Nerivio REN Demonstrates Greater Efficacy in Migraine When Combined With In-App Behavioral Intervention

Dawn Buse, PhD, FAHS

By combining the Nerivio remote electrical neuromodulation (REN) device with Nerivio’s Guided Imagery, Education and Relaxation (GIER) optional in-app behavioral intervention, a higher proportion of patients achieved consistent pain relief and improvement of their acute migraine compared with those on REN treatment alone.^1,2

The dual-arm study, published in Pain Medicine, examined 85 patients with migraine at least 18 years of age 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 (P = .008), consistent improvement in function (P = .014), and consistent return to normal function (P = .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 statement.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.

READ MORE: Acute Long-Term as Needed Rimegepant Reduces Monthly Migraine Days

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%; P = .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."

The study’s main limitation is that it was observational in nature, with the authors noting that future prospective random-allocation studies are needed to further establish the current results and to explore long-term use. Although, the observational real-world design of this study did have an advantage of providing valuable information on the real-life effectiveness of the interventions, which had not been previously observed before.²

Nerivio—without GIER—had been previously evaluated in a real-world setting that included more than 100,00 patients with migraine. In addition to showing an effective and safe profile, 50% response in pain relief was recorded in 66.5% of those who used REN as a standalone treatment, and in 22.6% for pain freedom. Furthermore, 61.3% of these patients achieved reduction in their functional disability in at least 50% of their treatments, and 29.8% of users achieved return to normal function in at least 50% of their treatments.³

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

3. Large real-world evidence analysis provides comprehensive evaluation of Nerivio as an effective acute treatment for migraine. News release. Theranica BioElectronics. January 19, 2022. Accessed February 18, 2022. https://www.prnewswire.com/news-releases/large-real-world-evidence-analysis-provides-comprehensive-evaluation-of-nerivio-as-an-effective-acute-treatment-for-migraine-301463774.html