Israeli team’s electronic migraine relief band scores European approval
First device of its kind safe for outpatient use
An Israeli band that transmits electrical signals and stops migraine pain has been approved by the European Commission for pharmaceuticals.
Relivion, patented by Netanya-based Neurolief, is a brain neuromodulation device geared toward helping individuals who suffer from a range of neurological and neuropsychiatric disorders, including migraine headaches.
The band is connected to a cellular application directed by the patient. It works by transmitting electric currents to the brain. The signals stimulate six major nerve branches around the head, which conduct the stimulation directly to the brainstem. This creates “neuromodulation,” which blocks the nerve signals that cause the pain.
Over time, the system “learns” the optimal treatment for each specific patient.
It is the first device of its kind considered safe for outpatient use.
Migraines can cause moderate to severe pain, including throbbing or pulsing. Often, the pain occurs only on one side of the head. Side effects can include nausea, weakness and sensitivity to light and sound.
According to the Migraine Research Foundation, migraines are the third most prevalent illness in the world. Nearly one in four United States households have someone who suffers from such headaches. The foundation said that around 12% of the American population – including children – suffers from migraines. They are more common in women than men.
In Israel, the prevalence of migraines among those age 21 and over is 5.4%, affecting 3.2% of men and 7.5% of women, according to Hadassah Medical Center.
Neurolief was founded in 2013 by Shmuel Shany and Amit Dar. To secure approval in Europe, the company carried out a double-blind clinical investigation in which 55 migraine sufferers were split into two groups. One was treated with the device, while the other received a placebo device. Two hours after the start of the treatment, 76% of the group treated with Relivion reported feeling relief, according to Neurolief, compared to 31% of the control group. Furthermore, in the treatment group, 43% of those who reporting moderate or severe pain prior to the treatment reported being pain free after two hours.
The company is already working on the next generation of the Relivion device by collecting data from thousands of migraine sufferers around the world using the device and creating treatment algorithms that could ultimately lead to the fastest and most effective pain relief during a migraine attack.
The device is presently in a clinical study for major depression at Be’er-Ya’acov mental health center with what the company describes as “outstanding interim results.”
For now, the device will only be available in Europe. The Relivion will be available in Israel next year.