The First FDA-Approved Video Game Therapeutic

5 min readNov 7, 2020

The brain has always fascinated me and will continue to do so. In my undergraduate studies, I took every course about the brain I could find. Now as I near the completion of my graduate degree in neuroscience, it is exciting to see new types of therapeutics and solutions. While with many other disorders or diseases, the baseline cause is clear, it is not with the brain. It requires researchers to find creative ways to approach these problems.

Combining therapy and newer technology has lead to FDA-approved medical devices. A company interested in treating ADHD opted or a different route, instead aiming to develop a prescription video game. The costs, time and effort required to conduct a clinical trial for an intervention like this are high. There is also the chance that the company spends millions of dollars developing and testing a product only to find it does not work. However, in this case the risks paid off.

Affecting over 6 million children in the USA, attention deficit hyperactivity disorder (ADHD) makes focusing or impulse-control challenging. Children with ADHD are also prone to behavioural problems and anxiety, making learning difficult in the classroom. ADHD makes them more prone to distractions and worse at regulating their emotions. They also have trouble making friends or social interactions in school. These deficits persist into adulthood, culminating in a negative impact on their quality of life. Although 3 in 4 children will receive medication and/or behavioural therapy, more strategies are needed to improve these symptoms.

Akili Interactive Labs looks to add another valuable tool to this arsenal, video games.

While many brain-training video games make plenty of claims, they do not seek FDA approval. A boom of brain-training apps promised to help us age gracefully, but they did not stand up to scrutiny. Apps like Headspace may claim to improve mood, but since they do not make any specific claims towards disease, they are not regulated. Akili Interactive Labs is unique as they looked towards validating their game. This is a necessary step that video game therapeutics need to cement their legitimacy.

This market-opportunity birthed EndeavorRx, a video game that trains children to focus their attention on different tasks and avoid distractions. After several years of clinical trials, they have shown the efficacy of this video game. Prescribed to children between 8 and 12 years of age, Endeavor Rx is a video game played on an iPad or iPhone. By the looks of it, it is a lot more engaging than your standard educational video games.

EndeavorRx gameplay courtesy of Akili

In their clinical trials, children would either receive a placebo video game or EndeavorRx, without knowing which group they were assigned. They tested their video game on 600 children across five different clinical trials, publishing their final results in the Lancet Digital Health journal. Researchers measured this with an objective assessment called the Test of Variables of Attention (TOVA) Attention Performance Index (API).

After playing this game for 25 minutes, 5 days a week for 4 weeks about a third of the children showed dramatic improvements in TOVA-API. Within a month, their score no longer indicated impairment in attention. Additionally, 68% of parents reported seeing meaningful changes in their children’s behaviors after two months of playing this video game.

Though it’s unclear how these results will translate to the real world, the psychological attention test is meant to mimic a classroom setting. This means that the video game shows potential to treat the attention aspect of ADHD when combined with other therapies. It is also unclear how insurance providers will deal with these new costs. The price-tag and need for an iPhone or iPad may prevent many lower-income children from accessing this resource.

The CEO of Akili, Eddie Martucci expressed his excitement for the product in a recent PR release:

With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment. Families are looking for new ways to help their children with ADHD. With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues.

What does this mean for the future of childhood cognitive disorders? It is quite possible that video games targeting specific issues of attention, impulsiveness or cognition will gain traction. Nonetheless, it is quite costly and difficult to conduct clinical trials and prove efficacy. Even when these video games do work in a study, it is sometimes unclear whether this translates into meaningful changes in a classroom setting. Additionally we do not know if this effect on attention is transient or long-lasting. If it does work, we stand to improve our understanding of the mechanisms behind ADHD.

Akili Interactive Labs has raised over $140 million thus far. While the strategy of focusing on obtaining FDA-approval is costly, it puts their product in the hallowed company of other medical devices. The risk, however, is that a product might fail these clinical trials. We are not entirely sure how to design a product that will meaningfully improve symptoms.

Nonetheless, new investors and venture capital firms might be more likely to take a chance on the next digital therapeutic. There is now more evidence to be cautiously optimistic about these digital therapeutics. After all, now that there is evidence the FDA route can successfully create an exciting and useful product. The digital therapeutics market is set to grow to 0.89 billion by 2026, setting the stage for new players to enter the space.

Plenty of studies show positive cognitive impacts of playing video games. Once considered a violence-inducing pariah in society, video games might actually improve attention in ADHD. With increased access to cellphones, computers and tablets, rigorously tested video-game therapeutics could make a huge splash in the coming decade.

The First FDA-Approved Video Game Therapeutic

Written by omiafrin27