A Prescription Video Game Treatment for ADHD?

 By Jonah Queen

Image by Nenad Stojkovic
via Flickr
In June of last year, the FDA approved a unique new treatment for attention-deficit/hyperactivity disorder (ADHD) which attracted significant media attention. But this new treatment is not a medication or a neurostimulation device — it is a video game. The game, called EndeavorRX and developed by Akili Interactive, is the first video game (or, as the FDA press release announcing its approval describes it, a “game-based digital therapeutic device”) that has received FDA approval as a medical treatment.

The game, which can be played on iPhones and iPads, is designed to improve attention in children between the ages of 8 and 12 who are diagnosed with ADHD. According to Akili, it was developed taking neuroscience research into account and is designed to target specific brain regions and neural circuits. Gameplay (which can be seen in the game’s trailer) involves racing down a track while collecting certain items and avoiding others. Presumably, the focus required to complete those tasks helps to train attention. Recommended treatment involves completing a set number of game “missions” a day (around 25 minutes of gameplay), five days a week for two four-week-long periods with a break in between. Akili emphasizes that the game is not intended to be a replacement for medication or therapy and is best used as a supplement to conventional ADHD treatment.

FDA approval was based on five clinical trials of EndeavorRX’s effectiveness (including one that was published in The Lancet Digital Health). According to the studies, the game improved attention in sample groups of children with ADHD when compared to an educational video game (used as a control). Measures of attention were based on Test of Variables of Attention (TOVA) scores and parent self-reporting (through the ADHD Impairment Rating Scale).

Akili has been conducting further research on EndeavorRX. In October, they presented additional data supporting its effectiveness at the American Academy of Child and Adolescent Psychiatry Virtual Annual Meeting. This data indicated that, in addition to improving attention, use of the game also improved the children’s performance on math and reading standardized tests. Another clinical trial was published in Nature in March 2021, and current research is being done on possibly using the game to treat cognitive impairment (“brain fog”) in patients recovering from COVID-19.

The idea of a video game designed to help those with ADHD doesn’t sound too far-fetched. Educational video games have existed for almost as long as video games have. And there are many game-based “brain training” apps available (including those which claim to be backed up by neuroscience research) as well as general health and wellness apps (some of which are also prescription only). Mental health apps, in particular, have recently increased in popularity due to the COIVD-19 pandemic, and EndeavorRX’s approval benefitted from new, less-stringent rules for such low-risk mental health treatments that the FDA implemented in spring of 2020.

But this is the first time a video game has been approved by the FDA as a treatment for a specific condition, allowing it to be prescribed by doctors and marketed as a medicine, just like conventional medications and medical devices.

This intended status as a medicine is made clear on the EndeavorRx and Akili websites. The game is described as a “treatment,” a “therapeutic,” and even a “medicine.” There is also information similar to what one would expect from the website for a conventional medicine: how to obtain a prescription, the pharmacy that dispenses it (Phil pharmacy), the recommended “dosage,” and reported side effects (which include headache, dizziness, nausea, frustration, aggression, and other “emotional reaction[s]”). The game is currently available and being prescribed, though Akili has not yet released statistics on the game’s use.

Image by Martin Vorel via Libreshot
A free demo of the game is available for download on the Apple App Store, with a disclaimer stating that it is for “informational purposes only” and does not provide the “therapeutic” benefits of the full game. I played through the demo to get a better sense of the gameplay. The game is science fiction-themed, and the player controls a character who is sent to different planets to conduct research. Gameplay involves steering a craft down a track by moving the phone (or iPad). The goal is to move through certain zones on the track while also tapping the screen when a certain color of creature appears (and ignoring the other colors). It does require focus, multitasking, and fast reaction times, and adjusts the difficulty in response to the player’s performance.

While much of the response from the media, the public, and healthcare professionals towards EndeavorRX has been positive (J. DiCarlo, personal communication, April 21, 2021), there are those who are skeptical. Several of the news reports about the game note that some of the authors of the studies are either Akili employees or paid consultants for the company, but as other have pointed out, this is common for clinical trials.

Some in the medical field have also questioned the games effectiveness. Several psychologists and psychiatrists who specialize in pediatrics or ADHD have expressed surprise that it received FDA approval and believe that it needs additional study to determine its effectiveness. They specifically mention that the data presented by Akili do not provide a strong enough case that the game has any real-world benefit, since scores on tests like the TOVA do not necessarily indicate there will be improvements in schoolwork, and parent self-reporting can be inaccurate or the result of the placebo effect. Akili’s branding of the game as a medicine has even been called a “marketing ploy.”

There is also some criticism and confusion from the public, as can be seen in comments on the news articles and reviews of the game’s demo (which currently has a 2.9 star rating). Many people are skeptical of the game’s effectiveness, do not understand why the game is prescription only, dislike the graphics and gameplay, are worried about it contributing to video game addiction, or just “don’t get it.”

And while a negative response from anonymous internet reviewers and commenters does not say much about a product’s value, it is not surprising that EndeavorRX is controversial. The idea of an FDA approved video game does sound strange. Video games are primarily used as entertainment, and even when they are intended to be educational or to improve skills they are not referred to as a medicine nor do they require a prescription to play. Medications and medical devices are assigned a prescription only status when they have the potential to be dangerous if misused. But what harm can a video game cause?

Image by verkeorg via Flickr
According to Akili, EndeavorRX is available only with a prescription and was submitted to the FDA approval process so that it can be marketed as treating a specific condition (which it was designed to do, unlike other video games) and so that it can be covered by medical insurance. It is currently not covered by many insurance companies, but Akili is hoping that will change. This adds to the controversy: is a video game, even a medical one, worth the price? Especially when it is priced more like a medicine than a video game (“less than $300 for a 3-month prescription,” according to the EndeavorRX website)?

The lead author of one of the clinical studies (who is also the director of the ADHD Program at the Duke University School of Medicine) argues that much of the criticism directed towards EndeavorRX is due to the novel and “innovative” nature of the treatment. And this may be true to some extent. There are those who might dismiss EndeavorRX simply because they cannot imagine a video game being an effective psychiatric treatment. But the criticism from the medical community has focused mostly on the research and the game’s effectiveness, rather than the form it takes. And it is also possible that a treatment in the form of a videogame could have its own risks, in term of the effect of additional “screen time” on children.

When discussing a new technology, it is important not dismiss it merely because it is new and different and also important not to assume that its novelty automatically makes it better. This is particularly a problem in neuroscience where some warn about the dangers of “neurohype.”

So when it comes to a unique technology like EndeavorRX, we should look beyond the novelty and hype and focus on the same measures that we would for a conventional psychiatric treatment. Fortunately, it seems that both the supporters and skeptics in the medical field are doing just that. And with time and additional research, we will get a better picture of whether this prescription video game lives up to the hype.

Jonah Queen is an editorial intern at AJOB Neuroscience and the senior layout editor for The Neuroethics Blog.

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Queen, J. (2021). A Prescription Video Game Treatment for ADHD? The Neuroethics Blog. Retrieved on , from http://www.theneuroethicsblog.com/2021/07/a-prescription-video-game-treatment-for.html