A new clinical trial for adolescent migraine is underway, and it’s harnessing the power of consumer technology to collect better data and make study participation easier. The BRAiN-M Study, which is examining whether melatonin (a natural supplement) is effective in preventing teenage migraine, uses Fitbit devices and an online “headache diary” to collect data from study participants remotely.
Besides trying to figure out how to prevent teenage migraine, the study’s lead investigator, Dr. Amy Gelfand of UCSF, is looking to make pediatric migraine clinical trials more inclusive and accessible.
Gelfand says that participation in conventional pediatric migraine clinical trials is often too difficult for families to orchestrate. Most require many in-person visits, which results in missed school for the kids and missed work for their parents. This problem is exacerbated for families who do not live near the study clinic because of the long travel distances.
By leveraging technology, the BRAiN-M Study is able to remove these barriers to participation. How big of a deal is this? Huge! There was a pediatric migraine study conducted in 2013 (Powers et al JAMA) that highlighted a startling statistic: 44% of those that declined to participate in the study cited either “distance too far” or “did not have time to participate” as their reason for declining. That’s a pretty significant number.
“I wanted to design a study that worked for families with hectic schedules and kept children from missing school. After all, we’re treating their migraine problem in part so that they can go to school more, not less! By conducting most of this study remotely using web, mobile and wearable technologies, we are able to lessen the burden of study participation,” says Gelfand.