Remote electrical neuromodulation safe, efficacious in adolescents with acute migraine
Click Here to Manage Email Alerts
AUSTIN, Texas — The use of remote electrical neuromodulation in adolescents with acute migraine was safe and efficacious as a nonpharmacological treatment option, according to a poster presented here.
“This is a real-world study looking at frequent users of remote electrical neuromodulation [using] the Nerivio (Theranica) device, a noninvasive neuromodulation device that is FDA-cleared for treatment of migraine in patients 12 years and older,” Teshamae S. Monteith, MD, associate professor of clinical neurology at the University of Miami Miller School of Medicine, told Healio. “There was a recent pivotal study showing with randomization that REN is effective for prevention when used every other day. That was a study done in adults, so based on those findings we decided to take a look at what the behaviors or response could be in adolescents.”
Researchers included 83 high-frequency users aged 12 to 17 years (89% girls) and calculated the mean monthly migraine treatment days each month as a proxy measure for monthly headache days.
In the first month, a mean of 12.6 treatment days was recorded, which decreased to 9 days in the second month and 7.4 days in the third month.
“In addition to that, responder rate for pain relief was 61%, so a great response,” Monteith said.
Pain freedom was reported in 24.5% of patients, while functional disability relief and functional disability freedom was reported in 67.4% and 41.3%, respectively.
One minor adverse event of transient arm pain was reported, but the patient continued to use the device.
Based on these findings, Monteith noted, which were consistent with data in the randomized controlled trial of adult patients, the FDA cleared the device and added the indication of preventive treatment in adolescents.
“There are many benefits to considering a device, which can be used with medication or as a standalone,” Monteith said. “So now adolescents can consider nondrug options. We have a device that is highly effective for prevention of migraine and is incredibly safe, is easy to use and intuitive and is effective for both acute relief and protection.”