By David Tuller, DrPH
The University of Exeter is now recruiting for a study of “brain training” as a treatment for prolonged cognitive dysfunction after a bout of Covid-19. I found out about this via a post on X. The post highlighted a message that had been sent to an unidentified patient from their medical providers: “Are you experiencing brain fog or memory problems after having Covid-19. The new BEACON trial is testing a brain training app to improve brain health.”
The message included a link for the trial website. In line with the study’s name, the pages on the site all feature drawings of people using phones or lanterns to cast light on the ground in front of them. Ah, beacons! Got it! The images are colorful and clever, but I wish investigators would resist the urge to endow their studies with cutesy names and acronyms.
According to the site, the study will include 1600 participants. Those in the intervention arm will, over the course of 26 weeks, engage in a series of brain games on their phones using a dedicated app. Cognitive testing will take place at baseline, after six weeks, and at the end of the six-month intervention period. Beyond that, the site is remarkably uninformative, given that the study has entered the recruitment phase. We are told that the study is being conducted by “world-leading experts” at Exeter. But who are they? Why would people sign up for a study about which they know almost nothing?
(To be fair, the site does include a phone number and an e-mail address for those who want to find out more. But why should someone need to go elsewhere for information that should be on the trial website itself?)
According to the site, the study “will help us develop new and accessible ways to help the millions of people suffering from Long Covid.” Great! But how do the researchers know before they conduct the study that this will be the result? They obviously hope the trial will yield actionable answers, but they seem to discount or overlook the possibility that it could all be a big fat bust.
This prediction of success is reiterated in the site’s mention of the study’s control group. Here’s what it has to say about that: “This [control] group will make sure we can prove the benefits of brain games for people with Long COVID.”
Excuse me? They’re 100% certain that, as long as they include a control group, their study will definitely “prove the benefits” of their intervention? I guess scientific skepticism has flown out the window here. Whether these statements represent naivete, grandiosity, or just unintentionally problematic and confusing language, it is not cool for researchers to appear to be promising positive results.
I assume this level of certainty, which suggests an absence of equipoise, is not the official stance of the research team; if it were, it would seemingly be unethical to conduct a trial rather than just offering people the intervention. But I’m concerned that appearing to assure people that the study will yield the desired findings, which is how some or many prospective participants would likely read that sentence, could lead to significant bias. Such statements seem rather ill-advised.
Luckily, the University of Exeter site offers more information than is available on the trial site itself. The study is funded by the National Institute for Health and Care Research. Those in the intervention arm are expected to play the games for three ten-minute sessions a week. According to the Exeter site, this approach has shown benefit in older patients with early indications of cognitive deterioration, although no link or reference is provided for this claim.
The Exeter site includes the following statement from Anne Corbett, a professor of dementia research and the lead investigator of BEACON:
“We know that people who are experiencing cognitive symptoms with long Covid can find it harder to get back to their normal lives, so it’s really important that we find a way to treat these symptoms. Online brain training games could be a great solution if they prove effective, since they are easy to roll out to large numbers of people and are relatively cheap.”
I’ll be curious if, in the near future, the investigators fix the language suggesting success is a slam-dunk, beef up the trial website with details and actually post an FAQ. I’d also like to see the trial registration, which is not on clinicaltrials.gov, and the protocol, assuming there is one. Perhaps I will need to write to the lead investigator. Stay tuned!
Everything seems to revolve around health economics in the UK now. I imagine this study might find some marginal gains for people – after all, if you practice puzzles and games you’re very likely to get better at them and if you’re told that something will work by people who come across as interested in you then you’re probably more likely to report that it has worked. And to be a participant, you’re probably already hopeful that it will prove effective. I understand that the control group will be Long covid patients given a different task that isn’t brain training, but if that task is less interesting than the brain training games then the participants may be unimpressed and become disillusioned with the study, may perhaps realize that they’re in the control arm and report accordingly and without the same bias as those in the treatment arm. I’ll be surprised if there’s a good follow up of the participants for whom it hasn’t worked, who dropped out or couldn’t manage the brain training games and didn’t improve or who got worse. I envision that success will be claimed, a “relatively cheap” (money saving) therapy will be rolled out and adopted and patients who are non-compliant for whatever reason or who report deterioration will be given short shrift.
Things started going wrong, I think, when doctors started playing health economists by touting their studies/hypotheses as money saving strategies to healthcare commissioners and to research funding bodies and when they got a positive response back rather than being reminded to play by the rules of science rather than economics. I strongly believe that treatments should be evaluated and research funding should be allocated without any money-saving carrot being dangled in front of funders’ and commissioners’ noses. Only then will we know that the best, most effective treatments have been found. The health economists could then weigh in with their arguments as to what can be funded but they would have to explain to patients and the public when an inferior cost-saving treatment is being adopted, rather than it being supposedly supported by scientific evidence.
I wonder if the BEACON team can explain how this exercise can improve the abnormal level of neurochemicals in the brains of Long COVID (and ME/CFS) patients, assuming that the results of this pilot study apply to their sample. Do they think these neurochemicals are irrelevant to the symptoms experienced? Are they even aware of such findings? I suspect not, or that their almighty mind over matter approach will fix things. March forward into the fog!
Here is the link to the neurochemical study:
https://pubmed.ncbi.nlm.nih.gov/38588934/