Gamification gathering momentum in health

Phil Taylor highlights some of the latest advances in gamification that are advancing beyond the theoretical and starting to have an impact in health care and management.

Early next month, researchers from around the world will be meeting in the Netherlands to explore how playing computer games can have a positive impact on health.

The Games for Health Europe event has been running since 2011 and this year, in Utrecht, the programme suggests the field has moved beyond the theoretical application of therapeutic games to an implementation phase.

This time, a host of presenters will showcase software and hardware that is being used and validated in a broad range of health applications for diabetes, lung disorders, physical rehabilitation and central nervous system problems, among others, alongside several tools that are used to train healthcare practitioners.

Among the companies showing their technology will be UK firm MyCognition, which has spent years developing an online tool called MyCQ to measure cognitive health, as well as associated games that are intended to enhance cognitive ability.

Much of the company’s work had focused on improving performance in children, but a parallel track in healthcare has already yielded some intriguing results in patients with depression, schizophrenia and obsessive compulsive disorder (OCD).

Clinical validation

MyCognition’s chief medical officer Dr Raj Kumar presented preliminary results from a trial in this mixed patient population, a group which can have cognitive and memory deficits as a consequence of their psychiatric conditions, at the European Conference of Neuropsychopharmacology (ECNP) last month.

In the trial, 19 patients were divided into two groups – one receiving treatment as usual (TAU) and the other allocated to TAU plus cognitive training games, played for at least 30 minutes three times a week for 12 weeks.

The MyCQ assessment was used to gauge performance and baseline, and at the end of the test period in the study, which is ongoing at the Academic Medical Centre in Amsterdam under principal investigator Dorien Nieman.

Kumar told pharmaphorum that the trial was designed to test whether the patients could use the online games, to assess the MyCQ tool and to see whether a change in performance could be detected over the 12-week period.

“We showed that the treatment group improved in certain areas of cognition, such as memory, compared to the control group, and that it was feasible and practical for patients to use the online assessment,” he said.

 

“The treatment group showed a significant improvement in verbal memory performance and a trend towards improvement in visual memory performance”

 

 

Specifically, the treatment group showed a significant improvement in verbal memory performance and a trend towards improvement in visual memory performance compared to the control group. The trial continues and will eventually enrol 80 to 120 subjects, with results due towards the end of 2016.

The study also provided some validation of the MyCQ tool, as it was found to correlate with the commonly-used Cambridge Neuropsychological Automated Test Battery (CANTAB) – a cognition assessment test used for more than 20 years that is, however, time-consuming and often requires a specialist to carry it out.

“This gives us confidence that the MyCQ, which can be completed in 30 minutes, is self-administered and can be accessed at home, has validity,” said Kumar.

The subjects enrolled onto the study will also undergo a batch of physiological tests, including clinical chemistry, as well as activities of daily living (ADL) assessments to give a broad view of the effects of cognitive training.

While still in the early stages, the findings have given confidence to MyCognition to press forward in other clinical areas, and the company is also in the process of organising a trial looking at the use of games to improve cognition in patients diagnosed with Parkinson’s disease.

“Although movement issues are the main pathology in Parkinson’s, most of these patients have difficulties with their cognition as the disease progresses,” noted Kumar, who hopes to start the recruitment process in the coming months.

Meanwhile, the company is also planning to carry out trials in people who abuse substances such as alcohol or drugs, hoping to show that gaming can be incorporated into detox programmes and improve outcomes.

“It is imperative that we demonstrate both the scientific validity and clinical relevance of what we are proposing, and over the next three-to-five years we hope to achieve that in multiple settings, he added.

Regulatory pathways

Aside from proving that the gaming concept works, MyCognition and other developers have to establish how to secure regulatory approval for their products, and then work out how they can be integrated into healthcare systems. In future, they hope that it may be possible that doctors will prescribe a course of gaming therapy in the same way as they currently prescribe medicines.

In essence games for health applications are regulated as medical devices. In the US, that means there is a well-mapped-out route to market via the 510(k) regulatory pathway, with a similar CE Mark route in Europe, and MyCognition is pursuing both of those in parallel.

Companies like MyCognition are treading new ground with their software, however, and it remains to be seen how applicable medical device regulations will be to games, particularly if they want to make a health claim for the product.

 

“To date, the only software approved by the FDA are apps used alongside medical device hardware”

In the US, for example, Akili Interactive Labs is trying to get FDA approval for a game called Evo that could help children and young adults with autism improve attention and motor skills, and is in the midst of a clinical trial that is due to generate results early next year.

The company is hoping to be the first game developer to get a device approval as, to date, the only software approved by the FDA are apps used alongside medical device hardware such as heart monitors, ultrasound scanners, microscopes and thermometers.

According to Kumar, MyCognition will not be looking to make a health claim in the first instance – positioning its game as an adjunct or aid that complements existing treatments if a patient has cognitive deficits.

“We will learn along the way – as will the regulators – and eventually come to a consensus on how these products should be handled,” he predicted, pointing out that 25 years ago there was no agreement on how to measure cognitive gains in dementia patients. Those measurements are now commonplace and have been used in the assessment and approval of several Alzheimer’s drugs.

MyCognition has developed an improved version of the game used in the trial reported at ECNP that adapts to the specific cognitive deficit found in the patient – i.e. attention, psychomotor speed, episodic memory, working memory and executive function.

This new version is now being used in newly-enrolled subjects and provides “more engagement for cognitive remediation,” according to the company. Meanwhile, work is also ongoing to try to integrate the MyCQ assessment into the game itself rather than running it as a separate application, simplifying the testing and training process.

Integration

The hope in future is to link gaming software to wearable technology such as vital sign monitors as well as other linked devices.

One group presenting at Utrecht, for example, has developed a game for patients with respiratory illnesses that includes a breath-actuated device called a GroovTube. When playing the game the subject blows into the device in order to progress and win in-game rewards, training their lungs at the same time.

Aside from generating clinical data, the challenge for MyCognition is to persuade potential healthcare customers as well as groups in the education and business sectors and take out licences to use the software and – particularly in healthcare – to establish a reimbursement process.

“We are working on the best ways to make the technology and products available at the same time as generating data to substantiate their benefits,” said Kumar, who noted that the company is in discussions with pharma companies to explore how its technology could be used to measure change in patients in clinical trials.

A key opportunity for the company has been the shift from laptop to tablet to smartphone as consumers’ device of choice in recent years. Coupled with surging improvements in processing and memory the devices are now much easier to use and can provide data in real-time to investigators.

Overall, MyCognition’s vision is that cognition enhancement games will eventually become an element of the healthcare system, recognising the link between physical and mental wellbeing.

“It is being taken very seriously now that we have to look after our mental state as well as our physical bodies as we live longer and grow older,” said Kumar.

About the author:

Phil Taylor is a freelance writer and journalist covering health, science and technology.

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