Transcranial direct-current stimulation – don’t try it at home

“Many Shubs and Zulls knew what it was to be roasted in the depths of the Sloar that day I can tell you.”

I’ve written before about tDCS and in particular the device produced by a company called foc.us; a company marketing a tDCS device to gamers. As a brief recap, tDCS involves passing a low-level electric current through your brain, and thereby attempting to stimulate particular regions of the cortex in order to enhance particular functions. Academics have been using this (and similar) method for a while now, and showing some interesting effects in all kinds of motor, sensory and cognitive domains (for a fairly broad review see here; PDF).

When academics perform this procedure on their experimental subjects for the purposes of research they have to get clearance from an ethical review board first, and they observe strict limits in order to ensure the safety of their participants, both in terms of the time they stimulate for, and the amount of electrical current they use. However, there is a community of amateur tDCS enthusiasts, who build their own equipment and zap their brains at home. If this sounds like a spectacularly bad idea, you’d be dead right. These guys (and let’s face it, it’s usually guys) naturally aren’t bound by the same safety rules; the only limit is their own stupidity.

TDCS appears to be becoming more mainstream, with commercial products like the foc.us headset and positive write-ups in media outlets (like this one and this one) helping to raise the profile of what has been up until now, a pretty niche activity. This BBC report focuses on the military applications of the technology and proclaims that the US military are ‘very interested in its potential’. Yeah, well… the US military also ran a 20-year research program into remote viewing and other psychic phenomena (only discontinued in 1995!) so let’s not put too much faith in their ability to spot obvious bollocks.

The point I want to get across here is that DIY-tDCS is not only pretty unlikely to actually do anything useful, but can also be potentially extremely dangerous. I know, right? Who’d have thought that passing electric currents through your brain might be a problem? The tDCS sub-reddit page is full of horror-stories ranging from people suffering electrode burns (like this guy) to this story of a user suffering crippling anxiety, panic attacks and depression for more than a year after tDCS. Whether the tDCS actually caused these fairly extreme symptoms in this particular case is somewhat debatable, and probably unknowable, but the point is that relatively severe adverse events can, and do happen with these devices. Most worryingly of all, there’s a report here on the electrical safety of the commercial foc.us device, which suggests that it doesn’t perform in the manner it specifies in terms of regulating the voltage, and can cause skin burns. This user claims to have suffered severe migraine-like pain after a session with the foc.us device.

To sum up:

Do not pass electrical currents through your head! It is a bloody stupid thing to do.

Seriously, if you want to give yourself some kind of an ‘edge’ in gaming, or studying, or whatever, just have a quadruple espresso – much safer and more effective.

Thanks to @neuroconscience for pointing out the tDCS horror-stories on Reddit.

 

How to develop and market your neuro-product

You were only supposed to blow the bloody occipital cortex off.

The human brain is fast becoming a new frontier for business. Neuromarketing, ‘brain-training’ companies, and therapeutic programs that contain some kind of neuro-twist are proliferating at a very high rate.  Somewhat more disconcertingly, a couple of new products actually aim to make a more direct interface with your brain. ‘Melon’ (currently getting funded on KickStarter) is a headband that measures your EEG signal in order to help maintaining focus on tasks, and a company called foc.us is currently marketing a trans-cranial Direct Current Stimulation (tDCS) device that claims to directly modulate brain activity in the frontal lobes by the use of electric currents. In case you’re wondering about that last one, then yes, it’s absolutely as terrifying and ill-advised as it sounds. At the other end of the scariness/lunacy/class-action-lawsuit-waiting-to-happen scale are relatively harmless products like ‘Neuro’ energy drinks, or Neurozan dietary supplements.

So, neuro-business is definitely becoming a thing, and it’s a safe bet that we can expect to see many more products of this type in the future. But there’s a problem: the neuroscientists. Those slightly weird, often scruffily dressed, usually somewhat nerdy people who spend their time in basement labs and only occasionally emerge blinking into the sunlight to pour buckets of cold cerebrospinal fluid over perfectly legitimate business ideas and marketing campaigns. “Where’s the evidence?” they whine, mostly to other neuroscientists on Twitter, or on blogs like this one that no-one else reads. “Show us the data” and “Does it really work?” they screech, incessantly.

So, maybe you’ve got an idea for a hot new brain-mangling device, or a new twist on the brain training band-wagon. Maybe you’ve even got a new therapy technique that you’ve lovingly crafted over years of working with special-needs children, that you genuinely believe could make a profound and lasting difference to people’s lives, and that you’re just itching to share with the world. That’s great! But what can you do to ensure you’re not harassed by hordes of killjoy brain-botherers as you develop and market your product? Presented below is a handy guide to doing neuro-product-development the right way. Follow this simple process, and grateful, happy customers will be throwing big piles of cash at you before you can say ‘rostral orbito-frontal para-cingulate gyrus’.

1. Evaluate your product. Really evaluate it.
This is the big one. This is the Manhattan Project, the Everest, the Moon-shot, the X prize. I’m not going to lie to you; it’s not going to be easy, or fast, or cheap, but if you’ve got a product that you really believe in, don’t you owe it to your investors and customers to do everything you can to show that it works? Of course you do.

What you need to do in most cases is conduct a Randomised Controlled Trial (RCT) of your product. The ‘randomised’ bit means that participants are assigned to each group at random and the ‘controlled’ bit indicates that typically a product or treatment is compared against a placebo, or sometimes against an existing active product (both can be ‘control’ conditions). The trial should be well-powered (meaning it should have an adequate number of people in it to be able to demonstrate the hypothesised effect) and ideally double-blinded (meaning that neither the participants, nor those administering the tests, should know whether they are in the ‘active’ or ‘placebo’ groups).

Running a well-conducted RCT is not a trivial task; fortunately help is available. Contract Research Organisations (CROs) will run the trial for you. This is certainly the fastest way of getting it done, but probably also the most expensive. Another way might be to find a friendly academic who works in a research field related to your product, and get them to do it for you. Many academics are desperate for cash and would be only too happy to get some industry funding to run a research project. You may need to stump up enough money to employ a research assistant for the duration of the project, it might take some time, and they’re unlikely to be quite as professional about it as the CROs, but they definitely have the skills and experience needed to do a good job. This also has the added benefit of being an (at least nominally) independent evaluation; for added scientific credibility points you could even sponsor studies at more than one academic institution, using different participant samples, in different locations.

2. Make the results public
What’s the point of conducting a fantastic piece of research if nobody ever knows about it? You need to publish your findings in a peer-reviewed scientific journal. If you’re doing it in collaboration with academics, they’ll definitely want to do this anyway, so it’s a win-win for all concerned. Ideally, you would also make all the raw data from the trial available and freely-downloadable from your website; that way you can get further (free!) verification of your results from data-nerds who like playing with that kind of thing.

3. Market it on the basis of your data
So you’ve done the testing, you’ve published the results; you’re ready to go! I know it’s probably all very exciting at this point, but you need to take a couple of deep breaths and tread carefully. All the hard work you’ve put into testing your product will be a waste of effort if you don’t stick closely to the results in your marketing. Don’t make wild claims about the product’s effectiveness that aren’t supported by the data. Don’t claim that it’s effective in treating say, autism, when you’ve only actually tested it on an ADHD population. Don’t say that it can boost performance in healthy people when you’ve only tested it on a patient group. Any claims you make that go beyond what you can actually prove will only hurt you in the long run, and will bring down the wrath of the neuro-nerds.

This approach might seem laborious; it’s the kind of procedure that pharmaceutical companies have to go through when making licensing applications to the FDA for new drugs. Neuro-products are lightly regulated at the moment because it’s very new, so there’s no legal obligation to do anything. However, if some of them really can change the brain in a meaningful way, shouldn’t they be held to the same standard as psychoactive drugs? At least there’s a moral obligation there, if not (yet) a legal one.

Doing due diligence in terms of product evaluation also serves to mitigate what I like to call the penis enlargement problem. For the sake of argument, let’s suppose that someone has invented a treatment that can genuinely enlarge penises. This hypothetical treatment is safe, effective, and works in 100% of men. Unfortunately, no-one will ever know about it, because of the enormous number of bogus penis-enlargement treatments that are promoted in spam emails and pop-up ads all over the internet. Proving your product is effective in the most rigorous way possible, and freely publishing the results and the data is the most effective way of differentiating your business from the hordes of phony neuro-products (of which there are many) out there.

Alternatively, if this all seems like too much of a bother, you can just re-cycle some old therapy techniques using new jargon, or bolt together some old academic research with a piece of new technology. Hire someone to make a really slick website, stick some fake customer testimonials up there and start selling a product that doesn’t really work, and may even actually be dangerous. You won’t be alone; that’s pretty much what everyone else is doing at the moment.

A handy flow-chart to illustrate the simple 3-step process of neuro-product development.

Should neuro-products be regulated like pharmaceuticals?

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.