Akili Interactive Labs has been working on a video game
designed to treat children with ADHD.
348 children diagnosed with ADHD participated in a study
that involved played the game for a period of four
The researchers noticed a significant improvement in the
children's attention and inhibitory control.
- Akili plans to request approval from the FDA next year.
Akili Interactive Labs reported on Monday that its last stage
study of a video game designed to treat children with ADHD met
main objective, a big step in the search for the Boston company to obtain
approval of what you expect will be the first prescription
In a study of 348 children between the ages of 8 and 12 diagnosed
with ADHD, those who played Akili's action-packed game in a
tablet for four weeks saw statistically significant improvements
in metrics of attention and inhibitory control, compared to
children who were given a different action videogame
designed as a placebo. The company plans to present next year
for approval with the Food and Drug Administration.
"We are focusing directly on the key neurological pathways that
control attention and impulsivity, "said Akili CEO Eddie
Martucci. The study "was meant to be a strong objective test for
Ask: Is the goal we do in the brain or is it general?
commitment to a treatment that is exciting and interesting …
which actually leads to these specific effects? And then I think that
see clearly what are the specific algorithms we have. "
Despite the positive results, questions about the product remain.
For example, parents and doctors perceive the same
amount of improvement in the behavior of children, whether they were
playing the game of placebo or the therapeutic game. And if Akili
can get approval, it remains to be seen if the doctors and
insurers will embrace your product.
The video game has not been tested face-to-face against ADHD
medications or psychotherapy to see if it is equally effective.
Akili's video game, which is played on a tablet, sends players
by a river of molten lava and through a wonderland of icy winter,
rewarding them with stars and points as they complete tasks.
Akili sees the video game as the delivery system for the purpose
algorithms that act as a medical device to activate certain
Neural networks That is a different category than the existing applications
and games that help patients manage their illness, like those
who deliver cognitive behavioral therapy or help patients track
symptoms or control your glucose levels.
"We have something that is seen and felt and delivered through
a video game, "said Martucci," but when someone is using it,
are receiving a direct physiological activation that will lead
hopefully, and now we have a good view of the data, cognitively
and a general clinical improvement. "
The researchers recommended that children complete a 30-minute treatment
Game session five days a week for four weeks. Only 11
of the participants reported adverse events, mainly headache and
frustration – much milder than the usual side effects associated
with the medications that are often used to treat ADHD.
Akili is also studying whether a similar version of his video
the game may be promising in the treatment of adults with depression; he
The company recently started a mid-stage clinical trial in that
population, with the first results expected at the end of next year. Akili has
He also explored the potential of therapy in the first stage studies of
patients with pediatric autism and multiple sclerosis.
Akili is a pioneer in a new class of therapy at a time when the FDA
is expanding your vision of what can be considered a treatment,
opening the doors to all kinds of new products.
In September, the FDA approved the
first mobile application to claim clinical benefits to help
patients manage certain substance use disorders, developed by
Boston Pear Therapeutics Company.
Then, last month, the FDA approved the first
pill that can alert your doctor when you swallow it.
It's a version of the schizophrenia drug that is sold as Abilify,
integrated with sensor, and was developed collaboratively
by the Japanese drug manufacturer Otsuka Pharmaceutical and the
Silicon Valley Proteus Digital Health Company.
Read the original article in STAT. Copyright 2017. Follow STAT on Twitter .