Could This Be the First FDA-Approved Video Game for ADHD?
A new adaptive video game, intended as a new treatment for pediatric ADHD, showed such positive results in a mid-sized study that its parent company plans to file for FDA approval in 2018.
December 18, 2017
The Boston-based company Akili Interactive announced last week that its therapeutic video game improves attention and self-control in children with ADHD, according to a preliminary study. Buoyed by these findings, Akili Interactive plans to file for FDA approval of it tablet-based AKL-T01 in early 2018, hoping it becomes the first FDA-approved video game in the United States.
The tablet-based AKL-T01 game — marketed as “digital medicine” — uses an adaptive algorithm to present players with stimuli that activates targeted areas of the pre-frontal cortex. Apart from that feature, the company says, AKL-T01 looks and feels like other commercially designed video games with storytelling and rewards features.
The study, entitled STARS-ADHD, was a randomized, controlled trial involving 348 children aged 8 to 12 who had been diagnosed with ADHD. The children were assigned to play either AKL-T01 or a “control” game for four weeks. The control game followed a similar format as AKL-T01, the company said, but lacked its therapeutic stimuli.
After four weeks, the children were tested using the Test of Variables and Attention (TOVA), a common measure of ADHD symptom severity. Children who had been assigned to play AKL-T01 showed a statistically significant improvement in their TOVA scores, the company said, while children in the control group saw no improvement. Parent reports of symptoms were also taken into account, but showed no significant difference between the two groups. AKL-T01 was generally well tolerated; reported side effects included headache and frustration. Just one participant dropped out of the study before it was complete.
“This innovative study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” Scott Kollins, Ph.D., the principal investigator of the study, said in a statement. “The objective improvements of attention observed in the study suggest that AKL-T01 addresses a key deficiency in ADHD that is not directly targeted by standard treatments.
“Since the active control group in this study also played an engaging video game,” he continued, “we are encouraged that the statistically significant group differences were drive by the therapeutically active component in AKL-T01 and not just the video game experience.”
The results of the study will be submitted for publication in a peer-reviewed journal.