Image by Nadine Doerlé from Pixabay
June 16, 2020 - By Laura Kurtzman - The U.S. Food and Drug Administration has approved the first video game therapeutic as a treatment for attention deficit hyperactivity disorder (ADHD) in children, based on research by UC San Francisco’s Adam Gazzaley, MD, PhD.
In 2013, Gazzaley published a paper in Nature reporting that six weeks of training with a video game called Neuroracer, in which the player seeks to discern relevant cues from distracting ones during a car race simulation, improved attention in older adults. The results were striking, given that attention markedly declines with age.
Gazzaley believes that enhanced function in a brain network involved in cognitive control, which is necessary to pursue goals, explains the improvements, both in the older adults he studied and in the children who can now be treated with a kids’ version of the technology, called EndeavorRX. Gazzaley is a co-founder of Akili, which produces EndeavorRX, and which conducted clinical trials of the game as an ADHD treatment with researchers Duke University.
In the 2013 research, Gazzaley’s lab measured low-frequency brain waves in the prefrontal cortex, as well as the coherence between frontal and posterior regions of the brain. As the older drivers in Neuroracer became more adept at the multitasking challenges of the game, their brains modulated this key neural network so that it came to resemble the activity seen in the brains of young adults.
“The Neuroracer study published in Nature formed the basis of the patent that Akili’s EndeavorRx is based on,” said Gazzaley, who directs the Neuroscape Center at UCSF and is a professor of neurology, physiology and psychiatry. “Of course, there has been much development and many more studies since then – not all of which, including the ADHD research, we did. But this is our technology at its core.”
Source: UCSF
FDA Press Release:
FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD
On Monday, the U.S. Food and Drug Administration (FDA) permitted marketing of the first game-based digital therapeutic device to improve attention function in children with attention deficit hyperactivity disorder (ADHD). The prescription-only game-based device, called EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue. EndeavorRx is indicated to improve attention function as measured by computer-based testing and is the first digital therapeutic intended to improve symptoms associated with ADHD, as well as the first game-based therapeutic granted marketing authorization by the FDA for any type of condition. The device is intended 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.
“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,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”
ADHD is a common disorder that begins in childhood, affecting approximately 4 million children ages 6-11. Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and very high levels of activity. According to the Centers for Disease Control and Prevention, diagnosis of ADHD should be conducted by a trained health care professional and follow an evaluation of symptoms or pattern of symptoms, such as inattention, hyperactivity, and impulsivity that interfere with functioning or development.
The FDA reviewed data from multiple studies in more than 600 children, including studies that evaluated, among other things, whether participants demonstrated improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools. There were no serious adverse events reported. The most common adverse events observed with EndeavorRx are: frustration, headache, dizziness, emotional reaction, and aggression.
The FDA reviewed the EndeavorRx through the De Novo premarket review pathway, a regulatory pathway for low- to moderate-risk devices of a new type. This action creates a new regulatory classification, which means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.
The FDA granted marketing authorization for the EndeavorRx to Akili Interactive.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Source: FDA
