FDA Approves First Ever Prescription Video Game

"The new game as a prescription is historical. 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."

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FDA Approves First Ever Prescription Video Game

For the first time, the Food and Drug Administration has approved a prescription video game. Doctors may now prescribe Akili Interactive's EndeavourRx, formerly known as Project EVO, to Children with Attention Deficit Hyperactive Disorder (ADHD) between the ages 8 and 12.

ADHD is one of the most common neurodevelopmental disorders, seen in adults as well; however, more prevalent in children, often following into adulthood. People diagnosed with ADHD have trouble paying attention, controlling impulsive behaviours or even maybe overly active. However, the symptoms of the disorder are not just limited to these challenges.

There is not a single test to diagnose ADHD, as many other problems like anxiety, depression, sleep problems and certain types of learning disabilities have similar symptoms. Diagnosing ADHD usually includes a checklist of rating ADHD symptoms, and taking a history of the child from parents, teachers and sometimes the child.

In Adults, ADHD may be associated with depression, mood or conduct disorders and substance abuse. Adults with ADHD often cope with difficulties at work and in their personal and family lives related to ADHD symptoms. They may experience problems in their day to day lives and may have chronic feelings of frustration, guilt or blame.

A person may not be diagnosed with the disorder until adulthood because teachers or family did not recognize the condition at a younger age. Adults with ADHD can be treated with behavioural interventions, medication or a combination of the two.

In both the cases of adults as well as children, ADHD is best treated with the combination of behaviour therapy and medication. However, in children, behaviour therapy is recommended as the first line of treatment before medication is tried.

However, the new game as a prescription is historical. 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 developers have said that the game stimulates neutral 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. The video game will, however, be used alongside other therapies such as clinician-directed therapy, medication and educational programmes.

"The Endeavour 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 FDA's Centre for Devices and Radiological Health, said in a statement.
The game underwent a total of seven years of clinical trials, including a study of over 600 children to figure out whether a game could actually make a difference with kids suffering from ADHD.

Across five separate researchers examined whether EndeavourRx could affect the ADHD symptoms in children. The most common side effects are frustration and headache which seems mild in contrast to traditional medicines that can have side effects that include sleep problems, decreased appetite, weight loss, and many others.

In one of the studies, one out of three kids "no longer had a measurable attention deficit on at least one measure of objective attention" after playing EndeavourRX for 25 minutes a day five days a week, for a whole month. "Improvements in ADHD impairments following a month of treatment with EndeavourRx were maintained for up to a month," said the company. "We're proud to make history today with FDA's decision," said Eddie Martucci, CEO of Akili, in a press release from the organization.

Dr. Natalie Sergent, a Licensed Psychologist at Primary Children's Center for Counseling, Utah said "Parents should also know EndeavorRx has only proven to treat some kids who have two of the three types of ADHD in studies and trials. This video game, in particular, was developed for the inattentive type and for the combined type, but it has not been shown to have any impact on hyperactivity at all."

Akili has plans to roll out similar platforms for other conditions in its development pipeline — and newer contenders in the DTx video game therapeutic space for ADHD, like Braingaze — which is yet to be FDA cleared —  will have to expand their features in order to appeal to parents who will have already become accustomed to using Akili's platforms for their ADHD-diagnosed children.
While not a completely fool-proof solution to ADHD, EndeavorRX actually brings to attention the development video games have seen over time.

The games have come a long way from being merely distractions or a form of exercise. For EndeavorRX, the next step is to actually launch the game, now that approval is taken care of.

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