A peer-review study (NCT04161807), which used an FDA-cleared acute migraine treatment device (Nerivio; Theranica, Montclare, NJ), shows significant improvement for individuals with chronic migraine who experience at least 15 headache days per month. The study demonstrates the utility of incorporating remote electrical neuromodulation (REN) into usual care of chronic migraine.
The study, published in Pain & Therapy, evaluated 38 individuals with chronic migraine and assessed REN's efficacy in treating the symptoms of migraine with or without aura. With the treatment device, 73.7% of participants achieved pain relief at 2 hours and 26.3% were pain free in at least half of their treatments. Of the participants, 84.4% experienced consistent sustained pain relief at 24 hours and 45% had sustained pain relief at 24 hours in at least 50% of their treated attacks. The study thus showed that REN provides consistent response rates from treatment to treatment, with no evidence of reduction in therapeutic benefits over time. Incidence of device-related adverse events was less than 2%.
The FDA-cleared prescribed therapeutic wearable device is designed to use REN to activate the body's native conditioned pain modulation (CPM) mechanism to treat pain and accompanying migraine symptoms. The device was recently named one of TIME's best inventions of 2019.
"Chronic migraine is often overlooked in acute migraine treatment studies, which focus instead on episodic migraine," said lead author Hida Nierenburg, MD, director of Headache at Nuvance Health, a not-for-profit health system in New York State's MidHudson Valley region, and western Connecticut. "This is unfortunate as those who suffer from chronic migraine need well-tolerated and effective solutions that can be used across multiple migraine attacks. REN is a promising approach that demonstrates good efficacy for chronic migraine patients. The REN approach also offers these frequent users a treatment modality that is not associated with medication overuse headache."
"The study is an important milestone in evaluating Nerivio for chronic migraine in addition to episodic migraine," said Alon Ironi, chief executive officer of Theranica. "We were particularly happy with the consistent results for the study participants across multiple treatments. Consistent efficacy is key for patients to have confidence in their therapy and maintaining quality of life. Patients need to know that if the treatment works for them, they can rely on it and won't have to look elsewhere in a month."