Tag Archives: foc.us

Should neuro-products be regulated like pharmaceuticals?

brain-pharma-happy-pills

This is not a joke. This is an actual product, on sale now at Amazon.com

For whatever reasons (fashion, new technology, an endemic dissatisfaction with the status quo) we appear to be entering the age of the mass-market neuro-product. Many neuro-businesses (such as the many varieties of ‘brain training’ products) are aimed at normal, healthy customers, however some of them tip over the line into what could arguably be called medical treatments. For instance Brain Balance Centers claim to treat a wide range of disorders including autism, ADHD and Tourette’s; conditions well-recognised and characterised by modern (clinical) science. These putative medical uses of technology (meaning technology in a broad sense, in that a set of developed therapeutic techniques such as Cognitive Behaviour Therapy might be considered a ‘technology’) are currently completely unregulated.

This legal situation stands in stark contrast to most other medical
treatments and devices which (even in the famously laissez-faire health care industry of the USA) are very rigourously regulated indeed. Pharmaceutical companies have to provide extremely robust evidence of the effectiveness, tolerability, side-effects etc. of their products, and expend a great deal of effort, time, and money collecting clinical trial data in order to do so. This is entirely as it should be; before a pharmaceutical product hits the market the regulators (the FDA in the US, the MHRA in the UK) need to be satisfied that the compound or treatment a) works as the company claims, and b) is relatively safe, when balanced against the potential benefits in the medical conditions it’s designed for. Even the mildest drugs (such as over-the-counter pain medication) have the potential for harm if misused, so this balancing of risks and benefits (backed up by hard evidence) is very important. This burden of regulation on the big pharma companies is pretty onerous, but it’s absolutely necessary in order to protect consumers and patients. Many have argued that the current regime is ineffective and are campaigning for even more oversight and accountability.

Should we not hold  neuro-products to the same standard? After all many of these companies claim their products directly affect the brain, just like psychoactive drugs. Whether they actually do or not is of course a matter of debate, and the hard data are generally lacking,

One could argue that the vast majority of, say, brain training products are relatively harmless, and that the worst potential outcome is that someone just wastes a lot of their time. This is probably true, and my purpose here is not to scare-monger about playing computer games (I’ll leave that to Baroness Greenfield). However other products do have a much greater potential for harm. The foc.us transcranial Direct Current Stimulation (tDCS) device (which I’ve written about before here) certainly falls into that category. This product claims to directly stimulate the frontal lobes through the application of electrical currents to the brain. The FAQ section of the foc.us website contains this:

“Is foc.us FDA approved?
No. The focus gamer headset offers no medical benefits, is not a medical device, and is not regulated by the FDA.”

So, what is it then? Is it classed as a toy? Does that mean it doesn’t really do anything? I wonder how long it will be before some bright spark decides to make a quick buck and starts marketing tDCS devices like this for particular medical conditions? (ADHD would be a popular choice.) In that situation it would seem that the position that these aren’t medical devices would be much harder to maintain. Mark my words; some dead-eyed, marketing-droid with a sharp suit and a howling abyss for a soul is probably preparing some material for a product launch like this as I type these words.

The line between medical and non-medical treatments has always been pretty shady, and open to interpretation. Many nutritional supplements are marketed as having medical uses, and some may even actually be effective. It seems to me that the neuro-businesses who are seeking to commercialise brain-altering products are somewhat hoist by their own petard: Either they admit that their products are essentially ineffective (and therefore not in need of regulation), or they maintain their claims about ‘changing the brain’ and submit to a pharma-style regulatory oversight (with all the enormous hassle and expense that involves). At the moment, the technology is running ahead of what lugubrious legal systems can keep up with, but if the regulators do decide to start paying attention, the neuro-companies may be forced to (at the very least) undertake a radical overhaul of their business model. The business that can’t substantiate their claims and show that their product is safe will be forced to withdraw them from sale, and this can only be a good thing for consumers.

Brain stimulation hits the mainstream – commercial tDCS device available soon for $249

Transcranial Direct-Current Stimulation is a technique that involves passing low-level electrical currents through parts of the brain. The effects of this are various, depending somewhat on the area being zapped, but it appears to change the baseline level of cortical excitability, and the effects can persist for several hours (or perhaps days) after a standard 20-minute session. People have been zapping themselves in the head pretty much since electricity was discovered, but tDCS in its modern form is a relatively new technique, and is thought to have potential for treating depression, stroke-recovery, and other clinical issues. It can also apparently lead to enhancements of normal functions (visual, motor, working memory, etc.) in healthy participants. The Guardian published an article this week on the effects of tDCS on maths ability, based on research which has been fairly widely criticised on Twitter.

This potential cognitive-enhancing effect is what’s caught the eye of a company called Foc.us, who are now offering a commercial tDCS system, for use by anyone at home, for $249 (or £179 in the UK). Here it is:

The foc.us tDCS headset

The foc.us tDCS headset

So, it’s a small band with a battery at the back, and four electrodes at the front that sit over the forehead. Foc.us are marketing this as a device for gamers to “Excite your prefrontal cortex and get the edge in online gaming.”

So – does it work? Possibly… But it almost certainly doesn’t do what the company says it does. For a start, if you want to “get the edge in online gaming” wouldn’t you want to stimulate your motor cortex (at the top of the head) and/or the visual cortex (at the back)? It’s unclear how stimulating the prefrontal cortex (behind the forehead) would give you an advantage in games. In fact, (as this article explains) placement of the electrodes over the dorsolateral prefrontal cortex is most often used for treatment of depression and chronic pain, so potentially these devices might have more of an effect on mood or emotions than any useful gaming-related functions. There is no information about effectiveness or effects on the  company website; the standard protocol of 1mA stimulation for five minutes is unlikely to do much beyond delivering a mild sensation on the scalp. The device can be configured to deliver up to 2mA (through a smartphone app), which may be enough to affect the brain.

Furthermore, there are important safety considerations for this kind of device. In fact, tDCS is such a recent technique that researchers are still in the process of working out what the safe limits actually are (in terms of both power delivered, and duration/frequency of stimulation). This article highlights the possibility that the electrodes can cause skin lesions, and tDCS can even potentially cause lesions in the brain  (admittedly in rats, and with currents a couple of orders of magnitude higher than used in humans). Still, potentially people could be using these systems repeatedly for long periods, and we have very little idea about what the effects of that might be.

If you’re still really intent on zapping your own brain to see if you can become an intellectual giant, or give yourself telekinetic powers or X-ray vision (hint: you won’t) then you could also build your own tDCS device using a 9V battery, some wire, a resistor and a couple of sponges, as described here. Total cost: about $5.

ABSOLUTELY DO NOT DO THIS. IT’S A FUCKING STUPID THING TO DO TO YOURSELF.

Passing electrical currents through the body can be fantastically dangerous. A (alternating) current as low as 10 MICRO-Amps can be enough to cause ventricular fibrillation and cardiac arrest, if passed directly across the heart,  current in the 10-20mA range causes severe muscular contractions, while 60-70 mA is usually fatal (source: Wikipedia).  Seriously, let’s leave passing electric currents through the body to the professionals, eh?

Many thanks to tDCS researcher Nick Davis for helpful discussions on Twitter related to this article.