From baby boomers fearing memory loss to college students wanting a mental boost, interest in brain-training products is soaring. Yet among leading scientists, there is persistent scrutiny and skepticism. Last year 70 cognitive researchers signed a statement speaking out against computer-based games that promise better cognitive performance, citing a lack of scientific evidence to back such claims.
Within this morass of hype and hope, at least two companies have committed to rigorous testing of their digital products to treat specific health conditions before making them available on the market. Boston-based Akili Interactive Labs and Posit Science in San Francisco are preparing to conduct controlled clinical trials in order to have their therapeutic games approved by the U.S. Food and Drug Administration—a requirement for medical devices that doctors prescribe. The road to FDA approval is long and expensive but promising preliminary studies have encouraged both companies to move forward. The games under development at the two companies emerged from neuroscience and aging research at the University of California, San Francisco (U.C.S.F.).
At the annual meeting of the American Academy of Child & Adolescent Psychiatry on Wednesday, Akili Interactive Labs presented data from a pilot study of its video game, Project: EVO, that showed some positive results in children with attention-deficit hyperactivity disorder (ADHD).
Approximately 6.4 million in the U.S. and one tenth of children worldwide suffer from the condition and struggle with paying attention and controlling their impulses.
The company paid scientists at Duke University School of Medicine and Florida Clinical Research Center to run a four-week study involving 80 children ages eight to 12—40 with ADHD who were not taking medications and 40 neurotypical, or those whose functions were within a normal range. Participants played the game 30 minutes a day for five days a week...
The benefit seen was comparable to what might be encountered for nonstimulant ADHD drugs such as atomoxetine (Strattera). The impact was larger in a subgroup of 22 ADHD kids who were more impaired at the start of the study, Martucci says. Because the cognitive and behavioral analyses were not specified before the study, however, those findings are considered preliminary until confirmed in more rigorous trials.
ADHD experts who were not involved in the study warn the improvements observed in these tests might not carry over into improved functioning in daily life...
The ONTRAC (Online Neuroplasticity Training for Remediation of ADHD in Adolescent Children) study enrolled 31 children with ADHD in New Delhi. About half were taking commonly prescribed stimulant medications. Twenty-one children were randomized to an ONTRAC group and 10 to a placebo group playing nontherapeutic games. Subjects completed three to five half-hour training sessions per week totaling about 30 hours within six months. Compliance was not as good as it was for Akili’s game; 10 of 21 ONTRAC study participants completed less than half of the training. Nevertheless, ONTRAC’s effects on cognition and behavior, judged by different measures, had the same modest effects as Akili’s ADHD group, and persisted when measured six months later. The ONTRAC trial assessed ADHD symptom severity using a parent rating scale, and measured cognitive performance on tests of attention, response inhibition and working memory.
http://www.scientificamerican.com/article/2-companies-seek-fda-approval-for-brain-games-to-treat-adhd2/
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