A new study shows that children with attention-deficit hyperactivity disorder (ADHD) who underwent a digital treatment in the form of a video game were able to improve their attention skills.
Currently, pharmaceutical drugs and behavioral therapy are the only evidence-based treatments available for ADHD, but these treatments may not be effective for all individuals and access to providers can be limited. According to the researchers, an innovative digital treatment could fill these gaps for many families.
Scientists from the Duke Clinical Research Institute (DCRI) designed and led the 350-patient study to determine whether children ages eight to 12 with ADHD might benefit from the treatment. The game, produced by Akili Interactive Labs, Inc., involves racing through a course, dodging obstacles, and capturing rewards to advance to the next level.
An initial trial shows that children who received the treatment performed better on attention tests after four weeks compared to children who played a game designed as a comparative control.
The company announced its plans to submit the digital treatment, currently called AKL-T01, to the U.S. Food and Drug Administration for review as an approved medical device to treat ADHD in children.
“Software or game companies have marketed products they say can improve attention, but to date, none of these products have gone through the rigorous testing required by the FDA to become an approved treatment for ADHD,” said principal investigator Scott Kollins, Ph.D., a member of the DCRI and director of the ADHD program at the Duke University School of Medicine.
“This study represents, to my knowledge, the largest and most rigorous evaluation of a digital medicine,” he said. “Continued work on this approach could mean that in a few years, doctors could be prescribing a therapeutic video game to improve a patient’s ADHD symptoms.”
Although the initial findings are promising, the full study data require in-depth analyses, which researchers plan to present at an upcoming scientific conference and submit to a peer-reviewed medical journal, Kollins said.
AKL-T01, which children can use on a tablet at home, requires quick reaction time and decision-making skills and increases in difficulty in response to the player’s ability. The game was designed to target parts of the prefrontal cortex that assist in cognitive control and are believed to be deficient in ADHD.
Children who took part in the treatment showed a statistically-significant improvement compared to a control group on the Test of Variables of Attention (T.O.V.A.®), an FDA-cleared test to measure attention and impulse control.
The participants, who were not receiving drugs or other therapies, took the test before using the device and again after four weeks. One participant withdrew from the study early, while 11 others reported experiencing headaches and frustration, but no serious negative side effects were reported.
Participants were also evaluated using other methods to detect improvements in their attention and behavior, but differences between treatment and control groups on these measures were not statistically significant, the researchers said.
“This study demonstrates just how fast medical care and clinical research are changing,” said Eric Peterson, M.D., executive director of the DCRI. “While digital medicine represents a promising approach to treat many conditions, these treatments need to be rigorously tested and proven, just like other drug and device therapies.”
Source: Duke University