Abstract
This chapter reviews evidence on the safety of transcranial Direct Current Stimulation (tDCS) with the specific and limited definition of safety as the absence of evidence for a Serious Adverse Effect, the criteria of which are explained. The chapter adopts an evidence-based approach, using an aggregation of research experience from both animal studies and trials in human subjects. Safety data from animal tests for tissue damage are reviewed along with insight into how to relate animal dosage to human dosage. This includes utilizing computational models. The chapter presents relevant dose-response curves and dose metrics (including current, duration, current density, charge, charge density) for meaningful safety standards. Special consideration is given to populations that could be more vulnerable including children and the elderly, subjects with mood disorders, stroke, epilepsy, implants, and those employing at-home tDCS approach. The data summarized in this chapter support the conclusion reached by prior review that there is no evidence suggesting that conventional tDCS protocols, as commonly implemented in either healthy subjects or patient populations in clinical trials, increase risk of serious adverse events. Evidently, as with any novel treatment options, continuing research and vigilance are warranted. Based on the specific definition of safety set forth, the chapter on safety does not address tolerability or general issues related to adverse event monitoring. This chapter avoids specific recommendations or endorsements on protocols, but rather focuses on presenting the evidence for safety.
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Grossman, P., Woods, A.J., Knotkova, H., Bikson, M. (2019). Safety of Transcranial Direct Current Stimulation. In: Knotkova, H., Nitsche, M., Bikson, M., Woods, A. (eds) Practical Guide to Transcranial Direct Current Stimulation. Springer, Cham. https://doi.org/10.1007/978-3-319-95948-1_6
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