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1. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Hummel, Friedhelm Christoph, Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A.R., Chen, R., Cohen, L.G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M.S., Hamilton, R., Haueisen, J., Herrmann, C.S., Lefaucheur, J.P., Liebetanz, D., Loo, C.K., McCaig, C.D., Miniussi, C., Miranda, P.C., Moliadze, V., Nitsche, M.A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P.M., Rothwell, J., Rueger, M.A., Ruffini, G., Schellhorn, K., Siebner, H.R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., and Hummel, Friedhelm Christoph

Abstract

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 t

Published
2018
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2. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Antal, A., Alekseichuk, I., Bikson, M., Brockmoeller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Floeel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Antal, A., Alekseichuk, I., Bikson, M., Brockmoeller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Floeel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., and Paulus, W.

Abstract

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.& para;& para;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.& para;& para;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 Afin(2) that are over an order of m

Published
2017

3. Low intensity transcranial electric stimulation:Safety, ethical, legal regulatory and application guidelines

Author

Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Antal, A., Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., McCaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, P. M., Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., and Paulus, W.

Abstract

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/m2 that are over an order of magnitude abo

Published
2017

4. Low intensity transcranial electric stimulation: Safety, ethical, legal regulatory and application guidelines

Author

Berthoin Antal, Ariane, Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., Mccaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, Paolo Maria, Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Berthoin Antal, A., Rossini, P. M. (ORCID:0000-0003-2665-534X), Berthoin Antal, Ariane, Alekseichuk, I., Bikson, M., Brockmöller, J., Brunoni, A. R., Chen, R., Cohen, L. G., Dowthwaite, G., Ellrich, J., Flöel, A., Fregni, F., George, M. S., Hamilton, R., Haueisen, J., Herrmann, C. S., Hummel, F. C., Lefaucheur, J. P., Liebetanz, D., Loo, C. K., Mccaig, C. D., Miniussi, C., Miranda, P. C., Moliadze, V., Nitsche, M. A., Nowak, R., Padberg, F., Pascual-Leone, A., Poppendieck, W., Priori, A., Rossi, S., Rossini, Paolo Maria, Rothwell, J., Rueger, M. A., Ruffini, G., Schellhorn, K., Siebner, H. R., Ugawa, Y., Wexler, A., Ziemann, U., Hallett, M., Paulus, W., Berthoin Antal, A., and Rossini, P. M. (ORCID:0000-0003-2665-534X)

Abstract

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/m2that are over an order of magnitude above

Published
2017

6. Regenerative interventions in professional football

Author

Meyer, T, Wegmann, M, Poppendieck, W, Fullagar, HHK, Meyer, T, Wegmann, M, Poppendieck, W, and Fullagar, HHK

Abstract

To alleviate acute fatigue after strenuous football training sessions or matches several potentially recovery-enhancing methods and tools are available: cooling/water immersion, sleep, nutrition, active recovery, massage, and other modalities. Although limited scientific evidence is available, there are indications for cooling by cold water immersion and appropriate nutrition to be effective, whereas theoretical reasons suggest the application of active recovery and sleep interventions (take care for sufficient quantity and quality of sleep, employing measures of sleep hygiene) could enhance the recovery process. Even in the absence of solid experimental evidence, the placebo effect of many methods might be worth using as long as relevant side effects can be ruled out. © 2014.

Published
2014

7. Quantification of safe operation conditions for large-area platinum-iridium electrodes in neurostimulation application.

Author

Leusmann E, Abkai C, Tittelbach M, and Poppendieck W

Subjects
Humans, Dielectric Spectroscopy methods, Platinum chemistry, Iridium chemistry, Electrodes
Abstract

Objective: Using electrochemical characterization methods of stimulation electrodes as well as accelerated stimulation examinations, a safe operating field for stimulation is investigated for particularly very large Pt-Ir macroelectrodes in a Laplace configuration., Approach: Traditional methods such as Electrochemical Impedance Spectroscopy, Cyclic Voltammetry and biphasic, charge balanced current pulses were applied on Pt-Ir macroelectrodes in phosphate buffered saline solution to investigate reversible boundaries. These experiments were adapted to approach realistic working conditions., Main Results: Investigating operational conditions close to realistic use cases have shown an anti-correlation between higher scan rates and the occurrence of irreversible reactions. In addition, at higher current pulse amplitudes (>3 mA), the voltage dropping across the phase boundary (Ema and Emc) saturated. The value of the residual voltage depends on the degree of charge balance of the biphasic pulse. Thus, we have been able to detect more dissolved platinum at high residual voltages-objected by mass spectroscopic measurement., Significance: Residual voltage plays a greater role concerning reversibility in prolonged stimulation and charge imbalance of applied biphasic current pulses. The Ema saturation is suggested as a new marker for the occurrence of irreversible reactions which needs further investigation. Current amplitudes of 1 mA for the considered single electrode configuration did not lead to a capacitive voltage saturation nor a considerable dissolution of platinum ions and is thus considered as a safe operation configuration., Competing Interests: The authors have declared that no competing interests exist., (Copyright: © 2024 Leusmann et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)

Published
2024
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8. Blind identification of the spinal cord output in humans with high-density electrode arrays implanted in muscles.

Author

Muceli S, Poppendieck W, Holobar A, Gandevia S, Liebetanz D, and Farina D

Abstract

Invasive electromyography opened a new window to explore motoneuron behavior in vivo. However, the technique is limited by the small fraction of active motoneurons that can be concurrently detected, precluding a population analysis in natural tasks. Here, we developed a high-density intramuscular electrode for in vivo human recordings along with a fully automatic methodology that could detect the discharges of action potentials of up to 67 concurrently active motoneurons with 99% accuracy. These data revealed that motoneurons of the same pool receive common synaptic input at frequencies up to 75 Hz and that late-recruited motoneurons inhibit the discharges of those recruited earlier. These results constitute an important step in the population coding analysis of the human motor system in vivo.

Published
2022
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9. Accurate and representative decoding of the neural drive to muscles in humans with multi-channel intramuscular thin-film electrodes.

Author

Muceli S, Poppendieck W, Negro F, Yoshida K, Hoffmann KP, Butler JE, Gandevia SC, and Farina D

Subjects
Adult, Electric Impedance, Electrodes, Electromyography, Humans, Male, Muscle Contraction physiology, Motor Neurons physiology, Muscles innervation, Muscles physiology
Abstract

Intramuscular electrodes developed over the past 80 years can record the concurrent activity of only a few motor units active during a muscle contraction. We designed, produced and tested a novel multi-channel intramuscular wire electrode that allows in vivo concurrent recordings of a substantially greater number of motor units than with conventional methods. The electrode has been extensively tested in deep and superficial human muscles. The performed tests indicate the applicability of the proposed technology in a variety of conditions. The electrode represents an important novel technology that opens new avenues in the study of the neural control of muscles in humans. We describe the design, fabrication and testing of a novel multi-channel thin-film electrode for detection of the output of motoneurones in vivo and in humans, through muscle signals. The structure includes a linear array of 16 detection sites that can sample intramuscular electromyographic activity from the entire muscle cross-section. The structure was tested in two superficial muscles (the abductor digiti minimi (ADM) and the tibialis anterior (TA)) and a deep muscle (the genioglossus (GG)) during contractions at various forces. Moreover, surface electromyogram (EMG) signals were concurrently detected from the TA muscle with a grid of 64 electrodes. Surface and intramuscular signals were decomposed into the constituent motor unit (MU) action potential trains. With the intramuscular electrode, up to 31 MUs were identified from the ADM muscle during an isometric contraction at 15% of the maximal force (MVC) and 50 MUs were identified for a 30% MVC contraction of TA. The new electrode detects different sources from a surface EMG system, as only one MU spike train was found to be common in the decomposition of the intramuscular and surface signals acquired from the TA. The system also allowed access to the GG muscle, which cannot be analysed with surface EMG, with successful identification of MU activity. With respect to classic detection systems, the presented thin-film structure enables recording from large populations of active MUs of deep and superficial muscles and thus can provide a faithful representation of the neural drive sent to a muscle., (© 2015 The Authors. The Journal of Physiology © 2015 The Physiological Society.)

Published
2015
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10. High resolution electroencephalography in freely moving mice.

Author

Choi JH, Koch KP, Poppendieck W, Lee M, and Shin HS

Subjects
Animals, Electroencephalography instrumentation, Female, Longitudinal Studies, Male, Mice, Mice, Inbred C57BL, Mice, Transgenic, Microelectrodes, Nanotechnology instrumentation, Brain physiology, Electroencephalography methods, Motor Activity physiology, Nanotechnology methods
Abstract

Electroencephalography (EEG) is a standard tool for monitoring brain states in humans. Understanding the molecular and cellular mechanisms underlying diverse EEG rhythms can be facilitated by using mouse models under molecular, pharmacological, or electrophysiological manipulations. The small size of the mouse brain, however, poses a severe limitation in the spatial information of EEG. To overcome this limitation, we devised a polyimide based microelectrode array (PBM array) with nanofabrication technologies. The microelectrode contains 32 electrodes, weighs 150 mg, and yields noise-insensitive signals when applied on the mouse skull. The high-density microelectrode allowed both global and focused mapping of high resolution EEG (HR-EEG) in the mouse brain. Mapping and dynamical analysis tools also have been developed to visualize the dynamical changes of spatially resolved mouse EEG. We demonstrated the validity and utility of mouse EEG in localization of the seizure onset in absence seizure model and phase dynamics of abnormal theta rhythm in transgenic mice. Dynamic tracking of the EEG map in genetically modified mice under freely moving conditions should allow study of the molecular and cellular mechanisms underlying the generation and dynamics of diverse EEG rhythms.

Published
2010
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