The U.S. company developing the treatment, unlisted Akili, now plans to file for regulatory approval with the U.S. Food and Drug Administration in the first half of 2018.
Playing tailor-made video games can help children with attention deficit hyperactivity disorder (ADHD), according to results from a pivotal clinical trial announced on Monday.
Experts say it will paving the way for what would be the first such ‘digital’ prescription product. Akili is an affiliate of London-listed PureTech Health.
This is a grab from the video game, which helped children with ADHD to improve in a trial. Cases of ADHD have been rising around the world in recent decades, with children often given drugs to treat the disorder.
Akili’s product takes a different approach by using a game to stimulate specific cognitive neural systems in the brain.
In the randomized, controlled trial of 348 children and adolescents with ADHD, Akili’s product AKL-T01 showed a statistically significant improvement compared with an active control in attention performance.
The control was also a video game.
Medicating ADHD is big business, with Shire a leading player in the field. Shire is also an investor in Akili. According to the CDC, three in four young kids diagnosed with attention deficit hyperactivity disorder are put on medicines.
That has continued even after research found behavior therapy is as effective and doesn’t give children stomach aches, sleep problems or other drug side effects. Health insurance coverage for behavior therapy may vary from state to state and company to company.
And in some areas, therapists are in short supply, some experts said.
Last year, CDC officials doubled down on its previous recommendations, calling on doctors and families to try behavior therapy first. ADHD makes it hard for kids to pay attention and control impulsive behavior. More than six million US children have been diagnosed with it.
There’s no blood test for ADHD. Diagnosis is a matter of expert opinion. Studies have shown medications like ritalin help older children with ADHD.
That success has fed a trend to treat younger kids the same way, but there’s been less study of how effective and safe the drugs are for preschoolers.
In behavior therapy, a therapist trains parents – commonly over eight or more sessions – how to guide a child’s behavior through praise, communication, routine and consistent discipline.
However, it can take longer and demand more of parents.