Children with ADHD showed improvement in attention function after using Akili’s video-game based digital therapeutic EndeavorRx, according to a small study published in PLOS ONE.
The study used EEG scans to measure attentional control and midline frontal theta activity as well as parent-reported symptom trackers. Some of the authors are employees or affiliated with Akili.
“EndeavorRx was designed to target and activate attention networks in the brain with the aim of driving clinically meaningful cognitive changes in patients,” Dr. Anil S. Jina, Chief Medical Officer of Akili. “What’s especially exciting about this data is that, for the first time, we can see how the neural systems of a child with ADHD are impacted with EndeavorRx treatment. We look forward to continuing to learn about how the digital therapeutic can help children with ADHD in their daily lives.”
TOP LINE DATA
The study found that after four weeks of using EndeavorRx children demonstrated improvement on a neural measure of attention, which was measured by EEG scans. Additionally, children’s ADHD symptoms improved on a parent-reported evaluation.
The study was also able to show the “relationships between the neural and behavioral cognitive improvements, demonstrating that those children who showed the largest intervention-related neural gains were also those that improved the most on the behavioral tasks indexing attention.”
“The present findings demonstrate that a targeted, digital therapeutic (AKL-T01) can have wide-ranging positive effects on several metrics of attention in a heterogenous population of children with ADHD,” authors of the study wrote. “Specifically, our primary analyses show that AKL-T01 enhances midline frontal theta (MFT), a well-established EEG-based measure of attentional control.”
A total of 25 children between the ages of 8 and 12 completed the study. The bulk of participants were male (80%). In order to participate children needed to have a confirmed case of ADHD. The study excluded children with brain malformation or injury, movement disorders, psychiatric conditions and hearing impairment. Participants could not be on antipsychotic or ADHD medications for the duration of the study.
Children were given an iPad Mini 2 tablet with EndeavorRx loaded onto it. Participants and their families were instructed to complete five sessions, at least five days a week, for four weeks. This equaled about 25 minutes of time a day.
Researchers assessed children with behavioral and neural outcomes before and after the 4-week long study. Children were asked to do a “perceptual discrimination task that assessed selective attention abilities with concurrent electroencephalography (EEG) recording” both before and after the intervention. Children were also evaluated on the Vanderbilt ADHD diagnostic parent scale, which is made up of parent-reported symptoms.
THE LARGER TREND
Akili landed an FDA De Novo clearance for EndeavorRx in 2020, making it the first gamified digital therapeutic cleared by the agency. Akili has said it will commercially launch the product in the U.S. in the second half of 2022.