TAMPA, Fla. & NETANYA, Israel--(BUSINESS WIRE)--Neurolief, a neurotechnology innovator, today announces findings of the RIME US pivotal trial that demonstrate the safety and efficacy of the Relivion®, a novel external brain neuromodulation system for self-administered treatment of migraine. The study met all its endpoints with statistical significance.
“The results of this study are extremely promising for those seeking an effective, non-invasive, drug-free therapy for migraine,” said Stewart J. Tepper, MD, Professor of Neurology at the Geisel School of Medicine at Dartmouth, who was the principal investigator of the study.
“The Relivion, with its adaptive stimulation channels, targets major neural pathways responsible for migraine, thereby creating a synergistic neuromodulatory effect that maximizes the clinical benefits. “This may explain why it is the only neuromodulation technology that was able to demonstrate statistically significant results for complete freedom of migraine symptoms, in a placebo-controlled clinical trial,” added Dr. Tepper.
The Relivion® enables neuromodulation of brain networks associated with control of pain and other migraine related symptoms. To do so, the device utilizes three adaptive output channels which non-invasively transfer mild electrical pulses to the brainstem via six branches of the occipital and trigeminal nerves. Combined neuromodulation of both the occipital and trigeminal nerves was previously possible only with surgically implanted devices. The Relivion® is the first system to provide such combined neural activation non-invasively by the patient, without requiring surgical implantation.
The RIME study was a multi-center, prospective, randomized, double-blind, placebo-controlled clinical trial, conducted at leading clinical centers in the US and Israel. It evaluated the safety and efficacy of the device with 131 patients who met the International Classification of Headache Disorders (ICHD-3) criteria of migraine with or without aura. At 2 hours after treatment, 46% of patients in the active group reached complete pain freedom compared to only 11.8% in the control group. 75% of patients in the active group reached complete freedom of “Most Bothersome Symptom” (MBS- either phonophobia, photophobia, or nausea) 2-hours after treatment, compared to 46.7% in the control group. Complete freedom of migraine symptoms (freedom from pain as well as freedom from MBS) at 2-hours after treatment was significantly higher in the active group than in the control group (47.2% ver. 11.1%). Pain relief was also significantly higher in the active group than in the control group at 2 hours after treatment (60% vs. 37%). No serious adverse events were reported.
“The RIME study is an important milestone in making this novel medical technology available for the numerous patients who seek relief for their debilitating condition," said Chris Richardson, Neurolief’s Chairman. "We are committed to make it available for patients in Europe and the United States in the near future and continue to work with regulatory authorities to make this possible.”
Relivion® for treatment of migraine has already received CE mark in Europe and submission for this indication is now pending FDA review.
Dedicated to bringing relief to patients suffering from chronic neurological and neuropsychiatric disorders, Neurolief is creating a digital therapeutics platform of wearable clinically-proven neuromodulation solutions. This technology, which is made to be worn like a headset, is intended to offer highly-effective, safe treatment options that work with current pharmaceutical therapies or may provide an alternative to these therapies. It is designed to concurrently neuromodulate major neural pathways in the head, and thereby affect brain regions that are involved in control and modulation of mood and pain. Neurolief’s technology is currently studied for patients with migraine and major depression, and future indications may include insomnia, ADHD and additional chronic pain and neuropsychiatric disorders. The company is based in Israel, with US operations in Tampa, FL and is made up of highly experienced professionals with a proven track record in neurosciences, neuromodulation technology and the neurotech devices industry.