A prescription, digital therapeutic shows measureable brain changes that correlate with improved attention control in children with attention deficit hyperactivity disorder (ADHD).
Investigators found children who used the video game-based therapy (EndeavorRx) experienced increased brain activity related to attention function, as measured by EEG, which correlated with improvements in objective behavioral measures of attention.
“While the previous multicenter trials show attention improvement for children using EndeavorRx, this is the first study to look at the brain activity in children with a primary concern of ADHD,” principal investigator Elysa Marco, MD, clinical executive for neurodevelopmental medicine at Cortica Healthcare, San Rafael, California, said in news release.
“It is exciting to see measurable improvement on the EEGs that correlates with the behavioral benefits,” said Marco.
The study was recently published online in PLOS ONE.
As previously reported by Medscape Medical News, the US Food and Drug Administration (FDA) approved EndeavorRx in June 2020 as a prescription video game-based therapeutic device for children aged 8-12 years with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue.
“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 FDA said upon approval.
In the current unblinded, single-arm study, the researchers assessed 25 children (aged 8-12 years) with a confirmed diagnosis of ADHD on neural, behavioral, and clinical metrics of attention before, and after, a 4-week at-home intervention.
Participants were instructed to use EndeavorRx for about 25 minutes a day at least 5 days a week for 4 weeks, as recommended by the FDA.
“EndeavorRx enhanced midline frontal theta (MFT) activity, suggesting that patients who used EndeavorRx for 4 weeks showed changes in measurable brain function,” Anil S. Jina, MD, chief medical officer of Akili Interactive, told Medscape Medical News. Jina was not involved with the study.
There was also a correlation between MFT activity and attention functioning, “suggesting that children who experienced the largest gains in MFT activity as measured by EEG also showed the greatest improvements in computerized performance tests designed to measure attention,” Jina said.
In addition, parents reported significantly fewer inattention symptoms in children after EndeavorRx treatment, as measured by the Vanderbilt ADHD Diagnostic Rating Scale.
“Not Just Another Video Game”
EndeavorRx has been evaluated in five clinical studies involving more than 600 children with ADHD, including the STARS-ADHD trial, a prospective, randomized, controlled study published in The Lancet Digital Health.
The STARS-ADHD trial randomly allocated 348 children to either EndeavorRx treatment or a controlled intervention, which was a word game.
The researchers reported statistically significant improvements in attentional functioning in EndeavorRx group group as rated by test of variables of attention.
“This not just another video game,” STARS-ADHD trialist Scott H. Kollins, PhD, MS, a clinical psychologist at Duke Health’s ADHD Clinic in Durham, North Carolina, who helped developed it, previously told Medscape Medical News.
The tool’s adaptive algorithms adjust and monitor task difficulty based on performance, using a video game format and rewards to engage users, he explained. EndeavorRx is a challenge to play by design.
“The treatment was programmed into the gameplay experience and designed to challenge a child’s attentional control during gameplay, requiring focus and flexibility to manage tasks at the same time,” Jina told Medscape Medical News.
“Unlike a video game that is designed only for entertainment purposes, to drive efficacy, EndeavorRx is designed to be challenging and can therefore sometimes feel repetitive, and frustrating to some children,” Jina said.
Commenting on the study for Medscape Medical News, Stephen Faraone, PhD, distinguished professor of psychiatry and vice chair of research, Department of Psychiatry, SUNY Upstate Medical University, Syracuse, New York, said this study “supports the idea that EndeavorRx improves a neural measure of attention.”
“The limitation is that we don’t know if this translates into clinically relevant outcomes,” cautioned Faraone, who was not associated with the current study.
“The main caveat about EndeavorRx is that it was cleared by the FDA for improving a computer-based measure of inattention, not inattentive symptoms as reported by the parents of children with ADHD,” he noted.
Funding for this study was sponsored by Akili Interactive Labs. Several authors have disclosed financial relationships with the company. Faraone was an investigator on the STARS-ADHD trial.
PLOS ONE. Published online December 31, 2021. Full text
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