Foc.us Labs

Wearable tech can track your sleep patterns, give you walking directions that float above your eye, and measure your heart rate using the shirt on your back. But can a wearable gadget make you think faster, or even make you momentarily smarter?

Turns out, it can. But only by attaching electrodes to your head that shock your brain, which is how devices like the Focus headset work. The Focus is designed for gamers --- only if you're 18 years old, or older -- and made headlines in May when its Web site opened for preorders. The Focus marks the first device of its kind, and it could bring what is now a cutting-edge enthusiast activity into the mainstream.

The unknown, however, is just how safe it might be to clamp this type of device to your head on a daily basis. So far, scientists have tested the technology, but mainly to figure out if it's effective. And creating a mass consumer product of this sort raises whole new concerns. The medical community remains wary, and the Focus headset may force an answer that dictates the future of consumer enhancement products.

The technique in question is called tDCS, for transcranial direct current stimulation, and it's a brain stimulation method that involves sending very low amounts of electrical current through various parts of the brain to achieve different effects. Historically it's been reserved for medical treatment, and it was first used as far back as 1804. Recent studies have determined that minor stimulation can have positive effects on healthy brains. For example, shocking the prefrontal cortex, as the Focus device does, is thought to improve learning and working memory, while shocking the motor cortex may raise one's threshold for pain and improve the use of one's nondominant hand.

It sounds too good to be true, and in fact tDCS is widely believed to have few, if any, side effects for short-term use. It's also painless. Research even shows that it does work; a study published in Neuroscience Letters last year outlines how 33 individuals attempted to solve a logic puzzle with and without tDCS; 40 percent succeeding using stimulation and zero without it.

Screenshot by Nick Stat/CNET.

The tDCS enthusiast community is also blossoming, especially considering that stimulation can be replicated with do-it-yourself electrodes and over-the-counter batteries, as this YouTube tutorial outlines. Dave Siever, a Canadian man whose company, Mind Alive, makes a $650 tDCS device, swears by the technique, claiming it has improved his sense of pitch and even works as an antidepression device.

These kinds endorsements, both from hobbyists and from the select scientific studies that have shown the positive effects of tDCS, have driven interest in stimulation as the next wave of human enhancement. But the science isn't keeping pace.

"I am concerned about the safety of allowing brain stimulation devices loose on the public, without prior efficacy or safety limits," said Mark George, director of the Medical University of South Carolina's Brain Stimulation Laboratory. "We need to proceed cautiously with brain stimulation."

What to know before 'overclocking your head'

For starters, brain stimulation is a wide-reaching term that can range from the seemingly harmless tDCS to the invasive and dangerous forms of deep brain stimulation that sometimes involve implanting electrodes directly in your head. These forms, reserved for those who suffer from medication-resistant depression and other serious forms of neurological disorders, are done with devices that must be FDA-approved, are vigorously regulated, and are operated within the safe confines of a lab with trained experts.

On the other hand, tDCS devices are not typically FDA-approved and their effectiveness varies depending on the types of equipment used and what kind of effects are being tested. That's what makes the Focus headset a particularly interesting test case for the future of consumer tDCS devices.

For one, it's fully formed, designed to look and feel like a futuristic device. The $250 headset, which is not FDA-approved because it is not marketed as a medical device, sends anywhere from 0.8 to 2.0 milliamps of electrical current to your prefrontal cortex for 10 to 40 minutes. (To put that in perspective, a 100-watt lightbulb on a 120 volt supply, which is more than ten times the recommended voltage for powering a tDCS device, puts out roughly 830 milliamps of electricity.)

The result, the company claims, is a smarter, faster, better you. "Overclock your head," reads one of the energetic tag lines.

Focus Labs

"We did a fairly broad review of the current state of scientific knowledge regarding tDCS," said Michael Oxley, Focus' founder. "In science it's rarely the case that one can base a conclusion on one (or even a few) particular studies or publications (of studies) -- or the views of a single (or even a few) researchers. We were given a few starting points by academic contacts and took it from there."

For safety consultation when designing the Focus headset, Oxley provided a 2007 study on rats from Germany's University Medical Center Göttingen that that outlined a potential threshold for current amounts using tDCS before the animals developed lesions. The researchers found it likely humans could safely withstand small amounts of electricity, though they concluded that "further animal studies are required, before such protocols can be applied in humans."

Oxley also cited a 2009 study on humans from Georg-August University in Germany, which included this mild caveat: "Our results suggest that tDCS applied to motor and non-motor areas according to the present tDCS safety guidelines, is associated with relatively minor adverse effects in healthy humans and patients with varying neurological disorders."

"I am concerned about the safety of allowing brain stimulation devices loose on the public, without prior efficacy or safety limits." <br>--Mark George, Medical University of South Carolina

The company also took measures to diligently test the device because, while not a medical tDCS unit, it does have physiological effects, which range from mild tingling to lasting burning sensations and potential headaches and mood changes as one online user described. "The testing was independently assessed and verified by a UK test centre. Foc.us also had to pass FCC testing requirements due to the included bluetooth connectivity and other CE testing requirements," Oxley wrote.

But Amit Etkin, an assistant professor of psychiatry and behavior sciences at Stanford University, will tell you flat out that tDCS likely is not dangerous, as Oxley's cited studies suggest, but also that the issue is not about immediate safety concerns. Rather, the potential with tDCS is simply unknown.

"It's true that tDCS has been used in studies and even shown substantial positive effects on patients," said Etkin, whose clinic specializes in transcranial magnetic stimulation, a depression treatment that is highly regulated and poses a slight risk of seizure. But, he noted, "The worst-case scenario is that a bunch of users who don't have specific instructions will use it in a variety of different ways and alter their brains in ways that they don't anticipate and we don't anticipate."

The Focus headset has built-in measures designed to prevent misuse. Its iOS app lets you control, among other things, the current level and the duration of the shocks. But what's to keep an avid gamer from running the Focus headset, which is meant to be used up to 40 minutes, for two hours, or even longer?

After all, telling a pumped-up teen who thinks he's now a better gamer to slow down would be like asking a frat member to drink responsibly. "Most likely, it will be fine," Etkin said. The trouble, he added, is that the "potential harm" is unknown and, hence, of "quite significant" concern.

Update, 9:19 a.m. PT: Clarified milliamp output of the Focus headset when compared with a standard 100-watt lightbulb.