The Food and Drug Administration approved a video game to provide digital therapy to children diagnosed with ADHD.
The game is called EndeavorRx, designed by Akili Interactive Labs for children eight to 12 years old who exhibit particular symptoms associated with ADHD and requires a prescription, Akili said in a statement Monday. The game consists of a floating avatar navigating a path constructed of different sensory and motor tasks aimed at developing cognitive functions, The Associated Press reported.
“The EndeavorRx 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, the director of the FDA Center for Devices and Radiological Health, said in a press release Monday.
— Akili Interactive (@AkiliLabs) June 15, 2020
The game will be prescribed as a supplement to medication and other therapeutic and educational plans, according to Akili. Patients prescribed the game will play for 30 minutes daily for five days out of the week to complete the month-long treatment period, Akili said.
EndeavorRx is the first video game to be authorized by the FDA as digital therapy for children with ADHD, the AP reported.
“We’re proud to make history today with FDA’s decision, 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,” said Eddie Martucci, the CEO of Akili, in a statement on Monday.
EndeavorRx was clinically tested five times with over 600 patients who showed an overall increase in performance of attention functions, according to an Akili report.
“No serious adverse” effects were reported during the clinical trials of Endeavor, according to Akili. About 9% of the 538 children participating in clinical trials experienced negative effects including frustration, headache, dizziness, emotional reaction, nausea and aggression.
EndeavorRx should be considered for use as part of a therapeutic program that may include clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder. Find out more https://t.co/9NOQnDhOPp
— FDA Medical Devices (@FDADeviceInfo) June 15, 2020
One-third of patients reported rehabilitation in “at least one measure of objective attention” deficit after completing four weeks of the program, Akili stated.
“For children living with ADHD, improving their ability to focus and resist distraction is critical to their daily functioning and performance in school,” said Clinical Executive for Neurodevelopmental Medicine at Cortica Healthcare Dr. Elysa Marco, according to the release.
Marco added: “Unlike traditional ADHD medications, EndeavorRx is designed to specifically target inattention. Based on the benefits my research participants and patients have experienced, I am thrilled that EndeavorRx is moving from the lab to the clinic to play an essential role as part of a comprehensive treatment plan for children with ADHD.”
Akili did not respond to the Daily Caller News Foundation’s request for comment.
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