App-Controlled Migraine Therapy Effective and Safe in Real-World Use, Study Finds

A drug-free digital therapeutic designed to treat migraines appears to be effective in real-world use, according to new data garnered from patient-users of the smartphone application-controlled device.

Liron Rabany

Nerivio, which is marketed by Theranica Bio-Electronics, is a remote electrical neuromodulation (REN) device that has been cleared by the FDA to treat chronic or episodic migraine. REN works by stimulating the nociceptive nerve fibers in the upper arm, activating an endogenous descending pain mechanism, according to Theranica. The smartphone application that controls the device also includes a secured personal diary in which patients can track symptoms before and after they use the device.

“As a prescribed digital therapeutic (i.e., electroceutical), the REN device enables prospective (real-time) collection of electronic patient-reported outcomes in real-world use, in a large group of users,” wrote corresponding author Liron Rabany, Ph.D., Theranica’s chief scientist.

A team of investigators from the company, Georgetown University Hospital, and the Mayo Clinic in Arizona, decided to use the data generated by the app to better understand how patients used and responded to the treatment, how treatment affected their need for medication, and whether patients experienced significant adverse events. Their findings were published earlier this year in the journal Frontiers in Pain Research.

The data set they used covered the period between October 2019 and May 2021. Patients were prompted to list their symptoms, pain level, and any medications they took at the start of treatment and again two hours after initiating the treatment.

A total of 23,151 treatments were recorded, and two-thirds (66.5%) of those treatments, the device was used as a standalone treatment. In one-fifth (20.6%) of cases, patients used Nerivio for at least 20 minutes but then used a prescription medication. In 12.9% of cases, patients used the device and then took an over-the-counter drug.

The investigators noted that 83% of the patients in the study were patients of headache clinics, and most had prescriptions for prescription-strength headache medicines. The fact that patients opted to use those drugs following a Nerivio treatment in just 1 in 5 instances is significant, the investigators argued.

“This suggests that treating with REN results in a substantial reduction in intake of prescribed pharmacological medications (and consequently may reduce the risk of developing medication overuse headache),” Rabany and colleagues wrote. “The current data also support the willingness of patients to adopt a drug-free treatment.”

On a patient-by-patient level, 2,514 patients were included in the study, and two-thirds (66.5%) said REN therapy led to pain relief at least half of the time; 22.6% said they became pain-free at least half the time they used the treatment.

The investigators also found that adverse events were low. Just 59 patients reported adverse events, and all but 3 were considered mild. None were labeled “severe.” The investigators said the data show the device holds up in real-world treatment, even outside of the clinical trial setting. “The current real-world clinical data confirm the findings of pre-marketing studies, namely that REN provides an efficacious, stable, and reliable treatment option for acute treatment of migraine in real world settings,” Rabany and her co-investigators concluded.