Brain Plasticity Seeks FDA Approval for Brain Game

September 27, 2011 -

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


 
Forgot your password?
Username :
Password :

Poll

Should 'Hatred' have been removed from Steam Greenlight?:

Shout box

You're not permitted to post shouts.
Matthew WilsonI hope its released to netflix or amazon12/18/2014 - 12:11am
prh99Basically they've given every tin pot dictator and repressive regime a blue print how to conduct censorship abroad. The hecklers veto wins again. At least when it comes to Sony and the four major theater chains.12/17/2014 - 11:55pm
MaskedPixelante"It's not OUR fault that our game doesn't work, it's YOUR fault for having so many friends."12/17/2014 - 9:48pm
Matthew Wilsonapparently tetris did not work because he has a full friends list12/17/2014 - 9:21pm
WonderkarpSo Sony cancelled the release of the Interview. was it ever confirmed that the Sony hacking was done because of that specific movie?12/17/2014 - 8:54pm
MaskedPixelanteWow, Ubisoft went four for four, I didn't think it was actually possible.12/17/2014 - 8:37pm
MechaTama31Oh, ok, I was mixing up "on Greenlight" and "Greenlit".12/17/2014 - 8:23pm
Matthew Wilson@phx you beat me to it. how do you screw up tetris?! my ubisoft this is just stupid. no one should ever preorder a ubisoft game again! ps people should never preorder any game regardles of dev.12/17/2014 - 6:28pm
PHX Corphttp://www.ign.com/videos/2014/12/17/what-the-heck-is-wrong-with-tetris-ps4 I give up on ubisoft12/17/2014 - 6:01pm
MaskedPixelantehttp://comicbook.com/blog/2014/08/16/exclusive-original-unaltered-cut-of-star-wars-trilogy-to-be-rele/ Yeah, this'll never happen.12/17/2014 - 5:03pm
NeenekoThey have and exercise control over which games are allowed on their privately controlled 'open forum'. Their endorsement is fairly minimal since it is only 'we do not reject this', but it is still an endorsement of sorts.12/17/2014 - 3:58pm
NeenekoHistorically there have been issues with libraries allowing some groups but not others. Perhaps 'endorsement' is too strong a word, but their editorial control IS a preapproval process, even if the standards are pretty minimal.12/17/2014 - 3:56pm
E. Zachary KnightLet's put this a different way. My local library allows any group to reserve and use multipurpose rooms. That does not mean that the Library endorses all events that take place in those rooms.12/17/2014 - 12:54pm
E. Zachary KnightValve's editorial control comes from removing problem games and accepting games to Steam. They make no claim over any games otherwise.12/17/2014 - 12:52pm
E. Zachary KnightNeeneko, It is not at all a form of endorsement. Grenlight is an open forum for game developers to pitch their game to Valve/Steam and Steam users. Does Valve have some editorial control? Yes, but not to the point that they preapprove games.12/17/2014 - 12:51pm
Neeneko@EZK - I disagree. Greenlight is built off Valve's brand. While not an explicit endorsement, it is a form of it, otherwise Greenlight would have no value over other platforms.12/17/2014 - 12:05pm
MaskedPixelantehttp://www.latino-review.com/news/exclusive-viola-davis-bags-amanda-waller-role-in-suicide-squad Latino Review says Viola Davis will be Amanda Waller. History of Latino Review says "wait for a REAL news site to confirm".12/17/2014 - 10:48am
PHX Corphttp://www.polygon.com/2014/12/17/7407869/assassins-creed-unity-glitch-broken-problems-xbox-one-patch -Facepalm- Screwup means Assassin's Creed Unity's patch is the 40GB full game on Xbox One12/17/2014 - 10:17am
PHX Corphttp://www.theverge.com/2014/12/16/7401769/the-mpaa-wants-to-strike-at-dns-records-piracy-sopa-leaked-documents Sony leaks reveal Hollywood is trying to break DNS, the backbone of the internet12/17/2014 - 10:05am
E. Zachary KnightA Game being on Greenlight is not an endorsement of said game by Valve, Steam or anyone related to Valve or Steam. Greenlight is a combined sales pitch to Steam and its users.12/17/2014 - 9:51am
 

Be Heard - Contact Your Politician