Response to the electric brain

ABSTRACT

Transcranial direct current stimulation (tDCS) is swiftly entering the consumer marketplace. Do-it-yourself and direct-to-consumer uses are on the rise. Smith argues that the neuroscience community has an ethical imperative to watch over the consuming public at a time when the risks and benefits of tDCS technology are still uncertain. The real impetus for change will more likely come from agency regulation of consumer tDCS devices.

KEYWORDS:

• Transcranial direct current stimulation
• FDA
• regulation

1. Overview

The electric brain: do-it-yourself healthcare with transcranial direct current stimulation (tDCS) by Colton Smith is an intriguing snapshot of emerging challenges associated with consumer adoption of a simple, yet potentially powerful, neurological device. Smith’s discussion hinges on tDCS , a technology used to modulate neuron activity. tDCS was a highlighted topic at the 2016 OECD workshop, Neurotechnology and Society: Strengthening Responsible Innovation in Brain Science.

Although tDCS has been a known technology for a couple hundred years, Smith notes that tDCS appears to have been recently popularized among the citizen-scientist community, in addition to being used in its traditional neuroscience and clinical settings. The recent surge in tDCS popularity may be owed to the simplicity of design/use; interconnectedness of interested consumers; market opportunities for manufacturers; and regulatory gaps.

Smith notes that tDCS devices are simple to construct and use (although, perhaps not appropriately). Forum-based internet sites facilitate awareness and discussion regarding the individual application of tDCS devices. As such, it follows that manufacturers recognized the existence of an untapped market and began producing tDCS devices for consumer use and have purposely targeted this market accordingly. A recent analysis of tDCS regulation notes that there exists a regulatory gap that has allowed DIY and direct-to-consumer tDCS devices to pass outside food and drug administration (FDA) regulation (Wexler 2015).

Smith goes on to discuss several studies that suggest tDCS could prove to be beneficial in clinical settings, for treatment of stroke or depression, as well as in intelligence ‘enhancement.’ He then outlines six major concerns he has with tDCS use in a consumer setting. In this brief response, I will examine Smith’s six concerns and address his responses.

2. Response to concerns

It is important to note at the outset that Smith’s purpose in highlighting his concerns with consumer use – particularly DIY – of tDCS devices is to frame them on an ethical background. Smith’s primary focus appears to be on the ethical duties of the neuroscience community to respond to these consumer and technological uncertainties. In addition to conducting further research, he argues that the neuroscience community should lead the charge in educating the consuming public on the current understanding of tDCS including potential benefits and/or risks.

In responding to Smith’s concerns, it is also critical to keep in mind that I am not an expert in neuroscience. I consider myself an educated layperson, relying on general scientific background and rational thought processes. And, as a member of the legal community, my focus will inherently be shifted towards a regulatory analysis.

Smith’s six claims can be broken into three groups. Group 1 consists of a concern regarding public perception (Claim 1). Group 2 consists of concerns relating to consumer understanding of tDCS use and impacts (Claims 2–4). Group 3 consists of concerns pertaining to physical changes induced by tDCS (Claims 5–6).

2.1. Group 1 – public perception concerns

Smith’s first claim is that marketing tDCS devices as ‘non-invasive’ is a misnomer, ultimately creating a public perception concern. Specifically, Smith states that, although technically tDCS is not physically invasive in the accepted, clinical sense, tDCS nevertheless has impacts on physiology like that of invasive techniques. Furthermore, Smith argues that the term ‘non-invasive’ suggests a level of safety to consumers that may not actually be attributable to the technology.

As such, Smith suggests that a non-invasive/invasive distinction may be outdated, and so he proposes to call these tDCS devices ‘neuron-altering.’ His goal in implementing a new naming regime would be to signal to consumers, as well as physicians, that tDCS devices have more serious effects than a ‘non-invasive’ label would suggest.

My concerns with Smith’s proposition are twofold. First, I am skeptical as to the practical usefulness of attempting to describe tDCS devices as ‘neuron-altering.’ To my knowledge, there are three groups that produce and utilize tDCS technology: researchers, DIY users, and commercial manufacturers. Of these three groups, the only group such a nomenclature change would have traction in would be the researchers (as they are the ones Smith proposes would introduce these changes). DIY individuals are unlikely to be swayed by a change in name because they are already developing their own devices and have little use for specific nomenclature standards. In addition, manufacturers will not subscribe to name changes unless in response to significant public opinion or as required by law. And such legal requirements will necessarily be bounded to their respective jurisdictions. As will be discussed in other responses below, the wording used to describe a product has a substantial impact on how agencies, such as the FDA, ultimately regulate that product. Manufacturers likely will be loath to change voluntarily their description from ‘non-invasive’ to ‘neuron-altering.’

A second concern I have with the proposed nomenclature change is that I feel it will be unreachable for the average consumer. Regardless of where the consumer interacts with tDCS technology (clinical setting, DIY and direct-to-consumer), I am unconvinced that ‘neuron-altering’ or something of similar verbiage would assist consumers in understanding the potential risks of tDCS. Anecdotally, ‘neuron-altering,’ to me, suggests that I can expect permanent changes to my neuronal structures. Which neurons and how these neurons will change, however, is unclear.

It certainly would not hurt to have a guidance from the neuroscience community outlining how they believe the technology should be described in a consumer setting. Such outreach communications could come in the form of a National Academies of Sciences report or publication in a high-impact journal, such as Science or Nature. In addition, guidance material could be directly targeted at the DIY and direct-to-consumer community via consumer media outlets. However, I would not expect there to be significant changes in either manufacturer actions or consumer thinking. The real impetus for change will likely come through regulatory oversight.

2.2. Group 2 – use and impact concerns

The second group of concerns outlined by Smith can be categorized as use and impact concerns. The concerns involve the reality that stimulating an area of the brain will ultimately impact other parts of the brain because the brain is organized as a neural network. In addition, Smith notes that novice users (such as DIY users) may find themselves unintentionally stimulating non-target regions due to misplacement or being in proximity, as well the potential for stimulating both excitatory and inhibitory neurons at the same time.

These concerns highlight the fact that neuroscientists have a limited understanding at this time of the effects of widespread and chronic use of tDCS, especially in a DIY setting. Smith argues that consumer unawareness as to the proper methods and uses of tDCS devices could lead to harm, and that neuroscientists should play a role in promoting awareness.

I agree with Smith in that education plays a serious role in safety. And certainly, developing an educated consumer base would be an ideal way to minimize consumer tDCS-related injuries. But, given the nature of the groups who use tDCS, education may end up with mixed results. The most effective tool for influencing consumer knowledge and use of a device would be through FDA regulation. And at present, the FDA does not regulate tDCS devices. It is yet to be seen if the FDA will claim authority to fill this gap or if the agency believes it does not have the authority whatsoever.

Much like in response to Group 1 concerns, the neuroscience community could release guidances as to the proper use and impact of tDCS devices. That being said, I believe that FDA regulation will be the most impactful tool, because of its broad capacity to develop and enforce consumer product requirements.

2.3. Group 3 – physiological changes

The last group of concerns that Smith discusses are concerns regarding potential physiologically induced changes by tDCS devices. In particular, Smith is concerned with the potential for altering the development of an adolescent brain, as well as the potential for addiction.

I share Smith’s concerns and agree that the road of precaution should be followed until further research can bring to light the validity of these concerns. That being said, I find it entirely plausible that future research will be inconclusive or show conflicting results. If this is indeed the case, use of tDCS may simply be a choice, much like the choice to smoke cigarettes or drink coffee is today (i.e. buyer beware). Even more so, denoting tDCS as illegal for individual use (say, outside a clinical setting) may not have a significant deterrence effect given the ease with which one can create a DIY version. Indeed, federal and state enforcement of tDCS regulations on DIY users appears a nigh impossible task. Barring line-of-sight observation of devices or affirmative statements by the DIY users, DIY tDCS devices are virtually invisible to enforcement mechanisms due to their simplicity in construction and use.

In short, I find Smith’s concerns regarding the effect of tDCS on developing brains and addiction to be worthwhile research endeavors.

3. Steps forward

Although I understand Smith’s point about how the neuroscience community may perceive an ethical duty to consumers and individuals who use tDCS devices, I think there is a particular pathway that should be used to fulfill that duty. The neuroscience community can best serve the interests of the consuming public by conducting research on the safety and efficacy of tDCS technology. Specifically, short-term and long-term studies to identify acute and chronic side effects of tDCS usage would be appropriate. The community could then use that information to develop standards and subsequently inform regulatory agencies such as the FDA of their findings. By maintaining a dialogue with regulatory agencies, the neuroscience community can funnel their expertise towards an entity that has power to enact serious, sweeping changes for the consumer population. Future research will inform the regulatory policy, ultimately having an impact on consumers. But until that point, I see little in the way of practical results if the neuroscience community directly targets consumers, particularly DIY consumers, as to the risks and benefits of tDCS devices.

As with any new technology, there is a lapse between introduction to the market and full understanding of the associated risks. These individuals who use tDCS in a DIY setting are mostly unreachable by any regulatory standards and attempts to reach them for altruistic purposes will not likely have serious impact. Likewise, direct-to-consumer tDCS purchasers will likely rely on the traditional methods of product information gathering, such as product packaging and claims. The better route will be to target the FDA. After all, the FDA is an evidence-based policy-making body better suited to balancing scientific evidence and consumer protection.

Disclosure statement

No potential conflict of interest was reported by the author.

Notes on contributor

Nathaniel D. May is a J.D. Candidate ’17 at the Sandra Day O’Connor College of Law at Arizona State University. He received his M.A. in Bioethics from Wake Forest University in 2014 and his B.S. in Molecular and Cellular Biology from the University of Arizona in 2013.