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152. Regulatory considerations for the clinical and research use of transcranial direct current stimulation (tDCS): Review and recommendations from an expert panel.

Author

Fregni, F., Nitsche, M. A., Loo, C. K., Brunoni, A. R., Marangolo, P., Leite, J., Carvalho, S., Bolognini, N., Caumo, W., Paik, N. J., Simis, M., Ueda, K., Ekhtiari, H., Luu, P., Tucker, D. M., Tyler, W. J., Brunelin, J., Datta, A., Juan, C. H., and Venkatasubramanian, G.

Subjects
*TRANSCRANIAL direct current stimulation, *CLINICAL trials, *MEDICAL research, *NEUROSCIENCES
Abstract

The field of transcranial electrical stimulation (tES) has experienced significant growth in the past 15 years. One of the tES techniques leading this increased interest is transcranial direct current stimulation (tDCS). Significant research efforts have been devoted to determining the clinical potential of tDCS in humans. Despite the promising results obtained with tDCS in basic and clinical neuroscience, further progress has been impeded by a lack of clarity on international regulatory pathways. Therefore, a group of research and clinician experts on tDCS were convened to review the research and clinical use of tDCS. This report reviews the regulatory status of tDCS and summarizes the results according to research, off-label, and compassionate use of tDCS in the following countries: Australia, Brazil, France, Germany, India, Iran, Italy, Portugal, South Korea, Taiwan, and the US. Research use, off label treatment, and compassionate use of tDCS are employed in most of the countries reviewed in this study. It is critical that a global or local effort is organized to pursue definite evidence to either approve and regulate or restrict the use of tDCS in clinical practice on the basis of adequate randomized controlled treatment trials. [ABSTRACT FROM AUTHOR]

Published
2015
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159. Authors' reply

Author

Fregni, F., primary, Boggio, P., additional, Nitsche, M. A., additional, and Pascual-Leone, A., additional

Published
2005
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163. DEGRO 2004

Author

Wendt, Thomas G., primary, Gademann, G., additional, Pambor, C., additional, Grießbach, I., additional, von Specht, H., additional, Martin, T., additional, Baltas, D., additional, Kurek, R., additional, Röddiger, S., additional, Tunn, U. W., additional, Zamboglou, N., additional, Eich, H. T., additional, Staar, S., additional, Gossmann, A., additional, Hansemann, K., additional, Semrau, R., additional, Skripnitchenko, R., additional, Diehl, V., additional, Müller, R.-P., additional, Sehlen, S., additional, Willich, N., additional, Rühl, U., additional, Lukas, P., additional, Dühmke, E., additional, Engel, K., additional, Tabbert, E., additional, Bolck, M., additional, Knaack, S., additional, Annweiler, H., additional, Krempien, R., additional, Hoppe, H., additional, Harms, W., additional, Daeuber, S., additional, Schorr, O., additional, Treiber, M., additional, Debus, J., additional, Alber, M., additional, Paulsen, F., additional, Birkner, M., additional, Bakai, A., additional, Belka, C., additional, Budach, W., additional, Grosser, K.-H., additional, Kramer, R., additional, Kober, B., additional, Reinert, M., additional, Schneider, P., additional, Hertel, A., additional, Feldmann, H., additional, Csere, P., additional, Hoinkis, C., additional, Rothe, G., additional, Zahn, P., additional, Alheit, H., additional, Cavanaugh, S. X., additional, Kupelian, P., additional, Reddy, C., additional, Pollock, B., additional, Fuss, M., additional, Roeddiger, S., additional, Dannenberg, T., additional, Rogge, B., additional, Drechsler, D., additional, Herrmann, T., additional, Alberti, W., additional, Schwarz, R., additional, Graefen, M., additional, Krüll, A., additional, Rudat, V., additional, Huland, H., additional, Fehr, C., additional, Baum, C., additional, Glocker, S., additional, Nüsslin, F., additional, Heil, T., additional, Lemnitzer, H., additional, Knips, M., additional, Baumgart, O., additional, Thiem, W., additional, Kloetzer, K.-H., additional, Hoffmann, L., additional, Neu, B., additional, Hültenschmidt, B., additional, Sautter-Bihl, M.-L., additional, Micke, O., additional, Seegenschmiedt, M. H., additional, Köppen, D., additional, Klautke, G., additional, Fietkau, R., additional, Schultze, J., additional, Schlichting, G., additional, Koltze, H., additional, Kimmig, B., additional, Glatzel, M., additional, Fröhlich, D., additional, Bäsecke, S., additional, Krauß, A., additional, Strauß, D., additional, Buth, K.-J., additional, Böhme, R., additional, Oehler, W., additional, Bottke, D., additional, Keilholz, U., additional, Heufelder, K., additional, Wiegel, T., additional, Hinkelbein, W., additional, Rödel, C., additional, Papadopoulos, T., additional, Munnes, M., additional, Wirtz, R., additional, Sauer, R., additional, Rödel, F., additional, Lubgan, D., additional, Distel, L., additional, Grabenbauer, G. G., additional, Sak, A., additional, Stüben, G., additional, Pöttgen, C., additional, Grehl, S., additional, Stuschke, M., additional, Müller, K., additional, Pfaffendorf, C., additional, Mayerhofer, A., additional, Köhn, F. 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L., additional, Seaborn, R., additional, Rai, P., additional, Rha, S.-W., additional, Sakas, G., additional, Wesarg, S., additional, Zogal, P., additional, Schwald, B., additional, Seibert, H., additional, Berndt-Skorka, R., additional, Seifert, G., additional, Schoenekaes, K., additional, Bilecen, C., additional, Ito, W., additional, Matschuck, G., additional, and Isik, D., additional

Published
2004
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176. Linear Waves and Nonlinear Wave Interactions in a Bounded Three-Layer Fluid System.

Author

Weidman, P. D., Nitsche, M., and Howard, L.

Subjects
*SOLITONS, *LINEAR systems, *FLUID dynamics, *COMPUTER simulation, *NONLINEAR systems, *EXISTENCE theorems, *APPLIED mathematics
Abstract

We investigate possible linear waves and nonlinear wave interactions in a bounded three-layer fluid system using both analysis and numerical simulations. For sharp interfaces, we obtain analytic solutions for the admissible linear mode-one parent/signature waves that exist in the system. For diffuse interfaces, we compute the overtaking interaction of nonlinear mode-two solitary waves. Mathematically, owing to a small loss of energy to dispersive tails during the interaction, the waves are not solitons. However, this energy loss is extremely minute, and because the dispersively coupled waves in the system exhibit the three types of Lax KdV interactions, we conclude that for all intents and purposes the solitary waves exhibit soliton behavior. [ABSTRACT FROM AUTHOR]

Published
2012
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177. High-dynamic-range magnetometry with a single nuclear spin in diamond.

Author

Waldherr, G., Beck, J., Neumann, P., Said, R. S., Nitsche, M., Markham, M. L., Twitchen, D. J., Twamley, J., Jelezko, F., and Wrachtrup, J.

Subjects
DETECTORS, NITROGEN, MAGNETIC fields, ELECTRIC fields, DIAMONDS
Abstract

Sensors based on the nitrogen-vacancy defect in diamond are being developed to measure weak magnetic and electric fields at the nanoscale. However, such sensors rely on measurements of a shift in the Lamor frequency of the defect, so an accumulation of quantum phase causes the measurement signal to exhibit a periodic modulation. This means that the measurement time is either restricted to half of one oscillation period, which limits accuracy, or that the magnetic field range must be known in advance. Moreover, the precision increases only slowly (as T?0.5) with measurement time T (ref. 3). Here, we implement a quantum phase estimation algorithm on a single nuclear spin in diamond to combine both high sensitivity and high dynamic range. By achieving a scaling of the precision with time to T?0.85, we improve the sensitivity by a factor of 7.4 for an accessible field range of 16 mT, or, alternatively, we improve the dynamic range by a factor of 130 for a sensitivity of 2.5 µT Hz?1/2. Quantum phase estimation algorithms have also recently been implemented using a single electron spin in a nitrogen-vacancy centre. These methods are applicable to a variety of field detection schemes, and do not require quantum entanglement. [ABSTRACT FROM AUTHOR]

Published
2012
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179. Evolution of solitary waves in a two-pycnocline system.

Author

Nitsche, M., Weidman, P. D., Grimshaw, R., Ghrist, M., and Fornberg, B.

Subjects
SOLITONS, INTERNAL waves, RESONANT vibration, TRANSITION flow, DIFFUSION in hydrology, COMPUTER simulation
Abstract

Over two decades ago, some numerical studies and laboratory experiments identified the phenomenon of leapfrogging internal solitary waves located on separated pycnoclines. We revisit this problem to explore the behaviour of the near resonance phenomenon. We have developed a numerical code to follow the long-time inviscid evolution of isolated mode-two disturbances on two separated pycnoclines in a three-layer stratified fluid bounded by rigid horizontal top and bottom walls. We study the dependence of the solution on input system parameters, namely the three fluid densities and the two interface thicknesses, for fixed initial conditions describing isolated mode-two disturbances on each pycnocline. For most parameter values, the initial disturbances separate immediately and evolve into solitary waves, each with a distinct speed. However, in a narrow region of parameter space, the waves pair up and oscillate for some time in leapfrog fashion with a nearly equal average speed. The motion is only quasi-periodic, as each wave loses energy into its respective dispersive tail, which causes the spatial oscillation magnitude and period to increase until the waves eventually separate. We record the separation time, oscillation period and magnitude, and the final amplitudes and celerity of the separated waves as a function of the input parameters, and give evidence that no perfect periodic solutions occur. A simple asymptotic model is developed to aid in interpretation of the numerical results. [ABSTRACT FROM AUTHOR]

Published
2010
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184. Developing a truly customer-centric CRM system: Part One — Strategic and architectural implementation

Author

Nitsche, M

Abstract

For several decades, banks in Germany were in hibernation. They had little interest in private customers and small corporates. This has changed massively over the past few years, and now there is barely a day when there is no news of some planned or failed merger, closure of branches or other new initiative. People and markets are changing just as the competition is. This — alongside rapid technological progress — is resulting in permanent modifications and the active embracing of the changes involved. Deutsche Bank 24 is one of the banks which has embarked on this course and actively moulded it over the past few years. This two-part paper firstly examines CRM in the context of Deutsche Bank 24, and in the second part looks closely at analytical approaches to various business opportunities and their implementation.

Published
2002
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193. P040 Restoration of abnormal muscular cramping in musicians’ dystonia through bihemispheric transcranial direct current stimulation and bimanual motor retraining.

Author

Furuya, S., Nitsche, M., Paulus, W., and Altenmüller, E.

Subjects
*MUSCLE disease treatment, *TRANSCRANIAL direct current stimulation, *TREATMENT of dystonia, *FOCAL dystonia, *NEUROPHYSIOLOGY
Abstract

Question Task-specific focal dystonia (TSFD) is typically characterized by involuntary and abnormal muscular cramping, which compromises fine motor control. Previous neurophysiological studies have identified loss of inhibitory control at the motor cortex as a possible pathophysiology of the dystonic cramping. A recent study demonstrated that bi-hemispheric transcranial direct current stimulation (tDCS) over the motor cortices during performing bimanual mirrored finger movements ameliorated impairment of dexterous finger movements in pianists with TSFD. However, little has been uncovered about its underlying neurophysiological mechanism. Here we tested a hypothesis that the bi-hemispheric tDCS with motor retraining normalizes abnormal co-contraction between antagonistic pairs of extrinsic finger muscles in pianists with TSFD. Methods Eight pianists suffering from TSFD at the right hand and eight healthy pianists performed the bimanual mirrored finger movements for twenty-four minutes with two conditions; either with 2 mA tDCS over the motor cortices (cathodal over the left and anodal over the right) for twenty-four minutes (real condition) or thirty seconds (sham condition). Results The results demonstrated changes in pattern of muscular co-contraction only following the real stimulation condition, in which tonic activity turned into more phasic pattern. In addition, the amount of muscular co-contraction was significantly decreased after the real stimulation in the patients, which was the case neither at the sham condition of the patients nor at both conditions of the healthy controls. Conclusions The results provide physiological evidences of restoration of both abnormal pattern and amount of muscular co-activation of musicians’ dystonia through the bi-hemispheric tDCS with bimanual motor retraining. [ABSTRACT FROM AUTHOR]

Published
2017
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195. Transcranial direct current stimulation.

Author

Fregni, F., Boggio, P. S., Nitsche, M., and Pascual-Leone, A.

Subjects
LETTERS to the editor, MENTAL depression, THERAPEUTICS, ELECTROCONVULSIVE therapy, ELECTROTHERAPEUTICS, MAGNETICS
Abstract

A letter to the editor is presented in response to the article "Depression intervention in resource-poor regions" by K.A.L.A. Kuruppuarachchi and L.T. Wijeratne in the 2004 issue.

Published
2005
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196. Enhanced fear acquisition in individuals with evening chronotype. A virtual reality fear conditioning/extinction study.

Author

Lucifora, Chiara, Grasso, Giorgio M., Nitsche, Michael A., D'Italia, Giovanni, Sortino, Mauro, Salehinejad, Mohammad A., Falzone, Alessandra, Avenanti, Alessio, Vicario, Carmelo M., Lucifora, C, Grasso, G, Nitsche, M A, D'Italia, G, Sortino, M, Salehinejad, M A, Falzone, A, Avenanti, A, and Vicario, C M

Subjects
*MORNINGNESS-Eveningness Questionnaire, *VIRTUAL reality, *GALVANIC skin response, *RECOLLECTION (Psychology), *POST-traumatic stress disorder, *CLASSICAL conditioning, *MEMORY, *FEAR, *REINFORCEMENT (Psychology), *CHRONOTYPE, *CONDITIONED response
Abstract

Circadian rhythms have received increasing attention within the context of mental disorders. Evening chronotype has been associated with enhanced risk to develop anxiety and post-traumatic stress disorder (PTSD). The classical fear conditioning paradigm is a powerful tool to reveal key mechanisms of anxiety and PTSD. We used this paradigm to study the neurocognitive basis of the association between chronotype and fear responses in healthy humans. 20 participants with evening chronotype and 20 controls (i.e., intermediate chronotype) completed a 2-day Pavlovian fear learning and extinction virtual reality task. Participants received fear conditioning, and extinction learning on day 1. Extinction memory recall was tested on day 2. To address interactions between chronotype and time of day of the fear conditioning, and extinction performance, half of the participants were tested in the morning, and the other half in the evening. Skin conductance response (SCR) and subjective fear ratings were measured as primary outcomes. Chronotype was established via the morningness-eveningness questionnaire (MEQ). We found an overall higher SCR for fear acquisition in participants with the evening chronotype profile, compared to controls. Moreover, the higher the MEQ scores -indicative of less eveningness - the lower the SCR was. No effects of chronotype were found for extinction and extinction recall. The higher vulnerability of the evening chronotype for anxiety and related disorders may thus be explained by enhanced fear acquisition of this group. [ABSTRACT FROM AUTHOR]

Published
2022
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197. Transcranial direct current stimulation of the premotor cortex: Effects on hand dexterity.

Author

Pavlova, E., Kuo, M. F., Nitsche, M. A., and Borg, J.

Subjects
*TRANSCRANIAL direct current stimulation, *PREMOTOR cortex, *MOTOR learning, *MOTOR ability, *TASK performance, *HAND physiology
Abstract

Premotor cortex activity is associated with complex motor performance and motor learning and offers a potential target to improve dexterity by transcranial direct current stimulation (tDCS). We explored the effects of tDCS of premotor cortex on performance of a Strength-Dexterity test in healthy subjects. METHODS: During the test a slender spring held between thumb and index finger should be compressed as much as possible without buckling. Finger forces assessed in the test provided a measure of dexterity. First, task performance was tested in 12 persons during anodal tDCS to the primary motor cortex (M1) contralateral to the performing hand, and sham stimulation. Another 12 persons participated in five sessions of anodal and cathodal tDCS over the left and the right premotor cortex and sham stimulation. RESULTS: tDCS over M1 as well as over the left, but not the right premotor cortex resulted in significant improvement of performance. Performance alterations correlated positively between left anodal and right cathodal tDCS and negatively between anodal tDCS of the two sides. Effective polarity for premotor stimulation to improve task performance differed between participants. Individuals who improved with anodal stimulation used lower finger force and experienced the test as more difficult compared to those who improved with cathodal stimulation. CONCLUSIONS: This study demonstrates that tDCS over the left premotor cortex can improve performance of a dexterity demanding task. The effective polarity of stimulation depends on the task performance strategies. The study moreover shows a functional relevance of interactions between the left and right premotor cortex. [ABSTRACT FROM AUTHOR]

Published
2014
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198. Higher variability of phosphene thresholds in migraineurs than in controls: a consecutive transcranial magnetic stimulation study.

Author

Antal, A., Arlt, S., Nitsche, M. A., Chadaide, Z., and Paulus, W.

Subjects
*MIGRAINE, *TRANSCRANIAL magnetic stimulation, *CEREBRAL cortex, *PHOSPHENES, *MIGRAINE aura, *HEADACHE
Abstract

The aim of this study was to characterize the temporal course of phosphene thresholds (PT) using transcranial magnetic stimulation (TMS) in control subjects and in subjects with migraine and to observe whether changes in PT over time can predict a subsequent migraine attack. PTs were measured in 16 migraineurs [nine with aura (MA) and seven without aura (MoA)] and nine controls five times over an approximately 10-week period. Mean PTs were not significantly different between migraineurs and controls; however, there was a trend in MA showing lower thresholds. The minimum threshold values were also smaller in MA subjects than in MoA or control subjects. Generally, PTs had higher variance in migraineurs than in controls, revealing a significant increase in standard deviation of PTs in MA subjects. There was no significant difference of thresholds from the first to the last stimulation in controls and in MoA subjects, but the 3rd, 4th and 5th measurements of MA subjects were significantly lower than their first measurements. Four migraineurs experienced headache within 1 day after one of the measurements. They had either very low or very high PTs compared with the PT values which were not followed by a migraine attack. Our results imply that migraineurs show a higher variability among PT measurements over time than controls, revealing unstable excitability levels in these patients. Additionally, both particularly high and low PTs might predict a subsequent headache in some individuals. [ABSTRACT FROM AUTHOR]

Published
2006
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199. Altered motion perception in migraineurs: evidence for interictal cortical hyperexcitability.

Author

Antal, A., Temme, J., Nitsche, M. A., Varga, E. T., Lang, N., and Paulus, W.

Subjects
*MEDICAL research, *VISION disorders, *MIGRAINE, *HEADACHE, *MOTION perception (Vision)
Abstract

Much research on visual functions in migraine has pinpointed the existence of abnormal visual processing between attacks. However, it is not clear if this is due to cortical hyper- or hypoexcitability. We aimed to clarify this issue by comparing motion perception thresholds of subjects with migraine with (MA) or without aura (MoA) and control subjects. Two types of dot kinetograms were used: in the first experiment coherently moving dots were presented in an incoherent environment, while in the second only coherent motion was seen. Subjects with migraine displayed significantly impaired motion perception compared with controls when they had to detect the direction of the coherently moving dots in an incoherent environment, while they were slightly better in a direction discrimination task, where only coherent motion was presented. This pattern of results is comparable to those achieved by an external excitability enhancement of V5 induced in healthy human subjects in a former study of our group. According to this, a cortical excitability enhancement can result in an impaired focusing on a given signal against a noisy background, but improves perception of non-ambiguous stimuli. Thus we conclude that migraineurs display enhanced visual cortical excitability between attacks in V5. [ABSTRACT FROM AUTHOR]

Published
2005
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200. Isometric agonist and antagonist muscle activation interacts differently with 140-Hz transcranial alternating current stimulation aftereffects at different intensities.

Author

Shorafa, Y., Halawa, I., Hewitt, M., Nitsche, M. A., Antal, A., and Paulus, W.

Abstract

During transcranial electric stimulation, increasing intracellular Ca2+ levels beyond those needed for inducing long term potentiation (LTP) may collapse aftereffects. State-dependent plastic aftereffects are reduced when applied during muscle activation as compared with rest. Cortical surround inhibition by antagonistic muscle activation inhibits the center-innervated agonist. The objective of this study is to determine the interaction of state dependency of transcranial alternating current stimulation (tACS) aftereffects at rest and under activation of agonist and antagonist muscles during stimulation with different intensities. In 13 healthy participants, we measured motor-evoked potential (MEP) amplitudes before and after applying tACS at 140 Hz over the motor cortex in nine single-blinded sessions using sham, 1 mA, and 2 mA stimulation intensities during rest and activation of agonist and antagonist muscles. During rest, only 1 mA tACS produced a significant MEP increase, whereas the 2 mA stimulation produced no significant MEP size shift. During agonist activation 1 mA did not induce MEP changes; after 2 mA, first a decrease and later an increase of MEPs were observed. Antagonist activation under sham tACS led to an inhibition, which was restored to baseline by 1 and 2 mA tACS. Increasing stimulation intensity beyond 1 mA does not increase excitability, compatible with too strong intracellular Ca2+ increase. Antagonist innervation leads to MEP inhibition, supporting the concept of surround inhibition, which can be overcome by tACS at both intensities. During agonist innervation, a tACS dose-dependent relationship exists. Our results integrate concepts of “leaky membranes” under activation, surround inhibition, intracellular Ca2+ increase, and their role in the aftereffects of tACS. NEW & NOTEWORTHY Stimulation intensity and activation of center versus surround muscles affect cortical excitability alterations generated by 140-Hz tACS. At rest, excitatory aftereffects were induced by tACS with 1 mA, but not 2 mA stimulation intensity. With agonistic muscle activation, excitability first decreases, and then increases with 2 mA. For antagonist activation, the MEP amplitude reduction observed in the sham condition is counteracted upon by 1 and 2 mA tACS. This reflects the relation of LTP-like aftereffects to Ca2+ concentration alterations. [ABSTRACT FROM AUTHOR]

Published
2021
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