A video game-like interactive program evidences promise in proof-of-concept study prior to FDA review as a medical device to treat children with ADHD.
Scott Kollins, PhD
A video game-like interactive program that targets neurocognitive processes has evidenced promise in a proof-of-concept study prior to review by the US Food and Drug Administration (FDA) as a medical device to treat children with attention-deficit/hyperactivity disorder (ADHD).
The investigational program AKL-T01 (Project EVO, Akili Interactive Labs) is designed to improve attention and inhibitory control and is described as "a first-of-its-kind prescription digital medicine being evaluated as a potential treatment for ADHD," in a statement released by Akili Interactive Labs and reported by MD Magazine in December.
According to principle investigator Scott Kollins, PhD, Professor and Vice Chair for Research Strategy & Development, Department of Psychiatry and Behavioral Sciences, Duke University School of Medicine, Durham, North Carolina, the AKL-T01 program is an updated digital treatment based on the NeuroRacer model that deploys the interference-based cognitive control-targeting mechanism in an action video game-like interface.
"The intervention was developed using high-quality graphics and reward loops designed to be engaging for children," Kollins said. "Additionally, the intervention embeds algorithms that continuously adapt to cognitive control ability and provide feedback on progress and compliance."
The proof-of-concept study showed that 84% of treatment sessions were completed and that the intervention was appealing and well accepted. Significant improvements were found in the computerized attention task and spatial working memory for the ADHD group and a highly impaired ADHD High Severity subgroup, while there was no change for the non-ADHD group.
"Results of the current study are particularly important given that medication management, the most commonly utilized treatment for ADHD, has a very significant effect on core symptoms of ADHD but only equivocal effects on specific executive function," Kollins and colleagues pointed out. "Given the limitations of existing therapies in remediating these challenges, the current study demonstrates an important step toward increasing therapeutic options for children with ADHD and executive dysfunction."
The proof-of-concept study published in January assessed the acceptability and some outcomes of the program in 40 children with, and 40 children without ADHD. This study could be considered a medical device counterpart to a medication phase 2 trial, which evaluates safety and effects on a relatively small population before proceeding to a phase 3 controlled clinical trial in a larger population.
The larger, but currently unpublished controlled trial of the interactive program, the STARS-ADHD study, compares efficacy of the AKL-T01 to the placebo-control of a similarly engaging video game designed for entertainment rather than therapeutic effect. The results of that study are encouraging, according to the statement released by Akili, and will be pivotal to an application to the FDA, which is likely to seek clearance as a medical device through the 510(k) section of the Food, Drug and Cosmetic Act.
In the proof-of-concept study, Kollins and colleagues sought to determine whether the AKL-T01 interactive program on a tablet computer would be sufficiently appealing for repeated home-based use, and to explore whether it could impact ADHD impairments through direct cognitive training.
"An array of cognitive training programs has been promoted to address the specific cognitive processes that are impaired in ADHD," Kollins and colleagues observed. "To date, however, despite promising findings from individual studies of such methods, equivocal findings from meta-analyses have been reported, such as inadequate generalizability of effects outside of training and the limitations of addressing cognitive processes versus core symptoms."
The investigators credit the basis for the development of AKL-T01 to a series of studies by Adam Gazzaley, MD, PhD, Professor of Neurology, Physiology and Psychiatry, University of California, San Francisco (UCSF), and colleagues, which identified critical neural processes underlying cognitive control ability, and demonstrated that a game-like intervention (NeuroRacer, Neuroscape/UCSF) could specifically target this system to achieve cognitive remediation.
Gazzaley, who is also Chief Scientific Advisor at Akili, spoke to the therapeutic potential of such interventions in a TEDX presentation at the outset of the STARS-ADHD study. "What I hope we'll see is a whole new category of 'digital medicine'," Gazzaley said. "Video games are so exciting to us because they activate brain networks in a selective way; something that we've never successfully done with a small molecule (drug)."
The proof-of-concept study of a video game-like interactive intervention for pediatric ADHD was published January 11 in PLOSone.
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