May 4, 2017 | Written by: Morgan Childs
Categorized: New Thinking | Technology
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Dr. Brett Wingeier has thought of everything. In late April, he demonstrated the design functionality of Halo Sport, a pair of headphones that purports to stimulate the brain’s motor cortex to “prime” it for an optimized workout. Along the inside of the band is a plot of soft electrodes that sink into hair and press against the top of the skull to deliver a steady stream of electrical current. And while it doesn’t look like much, that row of nubby sponges is one of the innovations that have set Halo apart from a growing pack of at-home neurostimulators. “This was a huge part of the usability, because people have hair. Not everybody looks like me,” Wingeier said drolly. (His own head, by genetics or by design, provides something of a blank canvas for electrode placement.)
The thoughtfulness of Wingeier and his Halo Neuroscience co-founder Dr. Daniel Chao has not gone unnoticed. Dr. Marom Bikson, a biomedical engineer and CEO of neuromodulation leader Soterix Medical, praised the company for its innovative means of positioning electrodes and delivering current, among the “hundred other clever things” that contribute to the product’s functionality in stimulating the part of the brain primarily responsible for sending signals to the body to execute movement. Wingeier, Bikson said, “wants to do the right thing.” “That’s what people need to realize about these companies,” he added. “You may criticize them, but the ones which are the good ones are trying to do something, trying to make the world a better place.”
Unless you’re familiar with transcranial Direct Current Stimulation, or tDCS, the technology behind Halo may sound like pseudoscience—or worse, like a scene out of One Flew Over the Cuckoo’s Nest. But Wingeier and Chao aren’t alone in putting their faith in tDCS and other methods of non-invasive brain stimulation, which companies like theirs believe can enhance focus, improve sleep, and even ameliorate a host of physical and psychological ailments from Parkinson’s to epilepsy to tinnitus. Today, consumers looking to improve their quality of life with a targeted zap of electricity have an abundance of over-the-counter devices to choose from, thanks, in part, to the popularity of fitness trackers and other wearables that have put easy-to-use health technology directly in the hands of everyday people. And for companies like Halo that believe in this technology to exact real, measurable benefits to their consumers, these devices also have the potential to push the science behind tDCS and other neuromodulation techniques, possibly to the benefit of the greater medical community.
It isn’t that neurostimulation has shed its stigmatized association with electroconvulsive therapy entirely, or even that the scientific community is in agreement about the efficacy of the technique. A 2015 meta-analysis of 59 tDCS studies found no evidence of its cognitive effects in healthy adults, though proponents of the technique have taken issue with the review’s methodology; more recently, an analysis commissioned by the European Chapter of the International Federation of Clinical Neurophysiology including only repeated, placebo-controlled trials found “probable efficacy” for tDCS in treating fibromyalgia, depression, and addiction. Its authors noted, however, that it “remains to be clarified whether the probable or possible therapeutic effects of tDCS are clinically meaningful.”
But so far, tDCS also doesn’t appear to do any lasting harm, and according to its adherents, its possible applications are vast. The low-level electrical current delivered by tDCS alone isn’t enough to cause neurons in the brain to fire when they otherwise wouldn’t; rather, proponents of the treatment claim that it alters the connections between synapses in order to increase, or sometimes decrease, their chances of firing. Many tDCS users cite no physical feeling at all during stimulation, or only a tingling sensation at the electrode site, and many have described the immediate effects of the electrical current meted out by an OTC neurostimulator as something akin to the focusing power of a cup of coffee or the disinhibiting effect of a glass of wine. Halo, which has partnered with high-visibility professional athletes to test and promote its first product, has self-reported consistent performance improvement within trial groups from the MLB to the NFL.
Just five years ago, the landscape for neuromodulation devices looked quite different than it does today. In 2013, a New York Times trend piece on the use of tDCS looked to the YouTube videos and Reddit threads of neurostimulation DIYers for evidence that at-home brain stimulation was enjoying something of a moment. (Crude tDCS devices can be fashioned out of a nine-volt battery and a pair of kitchen sponges soaked in a saline solution, although at-home experimentation is strongly discouraged.) One pair of YouTubers that gained some media attention later sold the name of their aborted product to London-based developer Foc.us, whose founder Michael Oxley began to construct his own neurostimulation devices after reading about tDCS in New Scientist. “We knew it was good for working memory, for vigilance, so it was, ‘Okay, which group of people are going to see benefits from increased working memory and vigilance?’” Oxley recalled. “Gamers seemed a realistic target market.” Until recently, the original GoFlow gaming headset was perhaps the most visible of only a few direct-to-consumer neurostimulation devices available in the United States.
But by the summer of 2015, neuromodulation had indeed become relatively au courant. Socialite Susan MacTavish Best hosted a salon at her San Francisco home to honor the launch of Thync, a device that uses a modified method of transcranial stimulation to deliver more consistent results than traditional tDCS. At the event, Thync’s “Vibe Squad” and their guests feasted on pork belly candy and “a vast gourmet menu”; rock-jazz pianist and “longtime Thync user” ELEW provided entertainment. Last year, Halo announced that a handful of Olympic athletes had been training with the headphones in preparation for the games in Rio, and later, that the product was being used on the fields of the NFL. And this March industry stalwart Fisher Wallace Laboratories, maker of the prescription-only Fisher Wallace Stimulator, crowdfunded their second product in nearly three decades: Kortex, a sleek black neurostimulation device that can be used alone or slipped onto the back of a VR headset. (Both Fisher Wallace devices use another method of applying electricity to the brain, Cranial-Electro Stimulation, rather than tDCS.)
Isy Goldwasser, CEO of Thync, described the proliferation of devices as the result of a sort of perfect storm of consumer desires. “Whether it’s neurostimulation or the perfect pill or the perfect way to meditate, everyone is looking for the right and best,” Goldwasser said. “What’s the best way I can just steal away from what I feel so I can get everything in my life done? I think that is the whole point of this: technology can play a role for the first time in how you feel.”
Fisher Wallace received FDA clearance to treat depression and insomnia in 1990, just in time for pharmaceuticals like Lexapro, Prozac, and Paxil to crowd it out of the market, co-founder Kelly Roman said. But by the late-aughts, Dr. Richard Brown, a professor of psychiatry at Columbia University who had prescribed the device to over 200 patients, agreed to attest to its efficacy at a series of private events for New York psychiatrists in the Upper East Side home of co-founder Charles Wallace. Applying a “Tupperware-party model” to promote the product worked, Roman explained: by the end of 2010, the company had made enough revenue to begin to invest in an aggressive online advertising strategy, mostly on Facebook and Google.
Today, Fisher Wallace hopes its legacy as a medical device company will lend credence to Kortex, an over-the-counter brand employing the same technology at a lower dose. “Now that we’re doing our first OTC brand with Kortex, which we’re pairing with VR, the dividends of that strategy are really going to be felt,” Roman said. “Because we can say that this is the same technology as our medical brands—we can’t make the same claims, but we’re allowed to say it’s the same technology.” Fisher Wallace is marketing the product as a means of combating stress and improving sleep, but it’s leaning on existing research on the efficacy of using virtual reality to treat disorders like PTSD and phobia, emphasizing its potential to improve the lives of military veterans.
“Ultimately it’s just a way for more people to be treated,” Roman said. The original Fisher Wallace Stimulator is already available over-the-counter in many countries around the world, and Roman believes that a combination of neurostimulation, virtual reality, and electroencephalogram monitors to track brain wave activity could cut slash treatment costs for PTSD, substance abuse, anxiety, phobias, and ADHD in the United States. “That’s what’s really getting me up in the morning,” Roman said.
Wingeier recalls that he and Chao were inspired by the same untapped possibilities. “When we started Halo, we knew that there was this science-based technology with a lot of potential, but nothing ever feels right until you kind of map it out yourself,” he recalled. In the first year of its existence, the company primarily functioned as a research incubator. But Wingeier and Chao challenged themselves to develop a practical application for their insights in order to make tDCS an integral part of everyday life. Wearable technologies that interact with the body are more acceptable now than ever, Wingeier said, but “that doesn’t mean that it’s an easy road.”
The Go Flow tDCS Stimulator from Foc.us uses electrodes attached to a customized baseball cap.
“Frankly, this is brain stimulation,” Wingeier said. “There’s a lot of parts to the question of making that more comfortable for people. … And there’s a long history of everything from great science fiction to horror stories out in the popular culture about anything that interacts with the brain. So it’s a huge journey trying to make a product that fits into people’s lives and makes this real, makes this acceptable.”
Halo’s co-founders devised a practical, non-threatening application for the technology by enhancing a commonplace consumer product: a pair of headphones. The headband of the Halo Sport sits directly above the brain’s motor cortex (or as Wingeier called it, “the sweet spot”), and the device is operated via iOS or Android app. The whole thing resembles a pair of upscale headphones, and indeed, athletes can use it to listen to music, including during a priming session. Unlike depression or anxiety, movement is easy to measure and quantify, providing an attractive first foray into consumer devices for a company still seeking to prove the efficacy of its own product. And like Thync and many other companies working with tDCS, Halo conducts its own research to develop and promote its technology.
As Bikson, who also conducts clinical trials of tDCS devices at Soterix, explained, many of the symptoms and afflictions these devices purportedly ameliorate fall within a continuum—between imperfect sleep and insomnia, for example, or between lack of focus and ADHD. While regulation agencies like the FDA can limit the claims companies can make about their consumer devices, the technology is the same whether it’s being used at home or in a doctor’s office, even if, like the Fisher Wallace Kortex, at a considerably lower dosage. “The consumer companies are simply the ones that are not making medical claims, and the medical device companies are the ones making medical claims, and they could literally be selling the exact same device,” Bikson said. “Consumer companies push technology forward very quickly. And so what Halo was able to accomplish, what Thync was able to accomplish, was really in my opinion remarkable.”
Today, Halo has launched a feasibility study into stroke rehabilitation using tDCS, with long-term hopes of applying the technology medically to treat disorders like clinical depression, PTSD, and chronic pain. On the consumer side, Wingeier says, “the brain does a lot of things other than movement, obviously. There’s good data out there in things like learning, attention, focus, vigilance, cognitive control, things like that. It’s an amazing wide world out there with great data, and we’re looking forward to diving into all of it.”
Bikson insists that research on tDCS “dosing”—including the placement of electrodes, level of current, and duration of use—is far from complete. But despite gaps in understanding how best to apply tDCS, he believes its potential is worth exploring, with caution. “I’m not in the business of personally endorsing people to get treatment, but what I can do is I can point people to the literature,” Bikson said. “There are things out there that are investigational. … That doesn’t mean it works, that doesn’t mean it doesn’t work. That means the jury is still out. But there is data out there.”