US study shows Israeli device effective against chronic migraines

Pharmacy benefit management firm MC-Rx places the wearable device as a preferred treatment on its formulary

 Theranica (photo credit: THERANICA)
(photo credit: THERANICA)

An electronic, wearable medical device that was developed in Israel has been shown to significantly reduce pain and other debilitating symptoms after two hours in patients with chronic migraines, according to a study published this month in the peer-reviewed journal Pain Reports.

A prospective, multi-center, open-label trial of Theranica’s Nerivio device demonstrated that remote electronic neuromodulation (REN) is an effective and safe treatment for patients with chronic migraines.

Specifically, the recent study tested 99 chronic migraine patients and found that nearly 60% of the patients who completed the research period experienced pain relief within two hours of treatment. Moreover, nearly 65% of those who experienced relief at two hours continued to experience sustained pain relief for at least 24 hours after treatment.

Additionally, more than 20% were pain-free at two hours. Moreover, nausea and other challenging migraine symptoms such as sensitivity to light and sound were also improved at the two-hour mark.

The device was also found to have a high safety profile, with only one of the participants reporting a mild, local, device-related adverse effect, which was resolved quickly after treatment.

Theranica CEO Alon Ironi speaks at a recent Jerusalem Post conference (Credit: Avshalom Sassoni)Theranica CEO Alon Ironi speaks at a recent Jerusalem Post conference (Credit: Avshalom Sassoni)

Nerivio is approved by the US Food and Drug Administration for use in acute treatment of episodic and chronic migraine in adult and adolescent patients. It is a smartphone-controlled wearable device that sends non-painful electrical waveforms to nerve fibers in the upper arm. That triggers conditioned pain modulation (CPM) in the central neural system, activating the body’s own analgesic mechanism.

Endogenous pain modulation is a broad term describing an array of actions that the central nervous system can execute to reduce pain. CPM is when pain in one body part is inhibited by pain in another.

In the case of the Nerivio, the device is able to trigger that system using a non-painful stimulation, said Theranica’s chief scientist Dr. Liron Rabany, who co-authored the study.

The Nerivio device controlled by an app on the patient’s smartphone allows patients to set the intensity of their treatment. Additionally, the app contains a migraine diary that can be shared with healthcare teams.

This study joins several previous studies that have already confirmed the effectiveness and safety of REN for acute treatment of episodic migraine in adults and adolescents.

“Chronic migraine is characterized by headaches experienced on at least 15 days per month,” said Dr. Brian Grosberg, director of the Hartford Healthcare Headache Center, who served as the primary investigator of the study. “People with chronic migraine not only have a higher frequency of migraine attacks, but their attacks tend to be more severe than episodic migraine patients.”

Approximately 3% of people with episodic migraine progress to chronic migraine, according to sources cited in the Pain Reports study. These headaches are most likely to affect Caucasian women.

Grosberg said that chronic migraine patients tend to use more medication to ward off these headaches. The challenge for doctors, therefore, is to relieve the migraine symptoms without over-medication that can lead to additional complications.

“Non-pharmacological interventions such as REN help meet this need by providing a drug-free treatment option,” he added.

The study published in Pain Reports involved those between 18 and 75 who had been diagnosed with chronic migraines. These patients were either not using any preventative medications, or were on stable dose for at least two months before the trial and continued with the same protocol alongside the additional treatment.

Participants were instructed to treat their migraine attacks within an hour of symptom onset using the Nerivio device, and to refrain from taking any medication for at least two hours after treatment. They were also asked to report their symptoms in an electronic diary before the treatment, at two hours post-treatment, and at 24 hours.

The study took place at nine US centers and included a four-week run-in phase and a four-week treatment phase in 2019 and 2020.

“To the best of our knowledge, this was the largest clinical trial of acute treatment of migraine specifically targeting chronic migraine patients,” Rabany said.

Earlier this month, Theranica announced a new partnership with MC-Rx, a pharmacy benefit manager, for its Nerivio device. MC-Rx serves millions of members across the US.

The deal places Theranica’s device under MC-Rx’s pharmacy benefit formulary, which means migraine sufferers who are prescribed the device by their healthcare providers will now have a clearer path for reimbursement.

“We are excited to continue our clinical development, adding ever-increasing solid evidence of the clinical benefit that REN brings to different sub-populations of people with migraine,” Rabany said. “Indeed, a recent scientific review that compared all current medical devices for the treatment of migraine concluded that Nerivio was the only one for which there is sufficient high-quality research, and thus the only one for which efficacy was well established.

“All people with migraine, adults or adolescents, should have the option of discussing a non-pharmacological therapy with their healthcare providers, as a first-line treatment option, or as an adjunct, to improve their migraine care,” she concluded.

This article was written in cooperation with Theranica.