?In September 2011 ,the most advanced computer game to use a consumer brain computer interface (BCI) will go on sale. Its name is Focus Pocus (see video trailer here, its awesome) and it is aimed at children with ADHD so that they might use gamification to train their brains to improve focus and impulse control.
Use your brain to battle an evil necromancer!
The game is based on neurofeedback enabled by the use of the Neurosky dry-electrode EEG (Electro-EncephaloGram) headset, which anyone can purchase for under $100 (or 100 Euros if in Europe)? Earlier this week, BBC2 did a special on the headset. The basic Idea is that the single electrode on the Neurosky headset (placed on the forehead) is able to pick up a few simple and characteristic brainwaves (created by activity in populations of neurons), some that have been shown to be enriched when the subject is awake and attentive (ex. Beta-waves), and some when the subject is relaxed (ex. alpha waves). Neurosky has developed algorithms to funnel these and other brain waves into measures of ?focus? and ?meditation.? Look here for more details on how it works.
Neurosky Mindwave Headset from neurosky.com
In the game, the player needs to attain a certain level of focus or meditation to zap monsters, to change one object to another in transformation class, to levitate, to ride a broomstick, or to win a duel with an evil necromancer (a bit reminiscent of Harry Potter). The idea is that through these different activities, the players would be exercising mental capacities that would generalize outside the game (into the classroom, for example). Developed by Roll7? in partnership with Neurocog and the University of Wollengong,??Focus Pocus will be marketed as an alternative to medication or as an adjunct therapy for children with ADHD. The game will be available also to the general population for fun and focus-enhancement.
I, for one, can?t wait for this game to come out.
Curiosity peaked, I purchased a couple of these Neurosky Mindwave headsets last week and brought them to a class of students (as we were studying the basic principles of BCIs)?to see what it was like to play videogames controlled with brain-waves. With the computer hooked up to a projector, students came one-by-one to play a few of the simpler, free games that come with the headset; the class laughed and applauded successes and gave each other tips on how to reach the highest levels of ?focus?. Among strategies used were, 1. Stare at a small detain in the computer screen, 2. Recite poetry or sing a song in your head, 3. Imagine your way home from school in great detail.?It seemed that the focus?was affected?by things other than focus on the game itself.?Once, to great laughter, a student put on the headset and had no signal at all! ?Oh no, I have no brain!? she said. But then we realized the electrode did not have good contact with her head and her focus levels went up. We also used the headsets to monitor attention levels as we watched a few student-made short films. At the end of the day, the class unanimously declared the technology ?really really fun.?
Brain Athlete helps you get your mind into the game
Myndplay, a software developer for the neurosky platform, has made an archery game in which you get highest scores when your brain-waves resemble those of Olympic archers when they get bulls-eyes (see bbc2 video above for a demonstration). And another company has developed the Brain Athlete visorto help amateur golfers get into the brain state associated with good shots. Neurosky even hold the Guinness world record for the heaviest machine moved by a BCI.
Ok, you might be saying, this technology is really cool (and it is), but where is the ethical issue? This is a practical ethics blog, after all.
One ethical issue is grounded in the reverse inference problem (the idea that a certain behavior might be associated with an enrichment of particular brainwaves but an enrichment of those particular brainwaves might not be causally linked with that behavior). Gamers may train their brain-waves to look like Olympic Archers, for example, but get no better (or get worse) at actual archery. Kids may train their brain-waves to high levels of the game?s focus, but only get better at daydreaming (as might be suggested by the observation that practicing singing songs etc spikes the focus reading). Now, the reverse inference problem is not a problem at all if we are just playing video-games or playing with toys. The problem becomes a problem when we are playing the games in order to do something else, like improve our archery skills, golf game, meditation skills, performance in the classroom, or are using the information to determine which parts of films to keep or cut. These reverse inferences (which are claims about efficacy) require specific testing, preferably in randomized, double-blind, placebo and sham-training controlled trials. The consequences of unsubstantiated claims might be less in some cases (amount to false advertising in some consumer cases) than others (therapeutic misconception and/or harm due to missed opportunity or complication with other treatment in the medical application cases).
Admirably, neurocog, one of the partners developing Focus Pocus has a declared commitment to research:
?Our?mission?is to design and produce software solutions for training cognitive processes and brain electrical activity, and to conduct research in this area.?
And the games used in Focus Pocus are based on software that made significant improvements in kids with ADHD in a published pilot study?(see a newspaper account here). But this study had a small sample size (as it was a pilot) and needs to be corroborated by further research. Though the use of neurofeedback for treatment of ADHD has other support like in the literature, its safety and efficacy is still hotly debated (see http://www.tandfonline.com/doi/abs/10.1080/10874208.2010.523340, http://www.ncbi.nlm.nih.gov/pubmed/21561933, http://www.ncbi.nlm.nih.gov/pubmed/19207632 ).
Mind Flex
Other products have not even been even this diligent. Mattel?s Mindflex, for example, links players floating a ball to high levels of theta-waves, which it calls ?focus?. There is good evidence, however, that kids with ADHD already have theta levels that are much higher than controls and many hypothesize this enrichment to be mechanistically related to the disorder (reviewed here), which raises the question of?whether playing MindFlex could actually?exacerbate ADHD symptoms ? Fortunately, those at neurocog are familiar with this research on theta waves and ADHD as some of it was done by their academic collaborators. Not to mention that training specifically to increase theta waves has been reportedly associated with increased risk of seizure, resurgence of traumatic memories, and even depression (though it is worth noting that other toys, such as bicycles and pogo sticks also have risks).
A further complication is based on specificity (the idea that modulating certain brainwaves might also modulate off-target brain activity). There is some evidence that at least one of the wave-forms (theta) that games might help minimize may be helpful for other activities, such as musical performance.
Efficacy and safety concerns are typically subject to some sort of regulatory body. EEG biofeedback devices are regulated in the USA by the FDA (food and drug administration) as class II medical devices and approved to be marketed for intended use only for relaxation and muscle reeducation. Moreover, they can count as non-prescription class II devices only if their intended use is relaxation, otherwise they are considered prescription devices (i.e. not given to the general population; see http://www.aapb.org/edu_labeling_approval.html).
So should BCI games be regulated by the FDA? ?Though it is not clear-cut, it seems that if their intended use if for the treatment of a medical condition, they should; and that if the intended use is not relaxation (i.e. if it is rather the treatment of ADHD or delay of Alzheimer?s), then safety and efficacy data should be presented to the FDA. It is worth noting that it is currently illegal to claim efficacy in treating an illness without providing such information see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080198.htm) ?(similar to the way nutritional supplements must make a disclaimer ?This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.? ). Use for enhancement hazier; while one could argue that efficacy should be shown it seems like certain safety standards at least should be met.
Neurosky indicates on its website that it is primarily a tech company and that:
Our current offerings are not FDA certified as it would add time and cost to an equation that does not tolerate either well. We do not, ourselves, design medical equipment, it is not our goal. Having said that we do work with numerous developers that are, in fact, developing for the medical community. These projects range from treatment for ADHD to diagnostic/treatment systems for cognitive disorders. To support our partners in the medical community we furnish components manufactured to the ISO 13485 spec. This allows our partner to design their medical solution in a way that it is ready for them to bring it through the FDA and other medical certifications.?
It is certainly true that FDA certification and monitoring add time, cost, and may stifle innovation. But isn?t it true that these games still use the same biofeedback technology that the FDA considers worthy of the class II medical device label? Efficacy might no-longer be an issue, but safety should. But should regulation of the BCI toys and games is better addressed by consumer safety (or perhaps like video games) than by the FDA?
As the realms of medical and consumer technology blur and as the uses of such BCIs mushroom (Neurosky?encourages open innovation by?offering free development software to help anyone with the time and skill to develop new games for the system) these questions merit further consideration.
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