FDA approves video game as treatment for ADHD.
The US Food and Drug Administration (FDA) has cleared the first-ever video game to treat ADHD in children.1 EndeavorRxTM (AKL-T01) is a prescription therapeutic gaming device designed to improve inattention or combined-type ADHD in youths between the ages of 8 and 12.2
FDA approval was based on 5 clinical studies involving over 600 participants who had ADHD, including one pivotal study published in The Lancet Digital Health.3 This prospective, randomized, controlled STARS-ADHD study showed that AKL-T01 improved objective measures of attention in children with ADHD. Of 857 children screened for the study, a total of 348 patients with confirmed ADHD were randomly assigned to receive AKL-T01.
The video game-like interface was used 25 minutes a day, 5 days a week, for 4 weeks and was found to improve attentional functioning significantly as reported by both patients and parents. After one month of use, roughly half of parents reported clinically meaningful improvement in their child’s daily impairments. “Moreover, this increased to 68% after a second month of treatment. Following a month of treatment, improvements in ADHD impairments were maintained for up to 1 month,” according to the Akili news release.2 A small percentage of participants experienced minor adverse effects that included frustration, headache, dizziness, emotional reaction, nausea, or aggression.3
EndeavorRx, built on the Akili Selective Stimulus Management engine (SSMETM), is intended for clinical use in concert with therapy, pharmaceutical treatment, and patient education. Playing the game targets neural networks to improve inattention, a central component of ADHD. While hyperactivity is not particularly addressed by the platform, the video game experience activates parts of the brain that compromise cognitive function.
“With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment,” said Eddie Martucci, PhD, Chief Executive Officer of Akili.
Elysa Marco, MD, Assistant Clinical Professor of Neurology and Director of Research, Autism and Neurodevelopmental Center, at UCSF, and Executive Director of Neurodevelopmental Medicine at Cortica Healthcare, added, “Unlike traditional ADHD medications, EndeavorRx is designed to specifically target inattention. Based on the benefits of my research participants and patients have experienced, I am thrilled that EndeavorRx is moving from the lab to the clinic to play an essential role as part of a comprehensive treatment plan for children with ADHD.”
Digital therapeutics for neuropsychiatric disorders have gained momentum since at least 2010, but this is the first-ever device approved by the FDA to be marketed for any condition.4 “Cognitive neuroscience research has the potential to inform the development of novel interventions for specific disorders, such as ADHD, by linking implicated brain systems with specifically-targeted digital interventions, which can be optimally designed to operate within game interfaces,” according to Davis and colleagues.5 Since the COVID-19 pandemic, early approvals of treatments have been made by the FDA, and this is no exception—perhaps because families are looking for alternatives to traditional medications that may or may not work.
The EndeavorRx treatment will be available with a prescription in the near future, according to Akili. The device will be part of the Endeavor Care Program, which includes the EndeavorRx treatment, to be used in conjunction with a mobile app (Akili Care). Information can be found at AkiliInteractive.com.
1. FDA Permits Marketing of First Game-Based Digital Therapeutic to Improve Attention Function in Children with ADHD. Press Release. Federal Drug Administration. June 15, 2020. Accessed June 17, 2020. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd.
2. Akili Announces FDA Clearance of EndeavorRx for Children with ADHD, the First Prescription Treatment Delivered Through a Video Game. Press Release. Akili Interactive; June 15, 2020. Accessed June 17, 2020. https://www.akiliinteractive.com/news-collection/akili-announces-endeavortm-attention-treatment-is-now-available-for-children-with-attention-deficit-hyperactivity-disorder-adhd-al3pw.
3. Kollins SH; DeLoss, PhD; Cañadas E; Lutz J. A novel digital intervention for actively reducing severity of paediatric ADHD (STARS-ADHD): a randomised controlled trial. Lancet Digital Health. 2020;4:e168-e178. Accessed June 19, 2020. https://www.thelancet.com/journals/landig/article/PIIS2589-7500(20)30017-0/fulltext.
4. Robbins R. In a landmark decision, FDA greenlights a video game for kids with ADHD. Stat News. June 15, 2020. https://www.statnews.com/2020/06/15/fda-akili-adhd-endeavorrx. Accessed June 19, 2020.
5. Davis NO, Bower J, Kollins SH. Proof-of-concept study of an at-home, engaging, digital intervention for pediatric ADHD. PLoS One. 2018;13(1):e0189749. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5764249.