*This post was originally published on The Neuroethics Blog.
By Anna Wexler
Anna Wexler is a PhD candidate in the HASTS (History, Anthropology, Science, Technology and Society) at MIT and a 2015-2016 visiting scholar at the Center for Neuroscience and Society at the University of Pennsylvania. Her dissertation focuses on the ethical, legal and social implications of emerging neuroscience technology, with a particular focus on the home use of noninvasive brain stimulation.
Just when it seemed like the consumer neurotechnology market couldn’t get any stranger—after all, who would’ve expected that a sleek white triangle could be placed on the forehead for “calm” or “energy” vibes—two new products recently hit the market that further complicate the challenges of regulating this emerging market. Halo Sport is a brain stimulator marketed for athletic enhancement that utilizes technology similar to transcranial direct current stimulation (tDCS), while Nervana, which began taking pre-orders in March, is the first noninvasive vagus nerve stimulation (VNS) device to be sold directly to the public in the United States.
Halo Neuroscience, the manufacturer of Halo Sport, advertises that its product “accelerates gains in strength, explosiveness, and dexterity.” In many ways, Halo Sport overcomes obstacles that have plagued other direct-to-consumer brain stimulation products. Because Halo Sport only claims to stimulate the motor cortex—which, conveniently for the company, lies beneath the area of the head where a pair of headphones might sit—the product does not utilize stray wires or a futuristic headset, but instead takes the recognizable shape of headphones. The beneficial effect of a familiar design should not be underestimated: many potentially useful technology tools have failed in no small part due to their unusual “look.”
One of the other barriers to wider uptake of consumer brain stimulation has been that the gains are, for the most part, relatively small. (In fact, it is debated whether tDCS provides any enhancement effect at all.) Even if a product provides a 5% or 10% improvement on cognitive or motor tasks, such a gain might be hardly noticeable to the average individual. But in the realm of professional athletes, small percentage increases are everything: the dividing line between a world champion sprinter and one who does not rank can be measured on the order of milliseconds. Thus, Halo’s decision to cater exclusively to athletes—a population for whom fractional gains in performance separate winners from losers—is a brilliant marketing move.
Though it is less clear who the intended market of “Nervana” is, the company has clearly struck a nerve (literally): their IndieGogo campaign netted a whopping $581,547 in pre-sales. The product, which is billed as the “The World’s First Consumer Product to Stimulate the Body’s Pleasure Center in Synchronicity to Music” also takes a familiar shape: earbuds are connected to a portable stimulation device that is vaguely reminiscent of a first-generation iPod. According to the company, in “Music Mode,” the device “generates a targeted vagus nerve stimulation output” via the earbuds that synchronizes with whatever music is being played. Since the vagus nerve is involved with the release of neurotransmitters, the company claims that its product promotes the release of dopamine and effectively gets you “high.”
Whether or not these products work as claimed is one issue—Halo, to its credit, has posted a considerable amount of data, though it has yet to be peer-reviewed—because by virtue of being on the market they present difficult problems for regulators. As I have written elsewhere, the question of whether consumer noninvasive brain stimulation devices should be regulated by the Food and Drug Administration (FDA) often comes down to the question of whether or not brain stimulation devices that make only “wellness” or “enhancement” claims can be classified as “medical devices.” So far, however, the discussion of the regulation of direct-to-consumer brain stimulation products has focused on cognitive and mood enhancement. But Halo Sport throws a wrench into the regulatory conversation: would brain stimulation products that claim to athletically enhance be treated differently than those that claim to cognitively enhance? In other words: is there a meaningful regulatory difference between different types of enhancement (mood, cognition, athletics)?
In addition, while Halo Sport is based on tDCS—a technique that is not yet FDA-approved for any indication and therefore has no direct regulatory precedent—the situation with Nervana is slightly more complex. An implantable VNS device—that is, one that requires surgery and sits inside the body—has been FDA approved to treat epilepsy, and has shown efficacy in off-label use to treat depression. Nervana, however, claims to stimulate the vagus nerve from outside the body, through the skin. Though there are preliminary studies on using this kind of transcutaneous VNS (or, tVNS) to treat neuropsychiatric disorders, as of yet, the FDA has not yet approved a tVNS device for use in the United States. Thus, Nervana represents a noninvasive version of an invasive device that is FDA-regulated for treating medical conditions.
In addition to questions regarding state and federal regulatory pathways, it remains to be seen how direct-to-consumer electrical stimulation products will be regulated by professional organizations. Neuroethicists have long compared cognitive enhancement to athletic enhancement, but Halo Sport represents the first time that “electrical doping” for sports has been neatly packaged in a direct-to-consumer product. If the product (and copycat ones) gain a foothold, professional sports organizations will have to decide how to regulate their competitive use. Should agencies ban electrical doping, or perhaps restrict their use to training (and not competition)? Whatever position is taken, the rules will be challenging to enforce, as electrical stimulation may not leave detectable traces in blood or urine.
In the months to come, additional variations of direct-to-consumer electrical stimulation devices are likely to appear, and these products will raise questions that fall squarely at the intersection of law, ethics, and (neuro)science. While to date, the “neurolaw” field has centered on questions of neuroscience in the courtroom, the rise of direct-to-consumer neurotechnology suggests that scholars should pay more attention to how neuroscience enters other realms of law—particularly the regulatory arena.