Akili Interactive has published data from its STARS-Adjunct trial supporting the efficacy of EndeavorRx, its attention-deficit hyperactivity disorder (ADHD) video game therapy for kids, in the peer-reviewed journal Nature Digital Medicine.

The multi-centre, open-label study of EndeavorRx (AKL-T01), along with data from four other trials, supported approval of the app and video game combination in Europe and the US last year.

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The “prescription video game” strives to improve paediatric patients’ ability to focus by challenging them to manage competing tasks and to shift attention between them while harnessing colourful graphics and visuals most kids would be used to from the video games they play in their everyday lives.

The therapy is for use on tablet devices and uses digital rewards to keep users motivated and interested.

“AKL-T01 is built on our Selective Stimulus Management (SSME) engine that deploys specific sensory stimuli and simultaneously assesses patient motor responses,” Akili Interactive CEO Dr Eddie Martucci explained to Medical Device Network back in 2019 when the firm’s application was pending approval from the FDA.

“Specific adaptive algorithms are engineered in the product to ‘drive’ the SSME engine and deliver the stimuli that engage targeted neural systems in the prefrontal cortex by forcing the brain to manage multiple streams of information simultaneously in an environment of ever-increasing complexity. In a closed-loop system, the algorithms adapt in both real-time – during gameplay – and between treatment sessions to automatically adjust the level – or dose – for a personalised treatment adapted to the needs of each individual patient.”

In the STARS-Adjunct trial, 206 children aged 8-14 played EndeavorRx five days a week for four weeks, followed by a four-week pause and then another four weeks of treatment.

The effect of Akili Therapeutics’ digital therapy was measured using the official ADHD Impairment Rating Scale (IRS), and measures reported by parents on daily life activities.

The results found that after the first treatment period, children showed reductions in impairment in their daily activities and ADHD symptoms, remained stable while off treatment and then improved again after a second treatment.

According to the researchers, half of the children showed a response to treatment after one month, while 68% showed a clinical response after the second treatment phase.

Notably, the STARS-Adjunct trial observed a benefit for EndeavorRx regardless of whether the children were taking ADHD stimulant medication or not – a measure that was not looked at in earlier trials of the game.

The unmedicated group showed a 50% improvement on IRS, while the group on stimulants had a 30% improvement.

“Given that the majority of children diagnosed with ADHD take medication to help manage their condition, it is important to evaluate the effects of new non-pharmacological interventions in the context of routine care,” wrote the authors of the study.

While ADHD is a very common condition, affecting around 5% of people worldwide, there are multiple barriers to accessing treatment.

Many people and parents experience difficulties in getting a diagnosis and the waiting lists are often very long. There is also a huge lack of properly trained staff and the condition is plagued by stigma and misunderstanding. While there are multiple stimulant medications available to improve executive function, many patients are unable to tolerate it and some experience severe side effects.

EndeavorRx is part of a changing tide in therapeutics for ADHD and other neurological conditions that have the potential to be treated with behavioural interventions rather than with medication alone.

While the results from the STARS-Adjunct trial are positive, the study’s authors said further studies “are necessary and underway” as the study had no blinded control group and excluded children with significant comorbid conditions such as oppositional defiant disorder, anxiety and mood/personality disorders.

Detailed data on the therapy’s long-term effects will also be required, the authors said. The duration of the study was only three months while ADHD is a lifelong, chronic condition.

“These limitations notwithstanding, the present study adds to the growing evidence base for the potential benefits of AKL-T01 in pediatric ADHD,” wrote the authors.

“The continued examination of the extent of treatment effects, as well as the generalizability and durability of effects will be important. As noted, continued evaluation of the effects of AKL-T01 on other important aspects of functioning like academic and social functioning, health utilization and health outcomes would continue to add to the evidence base that the effects observed in this and previous studies have substantial clinical and functional impact.”