AJOB Neuroscience.

tDCS Research in a World With FDA Regulation

Wexler and Hamilton’s editorial on crowdsourced transcranial direct current stimulation (tDCS) research discusses the potential for such research to produce scientifically valuable information, the methodological obstacles to it actually doing so, and related ethical concerns. For example, a central concern is that because of the variability in the devices themselves and in what individuals aim to achieve through their tDCS use—including a range of enhancement and treatment goals—it may be difficult to draw any general conclusions from aggregated information about individual use. Wexler and Hamilton ultimately observe that some entity would need to take control over crowdsourced tDCS research to overcome the myriad methodological obstacles.

Building on their observations, this commentary begins to explore how U.S. Food and Drug Administration (FDA) regulation of tDCS products might affect both industry-sponsored and crowdsourced studies of commercially produced tDCS products intended for home use. Specifically, this commentary makes the case that the FDA exercising its authority to regulate in this area may have informational benefits by incentivizing greater research rigor. If realized, these benefits would be socially valuable because there is great hope for and hype about tDCS use, and consumers, currently, can access these products with relative ease. However, few clinical trials have studied the home use of tDCS such that its efficacy and long-term safety are uncertain.

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Volume 8, Issue 1
March 2017