Brain Plasticity Seeks FDA Approval for Brain Game

Video game developer Brain Plasticity is seeking approval from the Food and Drug Administration (FDA) for a cognitive training game because it wants to market the game as a therapeutic drug. The company has been working on a game to help people who suffer from schizophrenia improve attention and memory deficits that are often associated with the disorder. The company plans to 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 could change the medical landscape, says Daniel Dardani, a technology licensing officer at the Massachusetts Institute of Technology. Some believe that an FDA stamp of approval will add integrity to therapeutic video game products, but some strongly disagree:

“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 a meeting earlier this month.

He points to a study last year showing that cognitive training games do nothing for brain fitness at all. That aside, FDA approval could prove to stymie the ongoing development process, because the agency is not known for its expedience review and approval process. Some think that having the FDA involved at this point in the sector’s relative infancy is just not a great idea.

“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.

The FDA could issue guidelines for what consumers should look for in a therapeutic video game similar to the way the agency handles medical smartphone apps, notes Alvaro Fernandez, CEO of SharpBrains, a Washington DC-based market research firm that tracks non-invasive neuroscience tools.

Source: New Scientist

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