ADHD Kids

FDA Approves First-ever Game-based DT Device to Help Children with ADHD

Attention Deficit Hyperactivity Disorder (ADHD) is one of the most common neuro-developmental disorders found among children. It is often diagnosed in childhood and often lasts into adulthood. ADHD affects around 4 million children between the ages of 6–11 years. Common symptoms of ADHD include difficulty paying attention and remaining focused, trouble controlling behavior, and extreme levels of activity. As per the Centers for Disease Control and Prevention (CDC) guidelines, only a trained healthcare professional can make the diagnosis of ADHD and the diagnosis should follow an assessment of pattern of symptoms, which include inattention, hyperactivity, and impulsivity that interfere with normal functioning and development.

In its landmark decision, US Food and Drug Administration (FDA) has given a green light to the marketing and use of the first game-based digital therapeutic (DT) device to help children with ADHD improve their attention function. The Akili Interactive’s EndeavorRX, previously known as Project EVO, is the first-of-its-kind video game which can be legally marketed and prescribed by doctors and professionals as a form of medicine in the US.

video game on iphoneAfter undergoing seven years of clinical trials that studied over 600 children, FDA has authorized doctors to prescribe the iPhone and iPad game for children, between the ages 8 to 12, with mainly inattentive or combined-type ADHD, who have demonstrated issues with attention. Before its authorization as a treatment method, FDA reviewed data from multiple studies conducted on over 600 children, including studies that examined, whether participants exhibited improvements in attention function, as measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools.

The prescription-only game called EndeavorRx has been proven to enhance attention function among children with ADHD, as measured by computer-based testing. It is the first digital therapeutic technique intended to better the symptoms related to ADHD, in addition to being the first game-based therapeutic technique to be granted marketing authorization by the FDA for any sort of condition. The gaming device is proposed to be used along with therapeutic program involving clinician-directed therapy, medication, and/or educational programs, that further address symptoms of the disorder.

Will it work? As per the studies conducted by the company itself, the answer is yes. According to one of the studies, after playing the obstacle-dodging, target-collecting game for 25 minutes a day, five days a week for four weeks, one-third of kids no longer had a measurable attention deficit on at least one measure of objective attention.

As per the developer company, after a month of treatment with the game, improvements in ADHD impairments were maintained for up to a month. Major side effects included seemingly mild frustration, headache, dizziness, emotional reaction, and aggression as compared to traditional drug treatment.

FDA is working on providing timely and easy access to this innovative, easy and safe therapeutic technique to the patients.