The U.S. Food and Drug Administration (FDA) has for the first time approved a video game for treating attention deficit hyperactivity disorder (ADHD) in children.
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, called EndeavorRX formerly Project EVO, might not look like much of a video game, but may go down in history.
The game challenges users to dodge obstacles and collect targets as they navigate icy winter wonderlands and lava rivers, guided by aliens who zip around on flying saucers.
The developer says the game stimulates neural systems that are intrinsic to attention function.
It also features adaptive algorithms that monitor each patient’s progress as they play, allowing for personalized ADHD treatment.
FDA now authorizes doctors to prescribe the iPhone and iPad game for kids between ages 8 and 12 years old who struggle with ADHD, after it underwent seven years of clinical trials that studied over 600 children to figure out whether a game could actually make a difference.
In one particular study, one-third of kids treated no longer had a measurable attention deficit on at least one measure of objective attention after playing the obstacle-dodging, target-collecting game for 25 minutes a day, five days a week for four weeks.
Half of the parents also said they saw a meaningful change in their child’s day-to-day impairments.
Although the study’s findings bode well for the effectiveness of EndeavorRx, it is important to note that it was conducted by doctors who work for Akili Interactive, the game’s developer.
The researchers also wrote in the conclusion that their results should not be read as a suggestion that EndeavorRx be used as a substitute for established ADHD treatments.
The FDA recommends that doctors prescribe game as a supplement to other treatments, such as therapy and medication.
ADHD is a common neurodevelopmental disorder which is usually first diagnosed in children and can last into adulthood.
Approximately 4 million children aged six to 11 are affected by ADHD, the symptoms of which include difficulty staying focused and paying attention and difficulty controlling behavior.
“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” Dr. Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a press release.
The agency noted that some negative effects were reported, such as frustration, headache, dizziness, emotional reaction and aggression, but said there were no “serious” adverse effects reported.
Akili says EndeavorRx will be made available to families soon.
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