Neurolief’s Relivion™ digital therapeutics wearable neuromodulation technology was featured during a keynote address by Prof. Alan M. Rapoport at the 4th Annual International Headache Symposium in Israel (IHSI). The address, titled “The New Acute Care Medications and Devices for Migraine and Cluster Headache,” included preliminary results of a randomized, double-blind, parallel group, sham-controlled clinical trial of Neurolief’s Relivion migraine treatment device. The study investigated the safety and performance of the device in delivering non-invasive combined occipital and trigeminal neurostimulation for treatment of migraine.
“The clinical study results strongly support the idea that Neurolief’s technology and the Relivion system’s combined stimulation of both the occipital and trigeminal nerves will result in a better outcome than stimulation of a single nerve,” said Dr. Rapoport, clinical professor of neurology at The David Geffen School of Medicine at UCLA (Los Angeles), past president of the International Headache Society (IHS), and the founder and director-emeritus of The New England Center for Headache, in Stamford, Conn. “The direction in which Neurolief is advancing with multi-channel neuromodulation and personalized treatment has great potential for migraine treatment in general, and I believe physicians will be very interested in it.”
Personalized Brain Neuromodulation Technology for Relief from the Debilitating Symptoms of Migraine: Migraine is a prevalent and debilitating primary headache disorder. In the U.S population, the prevalence of migraine is approximately 18 percent in women and 6 percent in men. The World Health Organization (WHO) estimates that 324 million persons worldwide have migraine. Migraine patients suffer from disabling symptoms that usually consist of a moderate to severe Headache lasting four to 72 hours, nausea and/or vomiting, phonophobia (fear of noise) and photophobia (fear of light). Seventy-five percent have a reduced ability to function during the migraine episodes and 33 percent require bed rest during their attacks.1 There is currently no cure for migraines, and over-the-counter medications often do not work. Patients with migraine are often refractory to medical treatment and some of the most effective antimigraine drugs such as Triptans have substantial side effects.2
Neurolief’s Relivion is a head-mounted neuromodulation device that is designed to treat migraines and depression. The Relivion provides precise modulated pulses simultaneously to six branches of the occipital and trigeminal nerves in the head via adaptive output channels around the patient head. The cloud-enabled device can connect to a mobile phone app, and learns over time to customize a particular personalized treatment for each patient.
“We have designed the Relivion as the next generation, digital therapeutics technology for brain neuromodulation. We believe that a personalized treatment tailored for each patient will make a real difference for the millions of sufferers who are not satisfied with their current treatment,” said Shmuel Shany, president and CEO, Neurolief.
“The Relivion is the first non-invasive brain neuromodulation technology that provides precise activation of major neural pathways in the head via several adaptive output channels, to maximize the therapeutic effect in migraine and depression. One of the challenges we faced in the development of this sophisticated technology was to adapt it for self-administered treatment, so patients can use it at the comfort of their home or community environment,” said Amit Dar, chief technology officer, Neurolief.
“The Neuromodulation treatment by the Relivion suppresses the secretion of chemicals in the brain that trigger pain. It also modulates the activation threshold of the neural system, training the nerves to react less severely the next time a migraine trigger is present. Previously, similar treatment has been available only via expensive surgical implants,” explained Dr. Eran Schenker, chief medical innovation officer.
Demonstrated Benefits of Combined Occipital and Trigeminal Neuromodulation: Neurolief’s randomized, double-blind, parallel group, sham-controlled clinical trial investigated the safety and performance of the Relivion treatment in 55 subjects with chronic or episodic migraine. As presented by Prof. Rapoport at IHSI 2019, the results demonstrate high effectiveness of the Relivion and are comparable and mostly superior to existing prescription drugs and to invasive procedures that target the same nerves.
Primary investigator Dr. Oved Daniel, neurologist and director of the Headache and Facial Pain Clinic at the Ramat Aviv Medical Center, Israel, led the Relivion clinical study, which took place at the Headache and Facial Pain Unit, Laniado Medical Center.
“Neurolief appears to have a very sophisticated brain neuromodulation technology that utilizes a unique set of digital therapeutics connected to Neurolief’s echo-cloud system, that will enable closed-loop personal treatment – including the ability for real-time treatment adjustments to improve treatment efficacy and minimize risks,” said Dr. Daniel. “The impressive results shown in the Relivion study support my hypothesis that concurrent activation of these neural pathways will elicit synergistic neuromodulatory effect with superior theraputic outcome.”
1 Lipton, R.B., et al., Migraine prevalence, disease burden, and the need for preventive therapy. Neurology, 2007. 68(5): p. 343-9.
2 Loder, E., Triptan therapy in migraine. New England Journal of Medicine, 2010. 363(1): p. 63-70.