenname: J.P. surname: Lefaucheur fullname: Lefaucheur, J.P. organization: Department of Physiology, Henri Mondor Hospital, Assistance Publique – Hôpitaux de Paris, and EA 4391, Nerve Excitability and Therapeutic Team (ENT), Faculty of Medicine, Paris Est Créteil University, Créteil, France – sequence: 18 givenname: D. surname: Liebetanz fullname: Liebetanz, D. organization: Department of Clinical Neurophysiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany – sequence: 19 givenname: C.K. surname: Loo fullname: Loo, C.K. organization: School of Psychiatry & Black Dog Institute, University of New South Wales, Sydney, Australia – sequence: 20 givenname: C.D. surname: McCaig fullname: McCaig, C.D. organization: Institute of Medical Sciences, University of Aberdeen, Aberdeen, Scotland, UK – sequence: 21 givenname: C. surname: Miniussi fullname: Miniussi, C. organization: Center for Mind/Brain Sciences CIMeC, University of Trento, Rovereto, Italy – sequence: 22 givenname: P.C. surname: Miranda fullname: Miranda, P.C. organization: Institute of Biophysics and Biomedical Engineering, Faculdade de Ciências, Universidade de Lisboa, Lisboa, Portugal – sequence: 23 givenname: V. surname: Moliadze fullname: Moliadze, V. organization: Institute of Medical Psychology and Medical Sociology, University Hospital of Schleswig-Holstein (UKSH), Campus Kiel, Christian-Albrechts-University, Kiel, Germany – sequence: 24 givenname: M.A. surname: Nitsche fullname: Nitsche, M.A. organization: Department of Psychology and Neurosciences, Leibniz Research Centre for Working Environment and Human Factors, Dortmund, Germany – sequence: 25 givenname: R. surname: Nowak fullname: Nowak, R. organization: Neuroelectrics, Barcelona, Spain – sequence: 26 givenname: F. surname: Padberg fullname: Padberg, F. organization: Department of Psychiatry and Psychotherapy, Munich Center for Brain Stimulation, Ludwig-Maximilian University Munich, Germany – sequence: 27 givenname: A. surname: Pascual-Leone fullname: Pascual-Leone, A. organization: Division of Cognitive Neurology, Harvard Medical Center and Berenson-Allen Center for Noninvasive Brain Stimulation at Beth Israel Deaconess Medical Center, Boston, USA – sequence: 28 givenname: W. surname: Poppendieck fullname: Poppendieck, W. organization: Department of Information Technology, Mannheim University of Applied Sciences, Mannheim, Germany – sequence: 29 givenname: A. surname: Priori fullname: Priori, A. organization: Center for Neurotechnology and Experimental Brain Therapeutich, Department of Health Sciences, University of Milan Italy; Deparment of Clinical Neurology, University Hospital Asst Santi Paolo E Carlo, Milan, Italy – sequence: 30 givenname: S. surname: Rossi fullname: Rossi, S. organization: Department of Medicine, Surgery and Neuroscience, Human Physiology Section and Neurology and Clinical Neurophysiology Section, Brain Investigation & Neuromodulation Lab, University of Siena, Italy – sequence: 31 givenname: P.M. surname: Rossini fullname: Rossini, P.M. organization: Area of Neuroscience, Institute of Neurology, University Clinic A. Gemelli, Catholic University, Rome, Italy – sequence: 32 givenname: J. surname: Rothwell fullname: Rothwell, J. organization: UCL Institute of Neurology, London, UK – sequence: 33 givenname: M.A. surname: Rueger fullname: Rueger, M.A. organization: Department of Neurology, University Hospital of Cologne, Germany – sequence: 34 givenname: G. surname: Ruffini fullname: Ruffini, G. organization: Neuroelectrics, Barcelona, Spain – sequence: 35 givenname: K. surname: Schellhorn fullname: Schellhorn, K. organization: neuroCare Group GmbH, Munich, Germany – sequence: 36 givenname: H.R. surname: Siebner fullname: Siebner, H.R. organization: Danish Research Centre for Magnetic Resonance, Centre for Functional and Diagnostic Imaging and Research, Copenhagen University Hospital Hvidovre, Hvidovre, Denmark – sequence: 37 givenname: Y. surname: Ugawa fullname: Ugawa, Y. organization: Department of Neurology, Fukushima Medical University, Fukushima, Japan – sequence: 38 givenname: A. surname: Wexler fullname: Wexler, A. organization: Department of Science, Technology & Society, Massachusetts Institute of Technology, Cambridge, MA, USA – sequence: 39 givenname: U. surname: Ziemann fullname: Ziemann, U. organization: Department of Neurology & Stroke, and Hertie Institute for Clinical Brain Research, University of Tübingen, Tübingen, Germany – sequence: 40 givenname: M. surname: Hallett fullname: Hallett, M. organization: Human Motor Control Section, National Institute of Neurological Disorders and Stroke, NIH, Bethesda, MD, USA – sequence: 41 givenname: W. surname: Paulus fullname: Paulus, W. organization: Department of Clinical Neurophysiology, University Medical Center Göttingen, Georg August University, Göttingen, Germany |
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| Snippet | •The application of low intensity TES in humans appears to be safe.•The profile of AEs in terms of frequency, magnitude and type is comparable in different... Highlights • The application of low intensity TES in humans appears to be safe. • The profile of AEs in terms of frequency, magnitude and type is comparable in... Low intensity transcranial electrical stimulation (TES) in humans, encompassing transcranial direct current (tDCS), transcutaneous spinal Direct Current... |
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| SubjectTerms | Adverse events Animals Brain - physiology Burns, Electric - etiology Burns, Electric - prevention & control Humans Neurology Practice Guidelines as Topic - standards Safety tACS tDCS TES Transcranial Direct Current Stimulation - adverse effects Transcranial Direct Current Stimulation - ethics Transcranial Direct Current Stimulation - standards |
| Title | Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines |
| URI | https://www.clinicalkey.com/#!/content/1-s2.0-S1388245717302122 https://www.clinicalkey.es/playcontent/1-s2.0-S1388245717302122 https://dx.doi.org/10.1016/j.clinph.2017.06.001 https://www.ncbi.nlm.nih.gov/pubmed/28709880 https://www.proquest.com/docview/1920195671 https://pubmed.ncbi.nlm.nih.gov/PMC5985830 |
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