First Video Game for ADHD Approved by US FDA
Sat, January 28, 2023

First Video Game for ADHD Approved by US FDA



In most cases, video games are linked to the risk of gaming disorder. But these games have potential benefits in select scenarios. Recently, a US federal agency approved a video game to be marketed as a therapy for a brain disorder.

The marketing of a video game as therapy for attention deficit hyperactivity disorder (ADHD) was approved by the US Food and Drug Administration (FDA). It is the first video game to be considered as a potential treatment for the disorder. However, the agency only approved the game as an indication for children aged eight to 12 years, who are diagnosed with primarily inattentive or combined-type ADHD. The game has been determined to increase the attention function of patients.


Known Facts on ADHD

Unfamiliar to most people, ADHD is a neurodevelopmental disorder of childhood. According to the US Centers for Disease Control and Prevention (CDC), a federal agency, a person with ADHD is usually diagnosed during their childhood. If the disorder persists, the symptoms are expected to last until adulthood. The hallmark symptoms of ADHD include trouble paying attention, difficulty controlling impulsive behaviors, and being excessively active.

However, there are other symptoms that may be developed, such as excessive daydreaming, frequent forgetfulness, extreme talkativeness, carelessness, and the inability to get along with others. From these symptoms, a specialist classifies what kind of ADHD type a person has. So far, the three main types are predominantly inattentive presentation, predominantly hyperactive-impulsive presentation, and combined presentation.

The predominantly inattentive presentation is characterized by the dominance of attention issues. A person with this presentation can be observed as unable to organize or finish a task, pay attention to details, or even follow conservations or instructions. As a consequence, they often forget the details of whatever happened during the day.

The predominantly hyperactive-impulsive presentation is characterized by the other set of issues, mainly, difficulty in controlling impulsive behaviors. A person with this presentation mostly experiences restlessness, lots of fidgeting, and tactless interruption of others. In other words, the individual lacks the patience to wait for their turn.



Finally, combined presentation is characterized by the equal presence of both sets of issues. Regardless of type, a person with ADHD is prone to accidents and injuries. They are also susceptible to other health conditions because of excessive behaviors. For instance, an ADHD patient who excessively eats sugar can be at risk of diabetes.



New Digital-Based Therapy Approved for ADHD

On June 15, 2020, the FDA approved the marketing of a video game title as therapy for pediatric ADHD. The agency permitted the marketing after verifying the game's potential in improving the attention function of patients. The game has been called EndeavorRx and is the first game-based digital device to be approved for the disorder. But it could only be obtained by ADHD patients through a prescription.

"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. The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics," said Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health at FDA.

Based on the data from the CDC, more than 7 million US children and teenagers had ADHD in 2016. About 388,000 children aged two to five years, 4 million children aged six to 11 years, and 3 million children aged 12 to 17 years suffered from the disorder. Statista, a German portal for statistics, showed that the majority of children with ADHD in the country are boys. In 2018, 13% of children diagnosed with the disorder were boys, compared to the 6.6% who were girls.



The decision to approve the video game was derived from the data of multiple studies, which involved over 600 children. Those studies explored various aspects of video game use to treat ADHD. One of the key aspects examined was the boost in attention function. One study published in the journal Lancet showed the therapy's performance in pediatric ADHD.

A total of 348 children aged eight to 12 years were randomly assigned to play either the therapeutic video game or another video game. One hundred eighty children were assigned to the therapeutic game while 168 were assigned to the control game. Researchers who conducted the trial investigated the improvements in cognitive control and target attention. Participants played their respective games for 25 minutes per day for five days each week, within four weeks.

Results showed that no serious side effects were reported. No discontinuations were reported as well. The most common adverse events from playing the games were frustration in 3% of subjects and headache for 2% of subjects. Akili Interactive, the developer of the video game, revealed that one-third of the subjects no longer had measurable attention deficit in at least one measure. About half of the parents observed clinical positive change in the everyday attention function of their child a month after the treatment. The positive change could be up to 68% higher if a second treatment was given to the child. Overall, the duration of the improved attention function could last for one month after therapy of four weeks.



The general intent of the video game is to challenge the cognitive skills of the patient. The challenge maintains the patient's interest without ruining entertainment, which explains the minimal frustration events. As the game motivates the mind, the patient unknowingly improves their cognitive function. Through sensory stimuli, the patient's neutral systems are engaged to prevent boredom, hone cognitive skills, and provide entertainment for several minutes.

At the moment, the video game is only designed for pediatric ADHD patients aged eight to 12 years. The indication prescribes the game for those with predominantly inattentive presentation and combined presentation. The therapeutic benefits do not work on cases of predominantly hyperactive-impulsive presentation. Although some parents may be concerned about their kids getting addicted to video games, other parents who are worried about pharmacological treatments may see the novel therapy as an alternative.