Category Archives: Products

The NeuroBusiness 2015 Conference

51CWieSlleL._SY344_BO1,204,203,200_Last week there was a conference in Manchester titled NeuroBusiness 2015,  billed as the ‘first of its kind in the UK’. Actually the ‘neuroleadership‘ guys have been doing similar stuff for ages. They have some serious conceptual issues, and there’s also an excellent piece on TheConversation.com about neuro-quackery in business and education. NeuroBusiness 2015 took it to a whole new level though. On the front page of their website there’s a quote from Professor Dame Nancy Rothwell, President and Vice Chancellor of the University of Manchester, which reads:

“I very much welcome the opportunity to bring neuroscientists together with business.”

This is a noble aim, but apparently no-one let the conference organisers know about it, as browsing the list of speakers quickly reveals that there were no neuroscientists invited. None. The closest we have is Dr Jenny Brockis who appears to be a medic who found a more lucrative calling in Brain-fitness-related motivational speaking (*yawn*) and Dr Paul Brown, a clinical psychologist who has…. let’s say, an ‘interesting’ background, with various academic appointments in South-East Asia. Dr Brown is also the author of the book ‘Neuropsychology for Coaches’, the title of which suggests he doesn’t really know what the term ‘neuropsychology‘ refers to. Unless of course it’s a book for American Football coaches who have to deal with regular traumatic brain injuries in their players, which I doubt.

Anyway, I’ve no idea if the conference was a roaring success or not, since, as a neuroscientist, I wasn’t invited. What I do know is that it turned into an utter debacle on Twitter. Conference attendees started tweeting nonsensical things like:

“Hack your brains dopamine to become addicted to success!”

or

“Men’s brains fire back to front, women’s fire side to side. That’s why women multi task well”

…and the neuroscientists on Twitter quickly and gleefully piled on with sarcasm, jokes and general rubbishing. At one point it became really rather difficult to detect which were genuine #neurobusiness2015 tweets and which were fake sarcastic ones. I did notice there were significantly less tweets from the conference on day 2 – was some announcement made? It was all jolly good fun for us neuroscientists, but I did start to feel a bit sorry for the conference organisers at some point.

However, I have a suggestion. One which would prevent something like this happening again. If any of the conference organisers happen to be reading this, my suggestion for NeuroBusiness 2016 (if it happens) is this:

INVITE SOME NEUROSCIENTISTS. People who actually know something about the brain. Some of us are actually quite engaging speakers, who would relish the opportunity to emerge from our dark basement labs, and spend a day interacting with normal people. We’re not all massive nerds, obsessed with the abstract minutiae of our particular area of research. Well… I mean, we actually are, but that doesn’t mean we can’t function normally as well. Some of us even like to think about how neuroscience can be applied in every-day life too. Just have a look around at people’s CVs and publications, and pick a few good ones. Or have a look on Speakezee, or even just send me an email through this site, and I’ll send you a list of suggestions.

Business people – it’s great that you’re interested in the brain. We get it. We are too, that’s why we do what we do. Unfortunately there are a lot of people out there who have realised that sticking the neuro- prefix on some old load of bollocks is a jolly good whizz-bang way to make loads of money on the motivational speaking circuit. If your computer breaks, you wouldn’t call a motivational speaker, would you? You’d call an IT expert. If you want to know about the brain – ask a neuroscientist.

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Porsche take EEG marketing bollocks to the next level

hank-moody-porsche

The only cool guy who ever drove a Porsche. EVER.

The arrival of cheap, portable EEG (electroencephalography) equipment in the last ten years has been a bit of a mixed blessing. On the one hand, you have initiatives like the OpenEEG project, which has democratised access to good-quality EEG hardware and software for researchers and hobbyists. On the other you have a huge proliferation of neuromarketing companies using the technology in (often) ridiculous ways.

Up until yesterday, my favourite example was this from Red Bull, who tried to record the brain activity of surfers with some waterproofed EEG gear. However, a video recently released by Porsche just took it to a whole new level. Porsche is the well-known midlife-crisis-enabling company that makes expensive toys for micro-phallused executives, but they clearly have ambitions to make a splash in the world of neuroscience with their latest stunt. Here’s the video:

…in which a test subject is first strapped into a jet fighter, and then a Porsche on a racetrack while his brain activity is putatively monitored in real time by a scientist. The claim is that pulling G’s in a Porsche is (nearly) as exciting as being in a jet fighter doing aerobatics.

There is so much wrong with this, that we could be here for hours, but let’s just pick a few of the major issues:

1. The video implies that the EEG monitoring is in real-time i.e. while the subject is up in the aircraft, or in the car. I don’t know what wireless protocol they’re using for that, but it’s definitely not one I’m familiar with.

2. They claim to be monitoring activity from the nucleus accumbens, a fairly deep brain nucleus, part of the basal ganglia, and a key component in the brain’s reward circuitry. Surface (scalp) EEG is really only good for recording activity from the surface of the brain (the cortex). I can’t find any human EEG work that claims to get signals from the nucleus accumbens, and I’d be very surprised if it were even possible (EEG’s not my area though, so feel free to correct me in the comments if I’m wrong on this one!).

3. Even if it were possible to get signals from the accumbens, they claim to be measuring dopamine release. No. NO. EEG measures the electrical activity of the brain. That’s it. This is a flat-out lie.

4. The subject’s head is banging around like crazy in both situations, and he’s gurning like Bez in the 90s. As this video very clearly shows, you get huge EEG artefacts just by smiling, or moving your eyes around, so the EEG data they’re recording must be absolute crap.

5. The putative ‘scientist’, Dr Robert Van Der Linden, who conducts the tests doesn’t actually seem to exist. I can’t find any evidence of him anyway. Is this guy just an actor?

6. For the fighter jet segment the subject’s helmet actually has ‘Maverick’ on it, FFS.

For more neurotwattery see the accompanying website, which has the marvellous tagline “The cars that will stimulate your prefrontal cortex”. I… just… can’t even.

Commercial fMRI neurobollocks – no, you cannot record your dreams (yet).

Cash cow? No.

Cash cow? I wish! But no.

With thanks to Micah Allen (@neuroconscience) for pointing this one out.

My day job is as an fMRI (functional magnetic resonance imaging) researcher, so you can imagine how tickled I was when I came across a brand-new neurobollocks-peddler who’s chosen to set up shop right on my patch!

Donald H. Marks is a New Jersey doctor who in 2013 set up a company called ‘Millennium Magnetic Technologies’. Readers old enough to remember Geocities sites from the mid-90s will probably derive some pleasant nostalgia from visiting the MMT website, which is refreshingly unencumbered by anything so prosaic as CSS. Anyway, MMT offer a range of services, under the umbrella of “disruptive patented specialty neuro imaging and testing services”. These include the “objective” documentation of pain, forensic interrogation using fMRI, and (most intriguingly) thought and dream recording.

This last one is something that’s expanded on at some length in a breathlessly uncritical article in the hallowed pages of International Business Times (no, me neither). According to the article:

“The recording and storing of thoughts, dreams and memories for future playback – either on a screen or through reliving them in the mind itself – is now being offered as a service by a US-based neurotechnology startup.

Millenium Magnetic Technologies (MMT) is the first company to commercialise the recording of resting state magnetic resonance imaging (MRI) scans, offering clients real-time stream of consciousness and dream recording.”

And he does this using his patented (of course) ‘cognitive engram technology’, and all for the low, low price of $2000 per session.

It’s clear from the article and the MMT website that he’s using some kind of MVPA (multi-voxel pattern analysis) technique with the fMRI data. This technique first came up about 10 years ago, and is based on machine learning algorithms. Briefly, an algorithm is trained, and ‘learns’ to distinguish differences in a set of fMRI data. The algorithm is then tested with a new set of data to see if what it learned can generalise. If the two sets of data contain the same features (e.g.the participant was exposed to the same stimulus in both scans) the algorithm will identify bits of the brain that contain a consistent response. The logic is that if a brain area consistently shows the same pattern of response to a stimulus, that area must be involved in representing some aspect of that stimulus. This family of techniques has turned out to be very useful in lots of ways, but one of the most interesting applications has been in so-called ‘brain-reading’ studies. In a sense, the decoding of the test data makes predictions about the mental state of the participant; it tries to predict what stimulus they were experiencing at the time of the scan. A relatively accessible introduction to these kinds of studies can be found here.

So, the good Dr Marks (who, by the way, has but a single paper using fMRI to his name on Pubmed) is using this technology to read people’s minds. However, needless to say, there are several issues with this. Firstly, to generate even a vaguely accurate solution, these algorithms generally need a great deal of data. The dream decoding study that MMT link to on their website (commentary, original paper) required participants to sleep in the MRI scanner in three-hour blocks, on between seven and ten occasions. Even after all that, the accuracy of the predictive decoding (distinguishing between two pairs of different stimuli, e.g. people vs. buildings) was only between 55 and 60%. Statistically significant, but not terribly impressive, given that the chance level was 50%.

My point here is not to denigrate this particular study (which is honestly, a pretty amazing achievement), it’s to make the point that this technology is not even close to being a practical commercial proposition. These methods are improving all the time, but they’re still a long way from being reliable, convenient, or robust enough to be a true sci-fi style general-purpose mind-reading technology.

This apparently doesn’t bother Dr Marks though. He’s charging people $2000 a session to have their thoughts ‘recorded’ in the vague hope that some kind of future technology will be able to play them back:

“The visual reconstruction is kind of crude right now but the data is definitely there and it will get better. It’s just a matter of refinement,” Marks says. “That information is stored – once you’ve recorded that information it’s there forever. In the future we’ll be able to reconstruct the data we have now much better.”

No. N. O. No. The data is absolutely, categorically not there. Standard fMRI scans these days record using a resolution of 2-3mm. A cubic volume of brain tissue 2-3mm on each side probably contains several hundred thousand neurons, each of which may be responding to different stimuli, or involved in different processes. fMRI is therefore a very, very blunt tool, in terms of capturing the fine detail of what’s going on. It’s like trying to take apart a swiss watch mechanism when the only tool you have is a giant pillow, and you’re wearing boxing gloves. A further complication is that we still have so much to learn about exactly how and where memories are actually represented and stored in the brain. To accurately capture memories, thoughts, and even dreams, we’ll have to use a much, much better brain-recording technology. It’s potentially possible someday (and that ‘someday’ might even be relatively close), but the technology simply hasn’t been invented yet.

So, the idea that you can read someone’s mind in a single session, and preserve their treasured memories on a computer hard disk for future playback is simply hogwash right now. I’m as excited by the possibilities in this area as the next geek, but it’s just not possible right now. Dr Marks is charging people $2000 a pop for a pretty useless service, no matter how optimistic he might be about some mythical kind of future mind-reading playback device.

NB. I’ve got a lot more to say about MMT’s other services too, but this post’s got a bit out of hand already, so I’ll save that for a future one…

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."

“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.

 

You keep using this word ‘neuroplasticity’. I do not think it means what you think it means.

mp2

So, I wanted to write a post about how the word ‘neuroplasticity’ is  the current neuro-bullshitter’s favourite big sciencey-sounding word to throw around these days. I was going to explain how it was actually such a broad umbrella term as to be pretty meaningless, and talk about some things like LTP and synaptogenesis in the hippocampus which (in contrast) are precise, well-defined terms, and fascinating processes, and how your brain is changing in a ‘plastic’ manner even as you read these words. It was really going to be a great post.

Unfortunately (as so often seems to happen), it turns out that the mighty Vaughan Bell beat me to it by a scant three years with this typically outstanding post on mindhacks.com. So. I guess you should all just go and read that instead, and I’ll have to be content with my standard operating procedure and take the piss out of some quacks instead.

The ‘About the Science’ section of the Brain Balance Centers main website has some awesomely meaningless language, that manages to work in some other big sciencey-sounding word too:

“It was once thought that the brain was static, unable to grow or change. But extensive research and in depth study of epigenetics has shown that it’s remarkably adaptable, able to create new neural pathways in response to stimulus in the environment, a branch of science called neuroplasticity.”

Ooh – epigenetics, and neural pathways. Fans of meaningless brain cartoons should definitely check out that site too, their disconnected vs. connected diagram is fabulous.

The Lumosity website (a brain-training company) has some pretty choice language too:

“But when neuroplasticity’s potential is thoughtfully and methodically explored, this physical reorganization can make your brain faster and more efficient at performing all manner of tasks.”

There are lots of other examples I could paste in here. I spend a fair amount of time looking at these companies’ sites and I’ve come to the conclusion that any mention of the word ‘neuroplasticity’ is basically a massive red-flag. People are very fond of using it to promote these things, but mostly their arguments boil down to “Because: neuroplasticity!”, which as Vaughan explained so eloquently, doesn’t mean anything at all without a whole additional layer of explanation, refinement and qualification.

So – a top tip, when you see the word ‘neuroplasticity’ think ‘bollocks’ instead.  99% of the time you’ll be absolutely dead-on.

Can playing video games improve general cognitive function?

UnknownThere’s been a lot of discussion this week about a new article in Nature by Anguera et al. titled “Video game training enhances cognitive control in older adults”. This paper appears to demonstrate what a lot of brain training programs promise, but few seem to deliver; genuine cognitive benefits that generalised to additional untrained cognitive domains/abilities, in older adults.

The positive effects seen are quite large, and as such, the results appear to be quite promising. There are still some reasons for scepticism though. Firstly, this result stands in contrast to other research which shows no effect of similar training programs (including another study by Adrian Owen et al., also published in Nature a few years ago). Secondly, the number of subjects in this study is pretty small, with only 15 per group. As Button et al. (2013)  have pointed out recently, small sample sizes can lead to an inflation of the estimates of effect sizes.

There are several other issues with the paper, but they have been most ably covered by others, notably Christian Jarrett on the BPS Research Digest, and Daniel Simons on his own blog, so I encourage interested readers to go and check out those sources rather than repeat them here. It would be wonderful if such a simple intervention could halt or slow cognitive decline in older adults, however (as usual) more work is needed with larger groups of people before we’ll know for sure if that’s the case.

A short video from Nature that explains the study is embedded below:

More eye-wateringly egregious neuromarketing bullshit from Martin Lindstrom

Martin Lindstrom is a branding consultant, marketing author, and (possibly because that wasn’t quite provoking enough of a violently hateful reaction in people) also apparently on a one-man mission to bring neuroscience into disrepute. He’s the genius behind the article in the New York Times in 2011 (‘You love your iPhone. Literally’) which interpreted activity in the insular cortex (one of the most commonly active areas in a very wide variety of tasks and situations) with genuine ‘love’ for iPhones. This was a stunningly disingenuous and simple-minded example of reverse inference and was universally derided by every serious commentator, and many of the more habitually rigour-phobic ones as well.

Unfortunately, it appears his reputation as a massive bull-shitting neuro-hack hasn’t quite crossed over from the neuroscience community into the mainstream, as I realised this weekend when I settled down to watch The Greatest Movie Ever SoldMorgan Spurlock’s documentary about branding, product placement and the general weirdness of the advertising world is generally excellent, however, it unfortunately makes the mistake of wheeling on Lindstrom for a segment on neuromarketing. You can see his piece from the movie in the video below:

Lindstrom conducts a fMRI scan with Spurlock as the subject, and exposes him to a variety of advertisments in the scanner. Fair enough, so far. Then however, Lindstrom explains the results using a big-screen in his office. The results they discuss were apparently in response to a Coke commercial. According to Lindstrom the activation here shows that he was “highly engaged” with the stimulus, and furthermore was so “emotionally engaged” that the amygdala which is responsible for “fear, and the release of dopamine” responded. Lindstrom then has no problem in making a further logical leap and saying “this is addiction”.

Screen Shot 2013-08-11 at 22.01.26

Needless to say, I have a somewhat different interpretation. Even from the shitty low-res screenshot grabbed from the video and inserted above I can tell a few things; primarily that Lindstrom’s pants are most definitely on fire. Firstly (and least interestingly) Lindstrom uses FSL for his fMRI analysis, but is using the crappy default results display. Learning to use FSLView would look much more impressive Martin! Secondly, from the very extensive activity in the occipital lobe (and elsewhere), I’m able to pretty firmly deduce that this experiment was poorly controlled. fMRI experiments rely on the method of subtraction, meaning that you have two close-but-not-identical stimuli, and you subtract brain activity related to one from the other. As in this case, say that you’re interested in the brain response to a Coca-Cola commercial. An appropriate control stimulus might therefore be, say, a Pepsi commercial, or even better, the Coke commercial digitally manipulated to include a Pepsi bottle rather than a Coke one. Then you subtract the ‘Pepsi’ scan from the ‘Coke’ scan, and what you’re left with is brain activity that is uniquely related to Coke. All the low-level elements of the two stimuli (brightness, colour, whatever) are the same, so subtracting one from the other leaves you with zero. If you just show someone the Coke advert and compare it to a resting baseline (i.e. doing nothing, no stimulus) you’ll get massive blobs of activity in the visual cortex and a lot of other places, but these results will be non-specific and not tell you anything about Coke – the occipital lobe will respond to absolutely any visual stimulus.

By the very widespread activity evident in the brain maps above, it appears that this is exactly what Lindstrom has done here – compared the Coke advert to a resting baseline. This means the results are pretty much meaningless. I can even make a good stab at why he did it this way – because if he’d done it properly, he’d have got no results at all from a single subject. fMRI is statistically noisy, and getting reliable results from a single subject is possible, but not easy. Gaming the experiment by comparing active stimuli to nothing is one way of ensuring that you get lots of impressive-looking activation clusters, that you can then use to spin any interpretation you want.

fMRI is a marvellous, transformative technology and is currently changing the way we view ourselves and the world. Mis-use of it by opportunistic, half-educated jokers like Lindstrom impoverishes us all.

Prism Brain Mapping

286-1Prism Brain Mapping is an online assessment package that promises… Well… it promises all kind of things, from “Enhanced selling skills” to “Developing female leaders” to 360 degree assessments”, whatever the hell that’s supposed to mean. It appears to be a pretty big deal, with practitioners all around the world and a certification program for new ‘practitioners’.

So, what is it? It’s basically a re-packaging of some old psychometric tests with a neuroscience-y sounding spin. Or in their words:

“It represents a simple, yet comprehensive, synthesis of research by some of the world’s leading neuroscientists into how the human brain works, and why people, who have similar backgrounds, intelligence, experience, skills, and knowledge, behave in very different ways. The instrument’s graphical representation of the human brain serves, not only to remind people of its biological basis, but also to help demonstrate the equally valuable merits of specific cerebral modes.”

The central idea seems to be to divide the brain up into four colour-coded segments, like so:

brainhemispheres

…and then produce a matching colour-coded report that divides the responses up into several behavioural domains:

prism_report

Quite what those four domains have to do with the colour-coded segments of the brain is never really made clear. Of course, this is just another version of the hoary old left/right brain neuromyth. Needless to say, it also has nothing whatsoever to do with ‘brain mapping’ in any even vaguely-meaningful sense.

Prism also provides an exhaustive 42-page ‘Professional report’ (sample version here) that incorporates all kinds of psychometric-type measures, including emotional intelligence, the ‘Big Five‘ personality traits, and ‘Mental toughness’ as well as their custom (i.e. made-up) colour-coded profiles. The whole site is awash with neurobollocks, particularly their “Science behind Prism” page which basically waffles ‘Because: BRAINS!’ for 1500 words.

I got curious about who was behind this. The ideas behind it are utter drivel, but the implementation is actually fairly sophisticated, and they’ve certainly done their homework on the brain stuff. There are no names at all on the site, and that only made me even more curious; however, one of their promotional leaflets mentions something called the Center for Applied Neuroscience. A quick whois look-up on that domain reveals it was registered by someone called Charles De Garston who (from his LinkedIn profile) is the owner of another business named Team Dynamics International. Also heavily involved in Prism is Lisa De Garston, who runs a Prism-related group on LinkedIn.  Neither of these two seem to have any (higher) academic qualifications at all, let alone any in neuroscience or psychology. The only other name I can identify who’s involved is Andrew Sillitoe, who runs a coaching/leadership/consultancy/pointing-out-the-bleedin’-obvious business called Managing the Mist.

So, a good example of an apparently successful business built on a slippery foundation of the most reekingly odious  effluent. I’m pretty much in awe of their audacity to be honest; they’ve spent a great deal of time researching this stuff and coming up with something that’s just plausible enough for an uninformed audience to swallow, and their implementation is highly professional and very slick. I almost feel like cheering them on, but that doesn’t change the fact that you’d get about as much insight into ‘brain mapping’ from holding an actual glass prism up to your ear than from doing these online psychometric tests.

Prism Brain Mapping was previously the subject of a brief post by NeuroSkeptic, which is (of course) worth a read. Also, many thanks to Amy Brann who brought it to my attention on Twitter.

How to develop and market your neuro-product

Billion_Dollar_Brain_poster

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.

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

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.