Cortical Turf Wars
When the consumer neurotech startup Thync announced that it had been exempted from FDA approval of its new brain stimulation device, not everyone was happy. Some established vendors of medical-grade cortical stimulation devices groused openly that the FDA might have been too lenient in allowing new devices like Thync’s on the market without more testing and oversight. With several new vendors of consumer tDCS devices like Halo Neuroscience and foc.us soon to be or already on the market, this controversy is likely to heat up.
Adding fuel to the fire is a recent publication in the journal Experimental Brain Research that claims that the foc.us tDCS headset impairs working memory. “foc.us is just one example of a device that can easily be purchased and, without any control or expert knowledge, used by anyone. Claims made by companies manufacturing such devices need to be validated,” the Dutch authors conclude.
Without getting into the merits of the single-blind study, a couple things trouble us. First, 20 of the 24 subjects were female. Aside from gender issues, we wonder about differing amounts of hair and how that affects lead integrity. Second, the authors contend that they used the only electrode positions allowed by the vendor, but when we spoke to foc.us at the Neurogaming conference earlier this year, they demonstrated a highly configurable device. Company executives expressed agnosticism with respect to stimulation paradigms, advising customers to do their own research to find a stimulation regimen that produces optimal results. Most troubling is that the authors accept the vast amount of research supporting cognitive enhancement with anodal tDCS stimulation yet provide no thoughts on why this particular device deviates from the trend.
Clearly the FDA should monitor the safety of these new devices and the claims made by their manufacturers. But it is not the role of the FDA to protect market share of existing device vendors. There is indeed an enormous amount of new research that must be conducted before we can know with any degree of certainty whether and how noninvasive brain stimulation devices improve performance or address neurological disorders. But keeping new consumer-oriented devices off the market is not the way to accomplish that goal. If anything, exposing the capabilities of brain sensing and stimulating headsets to a wider audience of potential users may help drive demand for higher-quality medical grade systems. And many of the students and “citizen” scientists whose appetites for brain research we whet with low-cost consumer-grade devices today may become the next generation of neuroscience researchers and entrepreneurs who advance both consumer and medical neurotechnology in the future.
James Cavuoto
Editor and Publisher