A video game designed to treat kids with attention-deficit/hyperactivity disorder (ADHD) is one step closer to winning approval from the Food and Drug Administration, according to the Boston firm that created it, Akili Interactive Labs. The company says the tablet-based game was successful in a late-stage clinical trial and plans to file for regulatory approval next year, STAT News reports.
Akili claims that with its technology, “Treatment looks and feels like a high-end interactive action video game.” The game is based on research done at the University of California, San Francisco, and it'sdesigned to measure how the brain responds to multi-tasking in a challenging (virtual) environment while trying to meet certain goals. One version has patients tilting a tablet to steer the character's hoverboard, dodging fiery potholes and looking for special orbs along the way.
How does playing a video game help with ADHD? Onscreen stimuli is meant to excite certain parts of the brain; in the case of its ADHD software, called AKL-T01, that means getting neurons to fire in the front of the brain, in areas devoted to attention, impulse behavior, and cognitive control. The game can also adapt, responding to reaction time and other data from the user.
Akili prefers to think of itself as a medical device company, and uses medical terminology to talk about its products, substituting phrases such as “prescription digital medicine” for “video game” and “dose” for “round of play.” But as for how and why its treatments actually work, the company isn’t totally sure. In a recent interview, Akili CEO Eddie Martucci makes the comparison to ADHD drugs that affect brain chemicals, saying the right software can more directly stimulate those neurons which could help some people. “But exactly how that happens,” he said, “I would honestly say that’s still something we—and the world of neurology—are still figuring out.”
As part of that process, Akili has been testing the game with patients. For its recent trial, the company worked with 348 children ages 8 to 12 who’d been diagnosed with ADHD and randomly assigned them to play either the Akili game or a similar game not designed to be therapeutic. They were told to play a video game for 30 minutes a day, five days a week, over four weeks. (Comparing two video games was meant to separate out any effects particular to AKL-T01 versus those resulting from gaming more generally.)
The treatment group saw significant improvement in sustained attention and inhibitory control, according to Akili. It hasn’t yet released the full results of the study, saying that a full analysis is underway and the results will be presented at a conference and published in a peer-reviewed journal next year. The game hasn’t yet been compared to therapy or medications for ADHD, but still the company said it plans to submit the game for FDA approval.
The company is optimistic, but some questions remain. Right now the public only has a small sliver of Akili’s data; the picture may change after a peer review. And while the data shows significant improvements among patients, physicians and parents subjectively reported about the same improvement whether participants had played the therapeutic game or the placebo. There have been few reported side effects so far, with some players complaining of headaches and frustration, but that’s mild compared to today’s typical ADHD medications. (Pharmaceutical companies Merck and Amgen invested in Akili last year and the company is conducting clinical trials for another version of the game for adults with depression.)
Still, even if the ADHD game gains FDA approval, there’s no guarantee that clinicians will embrace Akili’s vision of “digital medicine.” It’s a novel category—the FDA approved the first digital pill last month—and one whose potential is just beginning to be explored. “We have something that looks and feels and is delivered through a video game,” Martucci told STAT, “but when someone’s using it, they’re getting a direct physiological activation that will lead hopefully—and we have a nice glimpse of data now—to cognitive and general clinical improvement.” If so, Akili might have something truly remarkable on its hands.
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