Akili Interactive Labs on Monday reported that its late-stage study of a video game designed to treat kids with ADHD met its primary goal, a big step in the Boston company’s quest to get approval for what it hopes will be the first prescription video game.

In a study of 348 children between the ages of 8 and 12 diagnosed with ADHD, those who played Akili’s action-packed game on a tablet over four weeks saw statistically significant improvements on metrics of attention and inhibitory control, compared to children who were given a different action-driven video game designed as a placebo. The company plans next year to file for approval with the Food and Drug Administration.

“We are directly targeting the key neurological pathways that control attention and impulsivity,” said Akili CEO Eddie Martucci. The study “was meant to be a strong objective test to ask: Is it the targeting we do in the brain or is it general engagement with a treatment that’s exciting and interesting … that actually leads to these targeted effects? And so I think we clearly see that it’s the targeted algorithms that we have.”

Despite the positive results, questions about the product remain. For instance, parents and physicians subjectively perceived about the same amount of improvement in children’s behavior whether they were playing the placebo game or the therapeutic game. And if Akili can get approval, it remains to be seen whether clinicians and insurers will embrace its product.

The video game has not been tested head-to-head against ADHD medications or psychotherapy to see if it’s equally effective.

Akili’s video game, which is played on a tablet, sends players down a molten lava river and through an icy winter wonderland, rewarding them with stars and points as they complete tasks. Akili sees the video game as the delivery system for targeted algorithms that act as a medical device to activate certain neural networks. That’s a different category than existing apps and games that help patients manage their disease, such as those that deliver cognitive behavioral therapy or help patients track symptoms or monitor their glucose levels.

“We have something that looks and feels and is delivered through a video game,” Martucci said, “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.”

The researchers recommended that kids complete a 30-minute session of the game five days a week for four weeks. Just 11 of the participants reported adverse events, mainly headache and frustration—much milder than the usual side effects associated with the drugs often used to treat ADHD.

Akili is also studying whether a similar version of its video game may have promise in treating adults with depression; the company recently started a mid-stage clinical trial in that population, with early results expected late next year. Akili has also explored the therapy’s potential in early stage studies of patients with pediatric autism and multiple sclerosis.

Akili is pioneering a new class of therapy at a time when the FDA is expanding its view of what can be considered a treatment, opening the doors to all sorts of new products.

In September, the FDA approved the first mobile app to claim clinical benefit in helping patients manage certain substance use disorders, developed by the Boston company Pear Therapeutics.

Then, last month, the FDA approved the first pill that can alert your doctor when you swallow it. It’s a version of the schizophrenia drug sold as Abilify, embedded with sensor, and was developed in collaboration by the Japanese drug maker Otsuka Pharmaceutical and the Silicon Valley company Proteus Digital Health.

Republished with permission from STAT. This article originally appeared on December 1, 2017