FDA approves video game created by Boston company for treating ADHD in kids

BOSTON — They’ve taken the blame for inciting violence, contributing to childhood obesity, even triggering seizures.

How unlikely, then, that the Food and Drug Administration has just approved a video game as therapy for a symptom of Attention Deficit Hyperactivity Disorder (ADHD) in children.

The FDA said Monday the game built by Boston-based Akili Interactive Labs can improve attention function.

The game, called EndeavorRx, requires a prescription and is designed for children ages 8 to 12 with certain symptoms of ADHD.

“Our technology is based on targeting certain cognitive networks, certain brain functions,” said Akili CEO Eddie Martucci, PhD. “And in this case, our first product platform is based on attention. So It’s people’s ability to pay attention... to resist distraction... to be able to operate normally in daily life.”

The game does not treat the ‘hyperactive’ symptoms associated with the disorder, according to Martucci.

“It’s obviously a first because of what it’s targeting for patients,” said Martucci. “And of course it’s a first by how it looks, feels and is used -- a game on your phone or tablet instead of a pill.”

It's the first time the FDA has cleared a digital therapy for improving ADHD symptoms, and the first time the agency has ever authorized marketing of a game-based therapy for any condition.

The game will be available, initially, for use on iPhones and iPads, but Martucci said expansion to non-Apple devices is planned.

On a superficial level, Endeavor Rx resembles other video games. The fundamental difference is that it's scientifically designed to activate the frontal cortex of the brain, which controls the ability to pay attention. It's also designed so that kids don't know that.

"It's not teaching the child anything explicitly. They're just playing the game. They're just having fun," Martucci said.

However, the game does detect which functional areas of the brain are weak and then challenges users with more difficult tasks.

"If you take the physical fitness analogy, you would never get benefit if you walked into the gym and did the one thing that was really easy for you that you liked doing," Martucci said. "You gotta challenge a little bit. And so the gaming environment automatically displays the environment where you're struggling. And then over time improves that."

"I think it's a treatment that's probably going to be best served as an adjunct treatment to existing treatments or for cases where they're more mild or attentional based," said Timothy Wilens, MD, Chief of Massachusetts General Hospital's Division of Child and Adolescent Psychology. "You know every extra treatment that we have adds to the armamentarium of what we have available for a very common disorder I think is a real benefit to the field."

One government survey from 2016 puts the proportion of American children with ADHD at just under 10 percent.

Many ADHD patients are treated with stimulant medications, such as amphetamine salts and methylphenidate. It is not known precisely how those medications work to improve focus. But one theory is that they effectively increase the concentration of the neurotransmitters dopamine and norepinephrine in relevant parts of the brain.

Wilens said kids with ADHD can get by without treatment -- but it's not easy. One way to picture what they go through is for someone near- or far-sighted to go without glasses.

"So I can take my glasses off. I can function but it's going to be a lot harder for me to see the screen to navigate. And when you think about attention... it's really fundamental to life."

Some children with ADHD who go untreated may have parents resistant to pharmacological intervention, Wilens said. EndeavorRx could be a viable option for them. "There's really limited things they can do for their kids, so it's nice to have options for them."

A therapeutic course of EndeavorRx is five days a week for 25 minutes a day, Martucci said. And he does expect it will be covered by insurance, as with any approved therapy.

As for side effects, Martucci said about 10 percent of patients have reported non-serious issues such as headaches and feelings of frustration. He said the game should be available for distribution soon.

The FDA says it looked at data from multiple studies in more than 600 children. A video of the game shows a character traveling a racecourse-like path in a hover board. Sensory and motor tasks are designed to help the player improve cognitive functioning.

“We’re proud to make history today with FDA’s decision,” Akili CEO Eddie Martucci said in a statement. “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."

Related stories:

Therapeutic video games help boost, regulate kids’ emotional coping skills

New ADHD treatment could involve video games

The Associated Press contributed to this report

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