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


 
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Matthew WilsonI think its a good article, and devs can take some lessons from life is strange.04/24/2015 - 10:24pm
Andrew EisenI tinyURL'd it. The world is safe!04/24/2015 - 10:23pm
Matthew Wilson@AE my bad there is nothing I can do about that.04/24/2015 - 10:21pm
Andrew EisenLooks like the spoiler is right there in the URL.04/24/2015 - 10:20pm
Matthew Wilsonhttp://tinyurl.com/ok9pf6b a interesting opinion piece on the life is strange episode 2, and a dark event that happens in it. full warning major spoilers.04/24/2015 - 10:11pm
Matthew Wilson@mech no just she, nor her co workers have not. she never said it is not real.04/24/2015 - 8:58pm
MechaCrashWas she saying "I haven't experienced it," or "I haven't experienced it therefore it does not exist"?04/24/2015 - 8:31pm
ZippyDSMleeoy the skyrim paid mod thing is going over well. My 2 lints, I would not mind if Skyrim had a full SDK and not a crappy lil editor....04/24/2015 - 6:46pm
Andrew EisenWell, that is indeed crappy and nonsensical.04/24/2015 - 3:45pm
Matthew Wilsonshe got attacked for saying that she personaly has not experienced the harassment some other female devs have, and she got acused of defending GG and ignoring harassment. she ended up getting dog piled because of it.04/24/2015 - 3:43pm
Andrew EisenFine but do you recall ANY details at all?04/24/2015 - 3:38pm
Matthew Wilsonit was several weeks ago now, and I will admit to not saving it.04/24/2015 - 3:36pm
Andrew EisenAttacked HOW and by WHOM for not writing off WHO as evil? Do you have a link or anything?04/24/2015 - 3:31pm
Matthew Wilsonthat is the whole point she was not attacked for saying anything. she was attacked for being willing to debate in the first place, and not just write them off as evil.04/24/2015 - 3:28pm
Andrew EisenI know there's not a lot of room in the Shout box but goodness you're being vague.04/24/2015 - 3:26pm
Andrew EisenGreat, but that STILL doesn't tell me what she said, why she was attacked (or what the attack was) or what "standard line" she's following. Details, man. Details!04/24/2015 - 3:25pm
Andrew EisenOr what the heck Nina White (someone else I've never heard of) is actually referring to.04/24/2015 - 3:24pm
Matthew Wilson@AE she is a game dev. she used to do stuff with hormanix and now works with https://outact.net/#!/?page_id=2 she will often engage and debate both side.04/24/2015 - 3:23pm
Andrew Eisen...following.04/24/2015 - 3:23pm
Andrew EisenYou mean focus on stopping the bad behavior of those who are doing it rather than condemning all the people that associate with them? Great. But I still don't know who Emma Clarkson is, what she said, why she was attacked or what "standard line" she's04/24/2015 - 3:23pm
 

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