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FDA Clears Video Game ADHD Therapy

Brain cell networks

(Gerd Altmann, Pixabay)

16 June 2020. A video game designed to help children improve their inattention and other symptoms of ADHD received authorization from the U.S. Food and Drug Administration. The game known as EndeavorRx, developed by Boston-based Akili Interactive Labs Inc., is being made available by prescription for children age 8 to 12 with ADHD, short for attention deficit hyperactivity disorder.

ADHD is a condition in children marked by difficulty paying attention, staying focused, controlling behavior, and high levels of activity. According to Centers for Disease Control and Prevention, ADHD affects some 4 million children in the U.S. age 6 to 11. Current treatments for ADHD include medication and behavioral therapies, which are limited by undesired side effects from medications, and a shortage of trained therapists, as well as varying insurance coverage for therapies.

Akili developed EndeavorRx as an alternative ADHD treatment that it says delivers sensory and motor stimuli to the prefrontal cortex, the part of the brain dealing with personality expression, decision making, and moderating social behavior. The prefrontal cortex also affects attention and other cognitive functions, such as memory. The company says the game is designed to give children with ADHD a fun experience while stimulating and exercising these brain centers to improve multitasking, focusing on goals, and avoiding distractions. The games are guided by algorithms that personalize the treatments to patients’ specific conditions.

FDA’s clearance is based in part on clinical trial results, including a study published in February in The Lancet Digital Health. In that study, 384 children age 8 to 12 were randomly assigned to receive either EndeavorRx, code-named AKL-T01 at the time, or a digital word game, with both games delivered on tablet devices as part of a therapy program. Participants played their games at home for about 25 minutes per day, five days a week, for four weeks.

The study team found participants using EndeavorRx score higher on a standard, computer-based Test of Variables of Attention index than word game users after four weeks, with no serious adverse effects or discontinuations. On a separate exit questionnaire, more parents of children using the video game report improvements in their children’s attention than parents of children using the word game. Akili also offers a guide for parents, in the form of a smartphone app, to monitor their children’s progress.

The agency authorized EndeavorRx under its De Novo classification pathway, for new types of low- and moderate-risk devices, where no comparable devices or systems already exist. The system is cleared for use with a therapy, medication, or education program guided by a clinician. FDA says it’s the first game-based therapy authorized for any condition.

“With EndeavorRx,” says Eddie Martucci, CEO of Akili in a company statement, “we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment. Families are looking for new ways to help their children with ADHD.”

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