FDA Approval for Cognitive Video Games?

October 3rd, 2011 by Kel Smith | Filed under Cognitive, Gaming, Nature of Disability, Uncategorized

Children in therapy using the Kinect game console at the Lakeside Center for Autism in Seattle, WA

Children at the Lakeside Center for Autism are using the Kinect as part of their cognitive therapy. Full video can be viewed at http://bit.ly/pK1zIT.

An article this week on NewScientist Health mentions a recent example of video game creators seeking approval from the Food and Drug Administration (FDA) to market their products as therapeutic drugs.

Brain Plasticity (who received $3.65 million in funding in 2010) is a company that has developed a game to help people with schizophrenia improve deficits in attention and memory retention. In early 2012, the company will conduct a 150-person study to determine if a “dosage” of five hours a week makes a measurable impact on patients’ quality of life and mental outlook.

One thought is that the FDA could issue guidance to support claims that certain video games are actually therapeutic product – similar to its handling of medical smartphone apps, says Alvaro Fernandez, CEO of SharpBrains, a Washington DC-based market research firm that tracks non-invasive neuroscience tools.

Talk of FDA-approved video games has created a great deal of intrigue, enthusiasm and controversy. Some medical technologists believe that this development could drastically alter the landscape of mental health. Others believe that “brain games” are a mere fad with little evidence of benefit to the patient:

“The world of brain games is just full of bullshit,” Michael Merzenich, co-founder of Posit Science, a developer of cognitive games told New Scientist. He points to a study last year showing that cognitive training games do nothing for brain fitness (Nature, DOI: 10.1038/nature09042). FDA involvement might help to single out those games with a demonstrable benefit … critics of the study have pointed out that the 11,430 participants were self-selected, healthy and did not follow a strict “dosing” regimen. They believe the games need to be tested more rigorously.

Some cognitive remediation specialists believe that FDA involvement at this time is premature, and that perhaps it’s better to evaluate video games the same way that medical smartphone apps are considered. With “brain gyms” becoming the next big business opportunity out of Silicon Valley and increased attention in general to the cognitively disabled, any possible FDA standpoint is worth watching.

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