Electrical Neuromodulation Device Improves Symptoms of Acute Migraine

Nerivio is the first FDA-cleared smartphone-controlled prescribed wearable device for the acute treatment of migraine.

The combination of the Nerivio remote electrical neuromodulation (REN) device with Nerivio’s Guided Imagery, Education and Relaxation (GIER) optional in-app behavioral intervention led to a greater proportion of patients experiencing consistent pain relief and improved symptoms of their acute migraine versus treatment with REN treatment alone.1,2

In a dual-arm study published in Pain Medicine, researchers evaluated 85 patients with migraine who were at least 18 years of age and who treated their attacks with REN in parallel with the GIER intervention (REN+GIER) and individually matched them on age and sex with 85 patients who used REN alone. At 2 hours post-treatment, the REN+GIER group displayed statistically significantly higher proportion of patients achieving consistent pain relief (= .008), consistent improvement in function (= .014), and consistent return to normal function (= .005) than the REN-only group.

"It is well established that behavioral interventions such as diaphragmatic breathing, guided imagery and relaxation practices have preventive benefits for people living with migraine," lead investigator Dawn Buse, PhD, FAHS, professor of neurology, Albert Einstein College of Medicine, Montefiore Medical Center, said in a press release.1 "This study helped confirm our hypothesis that these interventions can help during a migraine attack as well. Migraine attacks are typically associated with physical pain and additional debilitating symptoms."

In October 2020, Nerivio became the first FDA-cleared smartphone-controlled prescribed wearable device for the acute treatment of migraine. Since then, it has received additional authorization for acute treatment of episodic and chronic migraine in adult and adolescent patients. Nerivio’s GIER feature is a 25-minute video played on a user’s smartphone during their REN treatment that comprises of 3 relaxation techniques: diaphragmatic breathing, progressive muscle relaxation, and guided imaging. Patients may watch and/or listen to the video when Nerivio is activated for an acute treatment.

Consistent pain relief was observed in 79.4% of REN+GIER responders compared with 56.8% of those on REN-only. Furthermore, 71.3% of those in the REN+GIER group demonstrated consistent improvement in function compared with 52.5% of REN-only responders. Consistent return to normal function was found in 37.5% and 17.5% of REN+GIER and REN-only responders. Notably, consistency of pain freedom was qualitatively higher in the REN+GIER group, but the difference did not reach statistical significance (REN+GIER: 32.9%; REN-only: 20.0%; = .056).2

"Not surprisingly, this combination of symptoms tends to be accompanied by emotional and physical anxiety and distress. The natural protective ‘fight or flight’ reaction of the nervous system, while well intentioned, is actually counterproductive during a migraine attack," Buse added.1 "Relaxation activities can provide comfort as well as help reduce muscle tension, encourage circulation, and generally moving the body and mind into a more comfortable and relaxed state. Our research demonstrates how expanding the patient's toolbox with features such as GIER, incorporated into the Nerivio app, can be utilized to enhance the therapeutic benefits of neurostimulation by calming the nervous system while at the same time addressing the patient's wellbeing."

REFERENCES


1. Peer-reviewed study shows positive impact of Nerivio’s Guided Imagery, Education, and Relaxation (GIER) feature on migraine treatment response. News release. Theranica. February 16, 2022. Accessed February 18, 2022. https://www.prnewswire.com/news-releases/peer-reviewed-study-shows-positive-impact-of-nerivios-guided-imagery-education-and-relaxation-gier-feature-on-migraine-treatment-response-301483460.html

2. Buse DC, Rabany L, Lin T, Ironi A, Connelly MA, Bickel JL. Combining guided intervention of education and relaxation (GIER) with remote electrical neuromodulation (REN) in the acute treatment of migraine. Pain Med. Published online February 11, 2022. doi:10.1093/pm/pnac021