A self-administered, combined occipital and trigeminal neuromodulation device is safe and effective in the treatment of patients with acute migraine, according to the results of a study recently published in Headache.  

“Brain neuromodulation is a clinical proved medical technology that alters brain function through targeted delivery of gentle current,” Eran Schenker, MD, from George Washington University and Neurolief, Netanya, Israel, and colleagues wrote in the abstract. “The combined occipital and supraorbital transcutaneous neuromodulation product, is the first non-invasive digital therapeutics neuromodulation system that provides precise activation of major neural pathways in the head via several adaptive output channels for maximized clinical digital therapeutics effect.”

Neurons. Source: Getty

According to Schenker and colleagues, previous digital therapeutics devices were possible only through high-risk and costly implanted devices and this is the first time a produce provides effective therapy without the risk and costs of invasive procedures. 

To evaluate the performance and safety of a self-administered treatment for migraine using combined occipital and supraorbital treatment, researchers enrolled 55 patients in the randomized study and assigned them to treatment or sham cohorts. The respective mean baseline pain level was 5.7 in the treatment group and 5.4 in the sham groups. 

The researchers found a significantly reduced pain level among patients in the treatment group at 1 hour (41.38%; 95% CI, 20.57-62.18), 2 hours (32.84%; 95% CI, 2.88-62.8), and 24 hours (36.21%; 95% CI, 5.46-66.96). 

The responder rate was also significantly higher among patients in the treatment group when compared to the sham group at 1 hour (66.7% vs. 20%, P = .0014), 2 hours (66.7% vs. 32%, P = .0227),  and 24 hours (78.3% vs. 48%, P = .0401), according to Schenker and colleagues. 

While there was no statistically significant difference between the two groups in consumption of rescue medications and pain-free endpoints, it was found that the amount of pain free participants at 2-hours was more than twice as high among those in the treatment group (41.7%), compared to the sham group (20%).

“The Relivion product was tested in clinical studies and confirmed safe and highly effective in treating acute migraine” the researchers wrote.  “When used during migraine episodes the device clinical effectiveness was shown comparable, without the adverse effects associated with medications and with no limitation on the number or duration of treatments.”

Disclosure: Schenker is an employee of Neurolief.