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

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. We therefore convened a group of research and clinician experts on tDCS to review the research and clinical use of tDCS. In this report, we review the regulatory status of tDCS, and we summarize 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 United States. 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.

Electrophoresis of cell membrane heparan sulfate regulates galvanotaxis in glial cells

“…Understanding how endogenous EFs could guide cell migration and how an applied EF could potentially be leveraged to modulate this process provide a rationale for new therapeutics. For example, transcranial direct current stimulation (tDCS) has shown clinical benefits for central nervous system diseases (Fregni et al, 2015) and was able to promote cathodal accumulation of endogenous neural stem cells (Rueger et al, 2012). As more is learned about the role of bioelectricity on cell function it is likely that new opportunities for interventions will emerge.…”

Anodal-tDCS over the human right occipital cortex enhances the perception and memory of both faces and objects

“…A few minutes of stimulation can induce after-effects, which reflect calcium (Ca + )-dependent plastic changes mediated by the N-methyl-D-aspartate receptor (NMDA-R), thus resembling long-term-potentiation (LTP)-and long-term-depression (LTD)-like plasticity (Liebetanz, Nitsche, Tergau, & Paulus, 2002;Nitsche, Fricke, et al, 2003;Nitsche et al, 2004). Depolarisation is typically achieved via "anodal" stimulation, whereas 4 hyperpolarisation typically follows "cathodal" stimulation (Fregni et al, 2015). In the context of tDCS, "polarity" refers to the polarity of the electrode positioned over the target region.…”

Effects of regiolects on the perception of developmental foreign accent syndrome

“…tDCS was delivered through a TCT Research tDCS 1ch stimulator (2012 TCT Research Limited, Hong Kong) and 2 5 by 5 cm rubber-sponge electrodes. Parameters were set at: 2mA intensity, 10 minutes duration, with a 15 second ramping up/down period at the start and end of the stimulation (cathodal stimulation) (Fregni et al 2014). The sham condition uses the same parameters but the stimulator automatically turns off current after 30 seconds.…”