08 Jan 2016

Brain-training software has become big business, pulling in billions in revenue despite limited evidence to date on how well it works. Now regulators are stepping in to rein in the advertising. The U.S. Federal Trade Commission announced January 5 that it had slapped brain-training company Lumos Labs with a $2 million fine for what it called “deceptive advertising” of its Lumosity software. According to the FTC, the marketing campaign implied that use of the software could ward off cognitive decline and dementia, without adequate data to back up these claims. As part of the settlement, Lumos Labs must inform customers of the FTC action and offer them an easy way to cancel software subscriptions. The ruling has received extensive media coverage (see, e.g., The Wall Street Journal and NBC News).

The FTC’s action follows other recent rulings curbing marketing claims by software manufacturers. In January 2015, the agency ordered Focus Education to stop claiming that its Jungle Rangers computer game improved memory, focus, and school performance in children, and in September it imposed a $150,000 fine on Carrot Neurotechnology, Inc., for claiming its software could improve vision.

The latest ruling met with broad approval from experts in the cognitive-training field, who seconded the need for stronger scientific evidence of software efficacy. “I hope these FTC findings will lead to more rigorous testing of the benefits of brain-training programs. Ideally, they also will motivate companies to limit their marketing claims to those directly supported by well-designed intervention studies,” Daniel Simons at the University of Illinois in Urbana-Champaign wrote to Alzforum. Murali Doraiswamy at Duke University, Durham, North Carolina, suggested that brain-training companies seek FDA clearance before marketing their products as cognitive enhancers. Doraiswamy has consulted for Lumos Labs on the design of validation studies as an unpaid advisor.

Marketing claims lay at the crux of the Lumosity decision. The FTC charged that Lumos Labs’ ads gave the impression its software could improve performance in school, athletics, and on the job, delay age-related decline and dementia, and ameliorate cognitive impairment associated with health conditions such as stroke and traumatic brain injury. “Lumosity preyed on consumers’ fears about age-related cognitive decline … but did not have the science to back up its ads,” the FTC’s Jessica Rich said in a statement. The company also failed to inform consumers that some testimonials on its website were submitted in response to prize contests, the FTC said.

Representatives of Lumos Labs were unavailable to speak, but sent a prepared statement. It noted that the FTC inquiry dealt with “certain advertising language used in previous marketing campaigns,” and affirmed the company’s commitment to conduct research on the effects of its cognitive-training programs.

What does the research say? A number of papers report that brain-training software can improve cognitive abilities in the specific areas being trained, or in closely related domains. Most recently, Lumos Labs published a study on nearly 5,000 healthy elderly adults who either used its software or did crossword puzzles as a control five days per week for 10 weeks. Afterward, the software users performed better on neuropsychological tests measuring problem solving, processing speed, and short-term and working memory, the study concluded (see Hardy et al., 2015).

However, experts stress that the real question is whether such gains translate to meaningful improvements in everyday life. No such data is published for the Lumosity products, or most other computer game approaches. Even more broadly for brain training, few studies demonstrate a clear functional benefit. The Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE) study supported by the National Institutes of Health did find that healthy elderly participants who received six weeks of personalized training from researchers in reasoning and processing speed maintained those skills better than controls up to 10 years later. The experimental group self-reported better ability to handle everyday tasks than controls did; however, objective tests of their speed and efficiency found no difference between the groups (see Rebok et al., 2014; NIH press release).

Whether brain gaming software can slow cognitive decline remains even murkier. Only a handful of small studies have examined the effects of the Lumosity program in cognitively impaired people. These studies reported some improvements in the trained cognitive domains, but no clear functional benefit (see Jun 2014 news).

Marketing by the brain-training industry has already caused cognitive scientists to distance themselves from claims about brain gaming products. In 2014, 75 scientists signed a consensus statement jointly issued by the Berlin Max Planck Institute for Human Development and the Stanford Center on Longevity. It concluded “there is no compelling scientific evidence to date” that brain games can prevent cognitive decline. Parts of this statement irked other scientists in the broader field of cognitive training, however, and 133 of them offered a dissenting opinion, arguing that some specific interventions do bolster cognition and deserve further study.

Resolving the question may take time because the accepted gold standard, randomized controlled trials, is difficult to apply to brain-training games. John Harrison of Metis Cognition, Wiltshire, U.K., noted that the placebo group would have to receive a cognitive intervention that looked and felt like the treatment, but had no effect. “That is hard to imagine,” Harrison wrote. He and others argued against abandoning research on brain-training strategies. “The risk of rejecting the possibility that training works is that we might be throwing away one of the possible tools in our armamentarium for dealing with dementia,” he wrote (see full comment below).

In the meantime, some researchers in the Alzheimer’s field are making use of Lumos Labs’ software. The University of San Francisco’s Brain Health Registry incorporates Lumosity’s Neurocognitive Performance Test in its suite of cognitive assessments to track cognitive change in users over time (see Dec 2014 conference news). A public-relations spokesman for the registry told Alzforum the FTC ruling will not affect the registry’s use of the software.

Does the FTC ruling affect other companies entering the brain-training field? Not directly, but it reinforces the importance of demonstrating efficacy. Adam Gazzaley of the University of California, San Francisco, co-founded software company Akili Interactive Labs to develop cognitive interventions and diagnostics in the form of video games. Akili does not yet have a product and has not done any marketing, or received any attention from the FTC, Gazzaley said. He previously designed NeuroRacer, a video driving game that required multitasking and boosted untrained but related abilities of attention and working memory in healthy adults (see Sep 2013 news). Gazzaley believes cognitive training can offer real benefits. “I remain cautiously optimistic that with high-level development and careful validation, we will create a new category of cognitive enhancement tools for both healthy minds and those suffering from deficits,” he wrote to Alzforum (see full comment below).—Madolyn Bowman Rogers

Comments

- John Harrison
  Metis Cognition Ltd.
- Posted: 08 Jan 2016
With respect to training cognition, we’ve known for millennia that using mnemonics is a very efficient way of remembering information. Thus, if I taught someone to use this technique, we’d likely see a marked increase in their memory skills and I think we might legitimately claim to have trained their cognition. However, the topic of modern "brain-training" programs and their efficacy is highly contentious.

To illustrate this, back in 2014 a group of 75 scientists wrote suggesting there is no evidence of efficacy. A little later, 133 equally well-known commentators put their name to a statement suggesting that there was something to the idea. I think the reason for the disagreement is because no critical experiment has been reported to unequivocally address the efficacy issue. The usual gold standard for evidence is to run a randomized, double-blind, placebo-controlled trial, as we would do with a new chemical entity. However, given the nature of brain-training interventions, it is hard to envisage a truly double-blind, placebo-controlled trial. Thus the efficacy of brain training must remain a matter of belief.

From the FTC’s ruling it is clear that they are unconvinced, and they gave fair warning last year when their spokesperson stated in the context of their judgment on Jungle Rangers: "This case is the most recent example of the FTC’s efforts to ensure that advertisements for cognitive products, especially those marketed for children, are true and supported by evidence." Given the lack of clear evidence one way or the other, it seems to me that agnosticism is the appropriate position. However, the risk of rejecting the possibility that training works is that we might be throwing away one of the possible tools in our armamentarium for dealing with dementia, and arguably just at the time when we need such tools the most.

My view is that if people believe that if brain training works for them, then there is no problem with companies providing brain training technology on a "buyer beware" basis.

View all comments by John Harrison

- Adam Gazzaley
  UCSF
- Posted: 09 Jan 2016
I think it is critical that companies that create tools to enhance human performance, not just those developing clinical treatments, conduct rigorous scientific studies to validate their offerings, as well as make sure that their marketing claims are in line with that evidence. The assessment of how well they have accomplished this should be done by a regulatory agency on a case-by-case basis, but with input from the scientific community.

I would add that I am concerned cases like this may lead the baby to be thrown out with the bathwater. There are emerging findings that suggest cognitive training via interactive media (e.g., video games) can have a positive impact of cognition. But there is still much work to be done, and this does not mean that every tool will be equally effective. I remain cautiously optimistic that with high-level development and careful validation, we will create a new category of cognitive enhancement tools for both healthy minds and those suffering from deficits.

View all comments by Adam Gazzaley

- Jean-François Foncin
  Ecole Pratique des Hautes Etudes
- Posted: 12 Jan 2016
The contradictions in claims for and against "brain training" arise out of the confusion between symptoms and disease. "Cognitive-enhancement tools" may be effective, for a time, against memory loss and other symptoms of age-related cognitive deficiency, but are obviously of no effect against the evolution of any of the various diseases that cause these symptoms.

View all comments by Jean-François Foncin

- Thomas Dannhauser
  University College London
- Posted: 20 Jan 2016
Dementia prevention is a health priority and I support all reasonable efforts working toward it. Just as dementia is caused by several different underlying conditions, preventing it will probably rely on different approaches and methods that could include cognitive training.

In the U.K., the leading experts and policy makers in dementia published the Blackfriars Consensus Statement on Promoting Cognitive Health in 2014 (Lincoln et al., 2014). It concluded that promising behavioral and lifestyle interventions should be promoted and offered to people at high risk in the absence of conclusive evidence of efficacy, according to the “precautionary principle." The reasons for this include the potential health benefits to the public from these low-risk interventions (including physical activity, social and cognitive stimulation, healthy eating) and the fact that it may take many years before conclusive results are available. Nevertheless, I think that the public should be informed that, as with most treatments, the benefits from cognitive stimulation to individuals are not guaranteed and should not be promoted as such.

I believe that cognitive training holds much promise for dementia prevention and mental well-being, and that the key to unlocking the potential may be related to the inner speech or self-talk that individuals use when they are completing the tasks.

References:

Lincoln P, Fenton K, Alessi C, Prince M, Brayne C, Wortmann M, Patel K, Deanfield J, Mwatsama M. The Blackfriars Consensus on brain health and dementia. Lancet. 2014 May 24;383(9931):1805-6. Epub 2014 May 19 PubMed.

View all comments by Thomas Dannhauser

- Angel Golimstok
  Hospital Italiano
- Posted: 22 Jan 2016
One problem is that it is very difficult to demonstrate the usefulness of this method. Future guidelines should suggest a valid gold standard to verify the efficacy of brain training.

View all comments by Angel Golimstok