Brain training? (Image: Gary John Norman/Getty)

Imagine walking away from a doctor’s office with a prescription to play a video game. Brain Plasticity, the developer of a cognitive training game, has begun talks with the Food and Drug Administration (FDA) to market the game as a therapeutic drug.

Brain Plasticity has been fine-tuning a game to help people with schizophrenia improve the deficits in attention and memory that are often associated with the disorder.

Early next year, they will conduct a study with 150 participants at 15 sites across the country. Participants will play the game for one hour, five times a week over a period of six months. If participants’ quality of life improves at that “dosage,” Brain Plasticity will push ahead with the FDA approval process.


FDA approval for computer games in general – whether for schizophrenia or more common disorders such as depression or anxiety – could change the medical landscape, says Daniel Dardani, a technology licensing officer at the Massachusetts Institute of Technology.

But FDA involvement in the brain game industry will come with pros and cons. Panellists drawn from research and industry debated the issue at a meeting of the Entertainment Software and Cognitive Neurotherapeutics Society in San Francisco earlier this week.

Controversial industry

Some hope that an FDA stamp of approval will add integrity to a controversial industry. “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 at the meeting.

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.

But identifying beneficial games might be a complicated process. Since the Nature study was published, 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.

Unlike the cognitive tasks that featured in the Nature study, the Brain Plasticity game targets a specific section of the population and comes with stringent “dosage” requirements for how often and how long participants need to play to see results.

Game scrutiny

Even if the FDA gives approval for games like Brain Plasticity’s, it might not scrutinise the many games that claim to firm up healthy people’s brains, says Henry Mahncke, a senior scientist at Brain Plasticity.

Some worry that FDA approval would actually stymie development of cognitive training games, because the agency will be too slow to approve the minor tweaks that let games evolve. “I think it’s premature to have the FDA get involved,” says Alice Medalia, a cognitive remediation specialist at Columbia University in New York City.

Compromise may be possible. The FDA could issue guidelines for what consumers should look for in a therapeutic gaming 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.