Last month, according to an article in the Washington Post, the FDA allowed marketing of a video game as potentially beneficial to children who have been diagnosed with attention-deficit hyperactivity disorder (ADHD).
The game is called EndeavorRx. It was developed for children ages 8 to 12 for use on iPads and iPhones. The children move an avatar across an icy river and along molten lava. During the journey, the avatar is trying to catch flying objects while dodging icebergs and fires.
The developer, Akili Interactive Labs, is now permitted to advertise the game and also approach insurance companies regarding coverage. The game is not yet available for purchase.
And the Critics Say . . .
Akili calls EndeavorRx the future of medicine. However, critics claim that it is a marketing ploy and that money would be better spent on tutoring and other forms of educational activities.
The risks and benefits of “brain-training” via computer have been debated for years. Yet protections are that the industry will be worth about eight billion dollars by the year 2021.
One critic is Russell Barkley, a psychologist who has authored books on ADHD. He reasons that with repetition you just get better at the game or better at other activities that are similar to that game, as opposed to having broader ranging benefits.
The Post also heard from three ADHD experts who, after reviewing Akili’s research, suggested that it was overpromising.
They brought up the fact that these children often had neurodevelopmental disorders. They questioned whether a game could truly provide help for symptoms that included forgetfulness, impulsivity, and distraction. They were doubtful that the program could have an effect on the children’s behavior or schoolwork.
Mark Rapport heads the Children’s Learning Clinic at Central Florida University. He has researched and written extensively about programs similar to EndeavorRx. In his view, the brain-training game is not of “real-world importance.”
And in Response . . .
Akili’s CEO Eddie Marrucci sent out an email expressing the company’s desire to have FDA approval in order for doctors and parents to have confidence in EndeavorRx.
He reacted to various criticisms as misunderstanding the FDA process. Marrucci wrote that the FDA’s approval is evidence that EndeavorRx represents a targeted treatment to cognitive issues.
And in Dispute . . .
The dispute surrounding EndeavorRx amounts to the real-world value of what is actually being targeted.
The strongest evidence for the game’s potential lies in a test called TOVA or Test of Variables of Attention. The test is 21.6 minutes long and asks the children to push a button every time they see a certain geometric shape.
Results of the Study
Results of Akili’s lead study were published last in this year’s February edition of The Lancet journal. According to TOVA’s algorithms, thirty-six percent of the children who played EndeavorRx for twenty-five minutes five days each week, for one month, no longer had an attention deficit according to TOVA.
EndeavorRX was FDA approved under the category Class II medical device. Class II includes certain pregnancy kits and powered wheelchairs. This review process does not have the same restrictions that are required for new medications.
How EndeavorRx Came Into Being
EndeavorRx was invented by Adam Gazzaley, who is a neuroscientist at UCSF and currently an Akili board member.
As of 2013, five studies were conducted involving over six hundred children. Most of these studies were funded in whole or in part by Akili.
Children who were taking ADHD medication or had other psychiatric problems were excluded from the studies. That opens the question of whether the TOVA results would be applicable to these children.
The researchers were careful to point out that the results of the study were insufficient with respect to proven therapies for ADHD. There appeared to be no difference in parents’ assessment of their children who took the EndeavorRx test versus the control group.
Improvements in both groups led the researchers to opine that any type of intervention requiring the child to take part in a structured setting that includes repetitiveness, could be viewed as a possible ADHD intervention.
About Adverse Effects
The Lancet study found no severe adverse effects. However, approximately seven percent of the children participating in the trial had mild to moderate problems such as headaches, frustration, nausea, dizziness, and aggression.
Well over half of the children diagnosed with ADHD take some type of medication. However, many of these medications come with side effects, some quite severe.
Other options are various computer games, fidget-spinners, exercise regimes, clinical trials, or nutritional supplements. One mother took her son for blood tests checking for mineral deficiencies.
The approval of EndeavorRx has opened the door to other game developers who now need only to prove substantial “equivalence” to EndeavorRx.