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A Stimulus Plan?

Interest is growing in brain stimulation devices — and regulating them may prove tricky.

It may sound unusual, but it’s true: In recent years a growing number of people have been hooking their heads up to electrodes, in an attempt to stimulate their brains using a direct electrical current. Some of them do this via homemade devices; others may be using a new direct-to-consumer kit that just hit the market.

But why, exactly, are people doing such a thing at all? And to what extent should this practice — seen only in research labs until a few years ago — be regulated?

The first question is easier to answer than the second, according to Anna Wexler, a PhD student in MIT’s Program in Science, Technology, and Society, who had two new papers on the subject appear in academic journals this fall. Following lab research that started appearing 15 years ago, some people believe they can give themselves a kind of neurological tuneup through electrical stimulation, producing better-functioning brains.

“The common thread in all these people is that they’re interested in self-improvement,” Wexler says. “They’re in two camps. Some are interested in enhancing cognition, learning faster, performing better at memory tasks. And another group is interested in self-treating a variety of mood disorders.”

As Wexler discusses in one paper, appearing recently in the Journal of Medical Ethics, the people building their own devices for transcranial direct current stimulation (tDCS) have often invested substantial time looking at academic research on the subject, some of which suggests positive outcomes from brain stimulation. Their ranks are being joined by more casual consumers who can now purchase inexpensive devices to do the same thing.

Such products have produced a regulatory debate among academic researchers. The U.S. Food and Drug Administration (FDA) has not approved tDCS as a treatment for any malady. On the other hand, if such tools are marketed as helping generalized “wellness,” not as a cure for one problem, they may fall outside the FDA’s purview.

“There are a lot of blurry lines in food, drug, and cosmetic regulation,” observes Wexler, who presents the most comprehensive research overview yet written on the nuances of the regulation issue, appearing this fall in an article for the Journal of Law and Biosciences. “The definition of a medical device is not based on a definition of its action, but on how the device is intended to be used. And the FDA has historically judged intended use by manufacturers’ marketing claims.”

Wexler was also one of the experts asked to speak at an FDA panel held on the topic in November.

Gaining currency

Academic interest in tDCS gained currency after a 2000 paper by two German neurophysiologists showed that passing a weak electrical current through the motor cortex helped people perform motor tasks better. The volume of studies increased slowly for several years — about 100 in all through 2007 — but has shot up recently: There have been over 100 published studies in each of the last four years, with about 300 being published in 2014 alone. Several companies produce tDCS machines used in lab settings where such research takes place.

Researchers have not really reached a firm consensus on the effects of tDCS, however. As Wexler notes, “no serious adverse effects” have been found among 10,000 human subjects in academic research, but one study, published in the Journal of Neuroscience last year, found that tDCS appeared to impair cognitive function in at least some individuals. Still on the other hand, numerous studies do show some kind of functional cognitive enhancement due to tDCS.

Wexler’s original research on the do-it-yourselfers — what she terms the “DIY tDCS crowd” — in the Journal of Medical Ethics provides an initial demographic look at who they are. Wexler conducted interviews, and examined online videos, blog posts, and forums, and found that most of the people involved are male; come from one of three dozen countries; and include “at least a handful” of lab researchers.

“They do look to scientific papers and in a lot of ways they do follow scientific precedent,” Wexler says. “In other ways, they do their own thing.” For instance, because “there is no agreement on what level of tDCS is bad for you,” she adds, the DIY tDCS community reports a wide variety of usage patterns, from relatively light to heavy amounts of stimulation.

Image of a blue brain.

People building their own devices for transcranial direct current stimulation (tDCS) have often invested substantial time looking at academic research on the subject. “They do look to scientific papers and in a lot of ways they do follow scientific precedent,” PhD student Anna Wexler says. “In other ways, they do their own thing.” Image is adapted from the MIT press release.

Other scholars say Wexler’s work is original and significant. Her research into the DIY tDCS community is the “best encapsulation of the near-history of this phenomenon, which has really arisen in the last four to five years,” says Peter Reiner, a professor of psychiatry and expert in neuroethics at the University of British Columbia, who has also studied the issue. Reiner adds that Wexler’s “scholarship is excellent,” and observes that it is unusual for a graduate student to be looked to as a voice for policymakers.

The path ahead

In lieu of a complete scientific consensus on the effects of tDCS, however, it is not yet clear who should regulate the devices, let alone in what ways.

As Wexler puts it in the Journal of Law and Biosciences paper, there is not a “regulatory gap” pertaining to brain stimulation, but rather, “there are multiple, distinct pathways by which consumer tDCS devices can be regulated in the United States.” For example, they could be regulated not by the FDA but as regular consumer devices, subject to consumer safety and advertising laws under federal agencies like the Consumer product Safety Commission and the Federal Trade Commission.

Whatever path lies ahead, Wexler suggests regulators should follow an “open engagement” model of reaching out to the community of tDCS users to get a sense of the extent of use and the degree to which new guidelines are needed.

“I think the open engagement approach is just more practical,” Wexler says. “You can’t crack down on people building the devices. If anybody wants to go out and buy a battery and wires, it’s their right to do so.”

On the other hand, engagement with users, and perhaps a third-party review of tDCS effects by a group such as the National Academy of Medicine, would encourage at-home tDCS users to follow regulatory prescriptions rather than going their own way.

“We’ll have to wait and see,” Wexler says of the regulatory debate’s outcome. “But the DIY community really looks to scientific papers for guidance. They do value what scientists say.”

About this neuroethics research

Source: Peter Dizikes – MIT
Image Credit: The image is adapted from the MIT press release
Original Research: Full open access research for “A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States” by Anna Wexler in Journal of Law and the Biosciences. Published online October 12 2015 doi:10.1093/jlb/lsv039

Abstract for “The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals” by Anna Wexler in Journal of Medical Ethics. Published online August 31 2015 doi:10.1136/medethics-2015-102704


Abstract

A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States

Several recent articles have called for the regulation of consumer transcranial direct current stimulation (tDCS) devices, which provide low levels of electrical current to the brain. However, most of the discussion to-date has focused on ethical or normative considerations; there has been a notable absence of scholarship regarding the actual legal framework in the United States. This article aims to fill that gap by providing a pragmatic analysis of the consumer tDCS market and relevant laws and regulations. In the five main sections of this manuscript, I take into account (a) the history of the do-it-yourself tDCS movement and the subsequent emergence of direct-to-consumer devices; (b) the statutory language of the Federal Food, Drug and Cosmetic Act and how the definition of a medical device—which focuses on the intended use of the device rather than its mechanism of action—is of paramount importance for discussions of consumer tDCS device regulation; (c) how both the Food and Drug Administration (FDA) and courts have understood the FDA’s jurisdiction over medical devices in cases where the meaning of ‘intended use’ has been challenged; (d) an analysis of consumer tDCS regulatory enforcement action to-date; and (e) the multiple US authorities, other than the FDA, that can regulate consumer brain stimulation devices. Taken together, this paper demonstrates that rather than a ‘regulatory gap,’ there are multiple, distinct pathways by which consumer tDCS can be regulated in the United States.

“A pragmatic analysis of the regulation of consumer transcranial direct current stimulation (TDCS) devices in the United States” by Anna Wexler in Journal of Law and the Biosciences. Published online October 12 2015 doi:10.1093/jlb/lsv039


Abstract

The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals

Scientists and neuroethicists have recently drawn attention to the ethical and regulatory issues surrounding the do-it-yourself (DIY) brain stimulation community, which comprises individuals stimulating their own brains with transcranial direct current stimulation (tDCS) for self-improvement. However, to date, existing regulatory proposals and ethical discussions have been put forth without engaging those involved in the DIY tDCS community or attempting to understand the nature of their practices. I argue that to better contend with the growing ethical and safety concerns surrounding DIY tDCS, we need to understand the practices of the community. This study presents the results of a preliminary inquiry into the DIY tDCS community, with a focus on knowledge that is formed, shared and appropriated within it. I show that when making or acquiring a device, DIYers (as some members call themselves) produce a body of knowledge that is completely separate from that of the scientific community, and share it via online forums, blogs, videos and personal communications. However, when applying tDCS, DIYers draw heavily on existing scientific knowledge, posting links to academic journal articles and scientific resources and adopting the standardised electrode placement system used by scientists. Some DIYers co-opt scientific knowledge and modify it by creating their own manuals and guides based on published papers. Finally, I explore how DIYers cope with the methodological limitations inherent in self-experimentation. I conclude by discussing how a deeper understanding of the practices of DIY tDCS has important regulatory and ethical implications.

“The practices of do-it-yourself brain stimulation: implications for ethical considerations and regulatory proposals” by Anna Wexler in Journal of Medical Ethics. Published online August 31 2015 doi:10.1136/medethics-2015-102704

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